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News
Rebecca Lumley
29 Jun 2022

UPDATED: COVID-19 Pharma Development Tracker

The latest coronavirus updates and developments impacting the global pharmaceutical supply chain

29 June

Advisers to the US Food and Drug Administration have recommended a change to the design of COVID-19 booster vaccines this autumn in order to protect against the most recently circulating variants. The FDA's Vaccines and Related Biological Products Advisory Committee voted 19-2 that the next round of COVID booster shots should be effective against the Omicron variant. The FDA plans to decide on the design of the boosters by early July.

28 June

The US Food and Drug Administration's advisory committee is set to meet today to discuss preparations for the likely wave of Omicron infections this winter. They will discuss whether to deploy vaccines that specifically target the Omicron variant, which includes Moderna's bivalent vaccine and candidates from the Pfizer/BioNTech collaboration. 

Chinese biotech Clover Biopharmaceuticals has said that a booster shot of its COVID-19 vaccine candidate significantly increased antibody response against the Omicron variant from levels seen after two primary doses. A third dose of the SCB-2019 vaccine candidate caused a 19-fold increase in neutralising antibody levels against the Omicron BA.2 subvariant from pre-booster levels. 

24 June

An experimental COVID vaccine from Sanofi and GSK has been found to be effective against the Omicron variant, according to late-stage data. The bivalent vaccine targets the Beta variant, which was first identified in South Africa in late 2020, as well as the original strain of the virus. In a trial involving 13,000 adults, the vaccine demonstrated an efficacy rate of 64.7% against symptomatic COVID and 72% against the Omicron variant. 

The European Medicines Agency (EMA) endorsed Valneva's COVID-19 vaccine this week, though it remains unclear whether the company's supply agreement with the European Commission will continue. The French vaccine maker has been trying to salvage the deal after the company's marketing application was delayed due to the EMA requesting more information. The original deal was for up to 60 million doses, but the European Commission has since indicated that it would like to reduce the order. 

22 June

Moderna's Chief Executive Stephane Bancel has said the company's variant-targeting COVID-19 vaccine will be ready to ship in August as the company has been manufacturing doses ahead of regulatory approval. He said that all the data would be filed by the end of June and expressed hope that the vaccine would be approved by August. Similarly, Pfizer CEO Albert Bourla confirmed that vaccines targeting Omicron and other variants are in development, adding that the company would be able to quickly adapt their shots as the virus mutates. 

Moderna also announced plans for a new COVID-19 vaccine facility this week. The company will build a new research and manufacturing centre in the UK which will be used to develop vaccines against new COVID-19 variants and other respiratory illnesses. 

17 June

A new, peer-reviewed study has found that the Omicron variant of the coronavirus is less likely to cause long COVID than previous variants. The study, conducted by researchers at King's College London, found the odds of developing long COVID after Omicron infection were 20% to 50% lower compared to the Delta variant. This figure varied depending on the person's age and when their last vaccination was. 

15 June

Several European Union countries have called on Pfizer and other vaccine makers to renegotiate their contracts, saying that millions of doses that are no longer needed could go to waste. Countries are hoping to reduce their vaccine supplies after placing huge orders in the midst of the pandemic. The issue was discussed on Tuesday at a meeting of EU health ministers in Luxembourg.

Advisers to the US Food and Drug Administration have unanimously recommended that the agency authorises the Moderna COVID-19 vaccine for children aged between 6 and 17. A committee of outside experts also met on Wednesday to discuss the authorisation. 

14 June

Sanofi says an upgraded version of the COVID-19 vaccine candidate it is developing with GSK showed potential to provide protection against the virus's main variants of concern, including the Omicron BA.1 and BA.2 strains, when used as a booster dose. The GSK-Sanofi vaccine candidate is currently undergoing review by the European Medicines Agency. The French drugmaker added that the vaccine was shown to significantly boost antibody levels against a number of variants of concern during two trials. 

Valneva lost around a quarter of its market value on Monday (June 13) after the company disclosed the future of its COVID-19 vaccine is in jeopardy. Valneva has been trying to salvage a deal with the European Commission, which indicated it would terminate an advance purchase agreement for up to 60 million doses. Oversupply is thought to be the reason for the potential deal termination. 

The World Bank has approved a loan of €454.4 million to help South Africa fund COVID-19 vaccine purchases. The funding will retroactively finance the procurement of 47 million doses by the South African government. 

13 June

US Food and Drug Adminstration (FDA) reviewers have said the Moderna COVID-19 vaccine appears safe and effective for use in children aged six months to 17 years. The panel noted that the vaccine has a similar side effect profile in children as it does in adults, as well as generating a similar immune response. A committee of scientists will meet later this week to vote on whether to recommend that the FDA authorise the vaccine for use in children. 

The antiparisitic drug ivermectin does not meaningfully reduce the time needed to recover from COVID-19, according to a large study published yesterday. It is the largest of several clinical trials to show the drug, which was touted as a treatment since the beginning of the pandemic, is not effective against the virus.

7June

The FDA advisory committee has recommended that the agency approve Novovax's COVID-19 vaccine, a late entrant to the vaccine field, for use in adults. If Emergency Use Authorization is granted by the FDA, the Novavax COVID-19 vaccine would become the first protein-based COVID-19 vaccine available in the U.S.

Stanley C. Erck, President and Chief Executive Officer, Novavax said: "The advisory committee's positive recommendation acknowledges the strength of our data and the importance of a protein-based COVID-19 vaccine developed using an innovative approach to traditional vaccine technology. In today's VRBPAC meeting, we heard the overwhelming support for our vaccine from physicians, healthcare organizations, and consumers who are eagerly anticipating a protein-based vaccine option."

6 June

Pfizer announces plans to invest $120 Million to produce PAXLOVID, their COVID-19 oral treatment, at the Kalamazoo, Michigan site. The move further strengthens the drug maker's commitment to US domestic manufacturing.

Mike McDermott, Chief Global Supply Officer at Pfizer commented: “Pfizer’s Kalamazoo facility has been at the forefront of pharmaceutical manufacturing for more than 135 years through the legacy company Upjohn. The Kalamazoo facility uses some of our most innovative manufacturing technology and has been essential in Pfizer’s fight against COVID-19, producing nearly one billion doses of COVID-19 vaccine at the site to date. Through this expansion, we will continue to invest in the next generation of manufacturing and supply chain resilience.”

31 May

The results of a recent blood survey show that South Africa experienced a fifth wave of COVID-19 infections despite 97% of the population having antibodies due to previous infections or vaccination. The study examined 3,395 samples from blood donors earlier this year, which showed that 87% of South Africans had previously been infected with the virus, while just over 97% had either previous infection, vaccination, or both. The findings demonstrate the ability of the Omicron variant, particularly its BA.4 and BA.5 sublineages, to infect those who already have protection from the disease. 

Some US doctors are changing tack when it comes to recommending use of Pfizer's oral COVID-19 antiviral Paxlovid for lower risk patients, despite usage spiking last week. This comes after an advisory from the US Centers for Disease Control and Prevention (CDC) saying that patients can experience a recurrence of COVID-19 symptoms after completing a course of Paxlovid treatment and recommending that they isolate again for five days if this happens. Speaking to Reuters, infectious disease specialist Dr. Sandra Kemmerly noted that the possibility of an extended quarantine period is 'not a crowd pleaser' and said: 'For those people who are really not at risk.. I would recommend they not take it.' 

25 May

The US Centers for Disease Control and Prevention (CDC) has published a report about post-COVID conditions in adult survivors of the disease. The report finds that COVID survivors have twice the risk for developing pulmonary embolism or respiratory conditions, while one in five survivors between the ages of 18 and 64 experienced at least one condition that may be attributable to previous COVID. 

Nigeria has received 4.4 million doses of the Johnson & Johnson COVID-19 vaccine from Spain, in addition to 2 million doses from Finland, Greece and Slovenia. Faisal Shuaib, head of the National Primary Health Care Development Agency (NPHCDA), said the goal was to vaccinate 70% of its population, but Nigeria is currently far off its target. 

Multiple NGOs and civil society groups have called for US President Biden to press for changes in a draft agreement on waiving intellectual property rights for COVID-19 vaccines. In a letter sent to Biden on Monday, the group said an 'outcome document' reached after months of discussions between the main parties - the US, European Union, India, and South Africa - fell short of its goal of removing IP barriers for COVID vaccines. The issue is expected to be discussed during an informal meeting at the World Economic Forum in Davos, Switzerland this week. 

24 May

The US Centers for Disease Control and Prevention (CDC) issued an advisory today saying that patients who experience a recurrence of COVID-19 symptoms after completing treatment with Pfizer's oral antiviral Paxlovid should isolate again for five days. Pfizer has said rebounding symptoms are rare, but some social media users have reported symptoms coming back in recent days. 

18 May

The US National Institutes of Health is in talks with Pfizer about studying whether a longer course of the company's COVID-19 antiviral treatment Paxlovid is needed to prevent reinfections. NIAID Director Anthony Fauci said: 'We're going to be planning what studies we're going to be doing relatively soon, within the next few days' in order to determine whether a longer course is needed. More than 660,000 courses of Paxlovid pills have been administered in the US so far. 

The world is no better prepared to deal with a new pandemic than it was pre-COVID, and may actually be in a worse position due to the financial toll, according to a World Health Organization panel set up to evaluate the global response. The Independent Panel for Pandemic Preparedness and Response said this is due to a lack of progress on reforms such as international health regulations. While the report acknowledged some progress, it concludes that changes are moving much too slowly. 

13 May

Swiss drug regulator Swissmedic has authorised the use of Moderna's COVID-19 vaccine for children between the ages of six and eleven. Moderna said the approval was for two 50 microgram doses. 

South Korea says it will provide COVID-19 vaccines and other medical supplies to North Korea, after the North reported its first outbreak of the virus. At least one person confirmed to have COVID-19 has died in North Korea and the disease is said to be spreading 'explosively'. Before this week, the country had reported no cases since the beginning of the pandemic. 

11 May

The US Food and Drug Administration has approved a new indication for Olumiant (baricitinib) for the treatment of COVID-19 in hospitalised adults requiring supplemental oxygen, mechanical ventilation or extracorporeal membrane oxygenation. Olumiant is the first immunomodulatory treatment for COVID-19 to receive FDA approval. 

The head of the World Health Organization has criticised China's zero-Covid policy, saying it is unsustainable. WHO Director-General Tedros Adhanom Ghebreyesus said a shift in Chinese policy 'would be important' given what is now known of the virus and what is expected in the future. 

BioNTech completed a Phase II clinical trial of its COVID-19 vaccine in China in January, but has yet to release its results. The mRNA vaccine, developed with Pfizer, is one of the most widely used COVID-19 vaccines worldwide but has not yet received approval in China, which has vaccinated the majority of its population with domestically-produced non-mRNA vaccines. 

Novavax shares fell almost 20% in premarket trading on Tuesday due to uncertainty over global demand for the company's COVID-19 vaccine. The company said in September that it was aiming to deliver 2 billion doses in 2022. It confirmed this week that it delivered about 42 million doses in the first quarter of the year and added it has not yet received an order from Gavi, the global vaccine alliance.

9 May

A new study shows severe obesity may weaken the effectiveness of COVID-19 vaccines in those who have never been infected with the coronavirus. Among those in the study who had not been previously infected and received the Pfizer-BioNTech vaccine, patients with severe obesity had antibody levels more than three times lower than normal-weight individuals. Among those who received Sinovac Biotech's CoronaVac, those with severe obesity and no prior infection had antibody levels 27 times lower than normal weight people, according to data being presented this week at the European Congress on Obesity in the Netherlands. 

BioNTech announced today that its first-quarter sales and earnings more than tripled thanks to demand for its COVID-19 vaccine, developed with Pfizer. However, the German company reaffirmed its forecast for a full-year decline in vaccine sales, predicting revenues between €13 billion and €17 billion for 2022, down from €19 billion last year. The company says a high volume of orders placed in late 2021 and the emergence of the Omicron variant contributed to the surge in Q1 sales. 

5 May

The US Food and Drug Administration has restricted the use of Johnson & Johnson's COVID-19 vaccine due to the threat of rare but serious blood clots. In a statement on Thursday, the agency said its use was limited to those 18 and older who cannot access other vaccines. Also excluded from the restrictions are those who 'elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine'. 

4 May

A new study has found that people who experience severe COVID-19 infections suffer the same level of cognitive impairment as people between the ages of 50 and 70. This is the equivalent of losing 10 IQ points, according to researchers from the University of Cambridge and Imperial College London. It found that cognitive recovery is gradual at best and many people continue to report cognitive symptoms six months after infection. The symptoms they report include fatigue, brain fog, problems recalling words, sleep disturbances, anxiety and even post-traumatic stress disorder. 

The Omicron subvariant BA.2.12.1 has been attributed as the cause of rising COVID-19 cases in the US. So far it is spreading 25% faster than its parent virus, BA.2, and accounts for nearly 37% of all cases across the US, according to estimates from the Centers for Disease Control and Prevention. 

2 May

Moderna says its COVID-19 vaccine for children under six years old will be ready for review by the US Food and Drug Administration (FDA) when it meets in June. The company sought emergency use authorisation from the FDA last Thursday. Moderna's chief medical officer, Dr Paul Burton, said the company is "very confident" going into the application review. 

Pfizer says its COVID-19 oral antiviral treatment Paxlovid is not effective at preventing coronavirus infection in members of the same household, according to results from a large trial. The trial enrolled 3,000 adults who were household contacts exposed to an individual experiencing symptoms and having recently tested positive for COVID-19. Those who took a five-day course of Paxlovid were 32% less likely to become infected than those taking the placebo, however the results were not statistically significant and could have been due to chance. 

AstraZeneca has said its vaccine still has market potential, despite expected global oversupply of doses and delay in US approval. CEO Pascal Soriot said on Friday: 'We believe this vaccine still has potential, it's very easy to administer and distribute. The volume in the future will be less because people probably will only need one booster per year and not everyone will take it.'

A US Food and Drug Administration committee is set to review Novavax' COVID-19 vaccine in early June. The FDA's Vaccines and Related Biological Products Advisory Committee will review the NVX-CoV2373 vaccine for active immunisation against SARS-CoV-2, making it the first protein-based COVID vaccine to be reviewed by the committee. 

26 April

The US Food and Drug Administration (FDA) has granted the first full approval for treatment of COVID-19 in children 28 days and older to Gilead Science's drug remdesivir. The announcement comes months after the drug's emergency use authorisation was expanded to include children below 12 years of age and weighing at least 3.5 kg. It is the first approved COVID-19 treatment for children younger than 12. 

French vaccines company Valneva has secured new financing with US-based healthcare investment firms Deerfield Management Company and OrbiMed. Valneva said it had agreed to increase the principal amount of its existing $60 million debt financing agreement with up to an additional $40 million with the Deerfield and OrbiMed. The extension would provide Valneva with immediate access to $20 million, with an additional $20 million available upon conditional approval of its COVID-19 vaccine candidate by the European Medicines Agency (EMA). Valneva's inactivated vaccine candidate VLA2001 has been conditionally approved in the UK, but the EMA has requested more information from the company. 

25 April

An experimental treatment from Shionogi & Co has shown rapid clearance of the virus that causes COVID-19, according to new data from a Phase II/III clinical trial. The pill, S-217622, demonstrated "rapid clearance of the infectious SARS-CoV-2 virus" and is now being evaluated by Japanese regulators. Shionogi is said to have global aspirations for the antiviral once approved. 

Vaccines company Valneva says the European Medicines Agency has asked it to provide more information over its COVID-19 vaccine candidate, despite Valneva's expectation that the vaccine would be approved by the end of this month. The VLA2001 vaccine is easier to store than market rivals as it does not require ultra-cold storage and was approved in the UK earlier this month. 

22 April

The World Health Organization (WHO) endorses the use of Pfizer's COVID-19 oral treatment Paxlovid in high-risk patients after an analysis of trial data showed the therapy dramatically cut the rate of hospitalisation. It says Paxlovid is by far the most potent of all available treatments. 

CureVac and GlaxoSmithKline's second-generation vaccine candidate targeting two recent COVID variants has been shown to be highly effective in preclinical studies on mice, according to CureVac. The study showed the bivalent vaccine candidate, designed to work against Beta and Delta variants, elicited neutralising antibody levels comparable to monovalent vaccine candidates targeting only one of the variants. 

20 April

Moderna says a COVID-19 booster designed to target the Beta variant as well as the original coronavirus generated a better immune response against a number of virus variants, including Omicron. The company says the results are a good sign for future shots targeting two variants. 

Poland has declined to take or pay for any more COVID-19 doses under the European Union's supply contract, a move which will likely cause a legal battle with manufacturers. The country has seen lower vaccine uptake than most of the EU and has surplus vaccine stock, which it has sold or donated to other countries. However, Poland cannot directly terminate the contract for the supply of vaccines as they were signed by the European Union and manufacturers. Polish Health Minister Adam Niedzielski said the consequence would be a 'legal conflict, which is already taking place'. 

19 April:

Researchers are considering trialling Pfizer's oral antiviral Paxlovid for the treatment of long COVID after reports of two patients experiencing relief from their symptoms by using the drug. Long COVID affects approximately 30% of people previously infected with the coronavirus and is synonymous with symptoms such as pain, fatigue, brain fog, breathing issues and exhaustion after light physical activity.

Japan has approved Novavax Inc's COVID-19 vaccine, which is to be manufactured domestically by Takeda Pharmaceutical Co. The Japanese government has agreed to purchase 150 million doses of the recombinant protein type vaccine. Most COVID vaccines administered in Japan to date have been the mRNA type manufactured by Pfizer and Moderna. 

14 April:

The US has renewed the COVID-19 public health emergency, allowing millions to keep access to free tests, vaccines and treatments for at least three more months. The public health emergency has been renewed each quarter since January 2020 and was due to expire on April 16. The US Department of Health and Human Services said it would give 60 days' notice before termination or expiration. 

The UK will expand access to Pfizer's COVID-19 treatment Paxlovid by adding it to a trial to assess how best to use it in a highly vaccinated population. Paxlovid will be added to a Panoramic national study in England, which is making antivirals available to a wide number of patients while collecting data on how best these drugs should be used in a vaccinated adult population. 

13 April:

Pfizer CEO Albert Bourla said today that the company could potentially develop a new vaccine that protects against the Omicron variant as well as older variants of COVID-19 by autumn.  

The BA.2 Omicron subvariant of the coronavirus is responsible for 86% of US COVID-19 cases, according to new data from the US Centers for Disease Control and Prevention (CDC). It is responsible for more than 90% of infections in the US Northeast. 

The new COVID-19 subvariant Omicron XE, first found in the UK, has now been detected in Japan. Omicron XE is a recombinant variant, meaning it is a mix of two earlier Omicron strains, BA.1 and BA.2. Just over 1,000 cases have been detected in the UK so far. 

A study published by The Lancet shows all currently circulating Omicron subvariants evade neutralisation by vaccine-induced antibodies with "comparably high efficacy", suggesting that increased antibody evasion is not the reason for the sharp rise in BA.2 in several countries. Fully vaccinated people (three doses) saw the most potent antibody response. 

12 April:

The World Health Organization (WHO) says it is tracking a few dozen cases of two new sub-variants of the Omicron strain to assess whether they are more infectious or dangerous. It has added BA.4 and BA.5, sister variants of the original BA.1 Omicron variant, to its list for global monitoring. 

11 April:

Taiwan has placed an order for 700,000 units of Pfizer's COVID-19 oral antiviral pill Paxlovid as infections in the country continue to rise. Taiwan's Health Ministry said the order would cover 3% of the population, with half of the units due to arrive in the second quarter of this year. 

Japan has cancelled the purchase of around 40 million AstraZeneca COVID-19 vaccine doses it agreed to buy last year. Japan had originally agreed to buy 120 million doses, with the majority made domestically by Daiichi Sankyo Co. and other local partners. Of the doses delivered so far, about 200,000 have been supplied to local governments and 63 million donated overseas. The country has predominantly relied on mRNA vaccines produced by Pfizer and Moderna for inoculations and boosters. 

8 April:

Moderna has recalled 764,900 doses of its COVID-19 vaccine made by contract manufacturer Rovi after a vial was found to have been contaminated by a foreign body. The company says no safety issues have been identified yet and the full batch is being recalled out of an 'abundance of caution'. The impacted batch was dispersed between Norway, Poland, Portugal, Spain and Sweden in January. 

EU health agencies have said it is too early to recommend a fourth COVID-19 vaccine dose for the general population. The European Centre for Disease Prevention and Control and the EMA's COVID-19 taskforce agree that a fourth dose can be given to people aged 80 and above, but said in a joint statement that there is no clear evidence to indicate that vaccine protection against severe disease is waning substantially in adults aged 60-79. They said they will continue to monitor the situation and cautioned that a fourth dose may become necessary if the epidemiological situation changes. 

6 April:

The US FDA announced yesterday that GlaxoSmithKline and Vir Biotechnology's antibody therapy sotrovimab is no longer authorised as a COVID-19 treatment, with data suggesting it is unlikely to be effective against the Omicron sub-variant BA.2. The agency had already pulled authorisation for the therapy in much of the US northeast last month. 

COVAX, the global project to share COVID-19 vaccines, and the African Union have declined the offer to purchase additional doses of Moderna's vaccine due to issues allocating supplies. Moderna confirmed the global alliance did not exercise the option to buy 166 million doses for the third quarter of 2022, as well as 166 million for the fourth quarter. As supply increases, many developing countries have faced issues such as gaps in cold chain storage, vaccine hesitancy and lack of funds to support distribution networks. 

A new report says it will take $15 billion in grants this year and an additional $10 billion annually after that to establish and maintain an adequate toolkit to respond to COVID-19 and address future pandemic threats. The estimate was included in a paper published by the International Monetary Fund in collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI), the Global Fund and Wellcome Trust. 

4 April:

The World Health Organization has suspended UN supply of the Covaxin COVID-19 vaccine, produced by Bharat Biotech, to allow the manufacturer to upgrade facilities and address deficiencies found in an inspection. The WHO said the vaccine is effective and no safety concerns exist, but the suspension is due to outcomes of a post emergency use listing inspection that was conducted in mid-March. 

China's National Medical Products Administration has approved CanSino Biologics' clinical trial application for its mRNA COVID-19 vaccine. Pre-clinical trial results show CanSino's vaccine can induce high-titer neutralising antibody levels against multiple coronavirus variants, including the Omicron variant.

The US Food and Drug Administration has granted Priority Review for Genentech's Actemra (tocilizumab) intravenous for the treatment of COVID-19 in hospitalised adults who are receiving frequent corticosteroids and require supplemental oxygen. A decision on US FDA approval is expected in the second half of the year. 

30 March:

The US FDA has authorised a second booster dose of the two most commonly used COVID-19 vaccines for people aged 50 and older. The boosters, either Pfizer-BioNTech or Moderna, are to be administered at least four months after the previous dose. The FDA also authorised a second booster dose for younger people with compromised immune systems - Pfizer-BioNTech for those 12 and older and Moderna for those 18 and older. The US Centers for Disease Control and Prevention backed the recommendation. 

The European Medicines Agency (EMA) has launched a review of a COVID-19 booster vaccine made by Spanish pharmaceutical firm HIPRA, saying early results showed it was effective against the Omicron variant. The HIPRA vaccine, going by the brand name PHH-1V, is protein-based and designed for adults who have already received a different COVID-19 vaccine. It needs EMA approval before it can be authorised in the EU. 

28 March:

A new Israeli study shows getting a second COVID-19 booster significantly reduces the risk of dying from the virus. Senior citizens who received a second booster of Pfizer-BioNTech's COVID-19 vaccine had a 78% lower mortality rate than those who only received one. The 40-day study included more than half a million people aged between 60 and 100. It has not yet been peer-reviewed. 

25 March:

The European Medicines Agency has recommended the use of AstraZeneca's antibody medication Evusheld by some vulnerable people to avoid getting sick with COVID-19. They advise its use in people age 12 and over before potential exposure to COVID-19, to prevent future infections. It is now up to the European Commission to officially authorise the drug. Evusheld received US FDA approval in December, while the UK authorised it last week. 

Thailand has placed an order for 50,000 treatment courses of Pfizer's oral COVID-19 drug Paxlovid. The drug will be allocated to patients in high-risk groups. Thailand's Food and Drug Administration granted approval to Paxlovid in January.

23 March:

South Korea grants emergency approval for the use of Merck's COVID-19 pill for adults. The molnupiravir pill, branded as Lagevrio, is the second oral antiviral to be authorised in South Korea after Pfizer's Paxlovid. Lagevrio is only authorised for use by people 18 and older who cannot use injection medications or Paxlovid. 

Moderna announces plans to develop two new mRNA vaccines, building on the company's COVID-19 vaccine efforts. The development programs include a combination respiratory vaccine candidate (dubbed mRNA-1230) and a new program against all four of the endemic human coronaviruses (mRNA-1287). Moderna says mRNA-1230 is designed to be used as an annual booster and targets the three most significant viruses that cause respiratory diseases in adults: SARS-CoV-2, influenza and respiratory syncytial virus. The mRNA-1287 will not include the SARS-CoV-2 virus, but instead comprises HCoV-229E, HCoV-NL63, HCoV-OC43 and HCoV-HKU1, which cause 10%-30% of upper respiratory tract infections in adults. 

Pfizer's vaccine partner claims rival companies are considering patent lawsuits over the Comirnaty vaccine. Acuitas Therapeutics, Pfizer's partner on vaccine delivery tech, has sued Arbutus and Genevant Sciences, claiming they are eyeing "hundreds of millions, if not billions, of dollars in unjustified royalties" through a potential lawsuit. Acuitas says it was after the commercial success of Comirnaty that Arbutus and Genevant made the "spurious claim" that the vaccine may infringe Arbutus' patents. Arbutus and Genevant have not yet taken legal action against Pfizer for alleged infringement. 

22 March:

The US Food and Drug Administration announced plans to hold a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on April 6 to discuss considerations for future COVID-19 vaccine booster doses. Representatives from the US Centers for Disease Control and Prevention and National Institutes of Health will also participate in the meeting. The group is expected to discuss what might warrant changing the composition of COVID-19 vaccines to address specific variants, as well as the timing and populations of booster doses in the coming months. 

The Icahn School of Medicine at Mount Sinai in the US has started a Phase 1 clinical trial of an investigational egg-based COVID-19 vaccine. The vaccine contains a recombinant Newcastle disease virus that expresses the SARS-CoV-2 virus spike protein, and will be administered to healthy adults previously immunised against COVID-19. It has no adjuvants or preservatives and could possibly offer added immunity against the virus. 

21 March:

AstraZeneca announced today that Evusheld, its antibody-based medicine for the prevention and treatment of COVID-19, retains neutralising activity against Omicron coronavirus variants, including the highly contagious BA.2 sub-variant. This is the first data looking at the impact of Evusheld treatment on "cousins" of the Omicron variant following a recent global spike in cases. The study has yet to be peer reviewed. 

Ivermectin failed to curb COVID-19 hospitalisations in the largest trial of the drug to date. Researchers found the antiparasitic failed to produce better patient outcomes than in the placebo group, looking at factors including hospitalisation rate, extent of symptoms and death rate. One of the study's lead researchers said there was "no indication that Ivermectin was clinically useful" for the treatment of COVID-19. 

Moderna announces a new supply agreement with the Swiss government for seven million doses of the company's COVID-19 booster vaccine, with anticipated delivery in 2023. The agreement also includes the option of an additional seven million doses for delivery in 2023 and 2024. 

18 March:

A study published today by The Lancet explores the Omicron variant's sensitivity to neutralisation, in light of concerns that vaccines may not provide robust protection against the new variant. Researchers found "extensive, but incomplete, evasion of neutralising antibody responses," suggesting boosting with licensed vaccines may be sufficient to raise neutralising antibody titres to protective levels. 

New research, published in Med, has identified a potentially effective treatment for COVID-19 patients with Acute Respiratory Distress Syndrome (ARDS). A clinical study conducted by Irish researchers has found an anti-inflammatory protein, alpha-1 antitrypsin (AAT), reduces inflammation in ARDS patients. The trial will move on to phase 3 and could be an important addition to existing therapeutics, as ARDS treatment options are currently limited. 

16 March:

Pfizer CEO Albert Bourla announces the drugmaker is submitting data to the FDA which outlines the recommendation for a fourth dose of the vaccine it developed collaboratively with BioNTech. While the current levels of protection from the third booster reduces numbers of patients suffering from severe illness or hospitalisation, he advocates that a fourth dose would help to reduce infection.

15 March:

Four leading members of the World Trade Organisation, the U.S., EU, South Africa and India have reached an agreement on a waiver of the Trade Related Intellectual Property agreement for the production of vaccines against the COVID-19 pandemic. This would allow developing countries to permit the domestic manufacturing of vaccines without the consent of the patent holder, a crucial step forward for global vaccine equity.

7 March:

In a paper published by The Lancet today, a study conducted by the CDC into the safety of mRNA vaccines found no link between the administration of the Pfizer/BioNTech or Moderna vaccines and death. Safety data from more than 298 million doses of mRNA COVID-19 vaccine administered in the first 6 months of the US vaccination programme show that the majority of reported adverse effects (92%) were mild and short in duration.

Moderna announce plans to establish its first mRNA vaccine manufacturing site in Africa. The new site will be located in Kenya, and will enable Moderna to produce up to 500 million doses each year for the African continent. Moderna plans to invest up $500 million in this new facility which will focus on drug substance manufacturing in Africa, for the continent of Africa, and could be expanded to include fill/finish and packaging capabilities at the site. 

22 February:

Dow, Sartorius and Südpack announce new strategic partnership to support the global supply of coronavirus vaccines. Essential products manufactured by Sartorius, using Südpack polymer films made from Dow resins, support safe and effective vaccine production for global vaccine supply as part of a collaborative value chain effort.

21 February:

Over ten thousand participants from across the UK have now taken part in the NIHR-funded and supported PANORAMIC trial - the world’s largest study into new antiviral treatments against COVID-19 in community, ambulatory care.

The nationwide trial launched in December 2021 to rapidly generate evidence on which of the people suffering with COVID-19 at home and in the community are helped the most by new antiviral treatments - without needing to be treated in hospital. The trial will investigate a range of potentially ground-breaking oral antiviral drugs, which can be safely taken at home by people in at-risk groups (aged 50 or over, or 18-49 with a preexisting condition), in the early stages of infection.

The first antiviral drug currently being assessed through the platform trial is molnupiravir, which has already been shown to be safe and effective through smaller-scale trials. The study is expected to show how well molnupiravir works in a predominantly vaccinated population, as well as its cost effectiveness.

11 February:

The FDA issued an emergency use authorization (EUA) for a new monoclonal antibody for the treatment of COVID-19 that retains activity against the omicron variant. The EUA for bebtelovimab, manufactured by Eli Lilly, is for the treatment of mild to moderate COVID-19 in adults and pediatric patients with a positive COVID-19 test, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate. 

WHO adds Tocilizumab, a monoclonal antibody, to its list of prequalified treatments for COVID-19. To date, six COVID-19 treatments have been prequalified by WHO. Tocilizumab, which is manufactured by Roche and has been authorised mostly for the treatment of arthritis, is a monoclonal antibody that inhibits the Interleukin-6 (IL-6) receptor. When given intravenously, it has been shown in clinical studies to reduce death in certain patients with COVID-19 who are severely ill, rapidly deteriorating and have increasing oxygen needs. In the largest clinical trial, Tocilizumab also reduced patients’ time in hospital.      

The patent for Tocilizumab has expired for most of its uses, which means there should be no intellectual property barriers for this particular IL-6 blocker. However, Tocilizumab is in short supply globally and is an expensive product – reportedly around USD 500-600 per single dose. WHO and partners are currently discussing lower prices and improved access in low- and middle-income countries with the producer, Roche.

9 February:

Glenmark Pharmaceuticals Limited – a global, innovation-driven pharmaceutical company and Canadian pharmaceutical company SaNOtize Research & Development Corp. announce the launch of its Nitric Oxide Nasal Spray under the brand name FabiSpray® in India; for the treatment of adult patients with COVID-19 who have high risk of progression of the disease. FabiSpray®, Nitric Oxide Nasal Spray, is designed to kill the COVID-19 virus in the upper airways. It has proven anti-microbial properties with a direct virucidal effect on SARS-CoV-2. NONS when sprayed over nasal mucosa acts as a physical and chemical barrier against the virus, preventing it from incubating and spreading to the lungs.

8 February:

Model Medicines, the pharmatech company working to transform the drug discovery and development industry and accelerate the creation of life-changing drugs using artificial intelligence and machine learning, announces preclinical results demonstrating a once daily, oral dosing of MDL-001 significantly reduces the viral load of SARS-CoV-2 in the lungs of an established mouse-adapted animal model of SARS-CoV-2 infection. This indicates the potent antiviral activity of MDL-001, which may lead to faster recovery time for patients with COVID-19 while minimizing the transmission of infection, particularly in regions where vaccines and antibody therapies are not readily available

7 February:

SAHPRA, the South African Health Products Regulatory Authority, has registered two COVID-19 vaccines: the COMIRNATY vaccine by Pfizer Laboratories (Pty) Ltd on 25 January 2022, and the COVID-19 VACCINE MC PHARMA by MC Pharma (Pty) Ltd. on 31 January 2022. 

1 February:

• Cocrystal Pharma has announced the selection of two investigational antiviral drug candidates, CDI-988 and CDI-873, to further develop them as oral therapies to treat Covid-19. In-human clinical trials will begin later this year.

31 January:

• Singaporean healthcare services provider Zuellig Pharma is using a blockchain-based network to track COVID-19 vaccinations to prevent practitioners from administering expired vaccines, reports crypto news outlet, Cointelgraph.

Zuellig Pharma says that its new “eZTracker” management system can help prevent the use of improperly stored or counterfeit vaccines by allowing its clients to instantly verify the provenance and authenticity of their vaccines via a mobile app.

• Japanese trading and pharmaceuticals company Kowa Co Ltd on Monday said that anti-parasite drug ivermectin showed an "antiviral effect" against Omicron and other coronavirus variants in joint non-clinical research. The company has been working with Tokyo's Kitasato University on testing the drug as a potential treatment for COVID-19.

28 January:

• The EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation for Pfizer's oral antiviral COVID-19 treatment, Paxlovid - the first of its kind to be recommended in the EU. Paxlovid is expected to be active against both Omicron and other variants.

25 January:

• The FDA has revised authorisations for Regeneron’s REGEN-COV and Eli Lilly’s Bamlanivimab and etesevimab COVID-19 monoclonal antibody drugs, in light of new data indicating these treatments would prove ineffective against the omicron variant. Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as the COVID-19 virus, and like other infectious organisms, this can mutate over time, resulting in certain treatments not working against certain variants such as omicron. The US regulator stated that 'The FDA is committed to continuing to review emerging data on all COVID-19 therapies related to the potential impact of variants and revise the authorizations further as appropriate to ensure healthcare providers have an effective arsenal of treatments for patients.'

23 January:

• WHO Europe Director, Hans Kluge, tells news agency AFP that the Omnicron variant has moved the COVID-19 pandemic into a new phase, making it plausible that "the region is moving towards a kind of pandemic endgame." He adds that once the current surge of Omicron currently sweeping across Europe subsides, “there will be for quite some weeks and months a global immunity, either thanks to the vaccine or because people have immunity due to the infection, and also lowering seasonality.”

17 January:

• COVAX, the vaccines pillar of the WHO Access to COVID-19 Tools (ACT) Accelerator, has delivered its 1 billionth COVID-19 vaccine dose following a shipment of 1.1 million COVID-19 vaccines to Rwanda. COVAX is leading the largest vaccine procurement and supply operation in history, with deliveries to 144 countries to date.

14 January:

• WHO has recommended two new drugs - baricitinib and sotrovimab - to treat COVID-19. Baricitinib is an oral drug, used in the treatment of rheumatoid arthritis, which is strongly recommended for patients with severe or critical COVID-19. Sotrovimab is an alternative to casirivimab-imdevimab, a monoclonal antibody cocktail, for treating mild or moderate COVID-19 in patients who are at high risk of hospitalization.

12 January:

• The South Korea Ministry of Food and Drug Safety has approved a Biologics License Application (BLA) for Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) for active immunization in individuals 18 years of age and older for the prevention of COVID-19 caused by SARS-CoV-2. The joint venture between SK bioscience and Novovax is the first protein-based COVID-19 vaccine to be approved for commercial use in South Korea.

6 January:

• Reuters report that a group of International Investors representing USD 3.5 trillion in assets have called on a number of Big Pharma companies to link executives' pay to delivering vaccine equity across the globe through adopting the WHO road map. In the 'Strategy to Achieve Global COVID-19 Vaccination', the WHO have established targets for vaccinating 70% of the population of every country by mid-2022. Whilst several wealthier nations are now rolling out booster programmes for citizens, across the African continent vaccination rates average only around 10%.

3 January:

• Evotec SE has been selected by the German Federal Ministry of Education and Research (BMBF) to receive a grant for the development of EVT075, a potential first-in-class immunomodulatory therapy against COVID 19. The molecule offers the potential to amplify the immune response, and therefore reduce the risk of hospitalisation or serious disease progression.

31 December:

• The MHRA has approved Pfizer's oral COVID-19 treatment Paxlovid, after it was found to be a safe and effective at reducing the risk of hospitalisation and death in people with mild to moderate infection, and who are at an increased risk of developing severe disease.

22 December:

• Oxford University and AstraZeneca have started work on an Omicron-targeted version of their jointly developed COVID-19 vaccine, according to ta report in the Financial Times. “Like with many previous variants of concern, and together with our partners AstraZeneca, we have taken preliminary steps in producing an updated vaccine in case it is needed,” Sandy Douglas, a research group leader at Oxford, tells the newspaper. The MHRA has approved Pfizer's oral COVID-19 treatment Paxlovid, after it was found to be a safe and effective at reducing the risk of hospitalisation and death in people with mild to moderate infection, and who are at an increased risk of developing severe disease.

21 December:

• The European Commission approves a variation to the Conditional Marketing Authorization for Gilead’s antiviral Veklury (remdesivir) to include adults who do not require supplemental oxygen and are at an increased risk of progressing to severe COVID-19. This decision follows the positive recommendation of the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), to expand the indication for Veklury on December 16.

20 December:

• The European Medicines Agency recommends granting a conditional marketing authorization for Novavax' COVID-19 vaccine (NVX-CoV2373) to prevent COVID-19 in people from 18 years of age and older. If authorized, NVX-CoV2373 would be marketed in the European Union as Nuvaxovid COVID-19 Vaccine (recombinant, adjuvanted).

• Moderna says a booster dose of its COVID-19 vaccine appears to be protective against the Omicron variant of the coronavirus in laboratory testing and that the current version of the shot would continue to be its "first line of defence against Omicron,” according to a Reuters report. The company says its decision to focus on the current vaccine, mRNA-1273, was driven in part by how quickly the variant is spreading.

15 December:

• Sanofi and GlaxoSmithKline announce that preliminary results from a clinical trial show a single booster dose of their recombinant adjuvanted COVID-19 vaccine candidate delivered consistently strong immune responses. Neutralizing antibodies increased 9- to 43-fold regardless of the primary vaccine received (AstraZeneca, Johnson & Johnson, Moderna, Pfizer/BioNTech) and for all age groups tested.

• The European Medicines Agency regulator recommends that a booster dose of Johnson & Johnson’s COVID-19 vaccine may be given at least two months after a first dose in people aged 18 years and older, according to Reuters.

14 December:

• Pfizer says final results from its Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) trial of its novel COVID-19 oral antiviral candidate Paxlovid show that the pill significantly reduced the risk of hospitalization or death by 89% compared to placebo in non-hospitalized, high-risk adult patients treated within three days of symptom onset.

• CDMO Samsung Biologics expands the scope of its manufacturing collaboration with AstraZeneca to include COVID-19 and cancer therapy. Samsung is manufacturing AstraZeneca’s COVID-19 long-acting antibody (LAAB) combination, AZD7442, being developed for the prevention and treatment of COVID-19.

6 December:

• Thermo Fisher Scientific signs a deal to manufacture Merck’s oral antiviral pill for the treatment of COVID-19, molnupiravir, the latest move in the pharma firm’s effort to make the investigational treatment more widely available around the world. Molnupiravir is being developed by Merck in partnership with Ridgeback Biotherapeutics. Thermo Fisher’s manufacturing site in Whitby, Ontario, will manufacture the drug for distribution in Canada and the UK as well as markets in the European Union, Asia Pacific and Latin America, pending local market approvals.

5 December:

• Johnson & Johnson says preliminary results from an independent study, including a subset of participants from the Janssen-sponsored COV2008 study, show that a booster shot of its COVID19 vaccine (Ad26.COV2.S), administered at six months after a two-dose primary regimen of BNT162b2, increased both antibody and T-cell responses.

3 December:

• The US Food and Drug Administration expands the Emergency Use Authorization (EUA) for Eli Lilly’s bamlanivimab and etesevimab administered together to include certain high-risk pediatric patients up to 12 years old. This expansion allows for the coktail to be administered in high-risk pediatric patients for the treatment of mild to moderate COVID-19 as well as post-exposure prophylaxis.

30 November:

• Moderna CEO Stéphane Bancel predicts that existing COVID-19 vaccines will be much less effective at tackling the Omicron variant than earlier strains of coronavirus and warns it will take months before pharmaceutical companies can manufacture new variant-specific jabs at scale, according to the Financial Times. He says the high number of Omicron mutations on the spike protein, which the virus uses to infect human cells, and the rapid spread of the variant in South Africa suggest that the current crop of vaccines may need to be modified next year.

29 November:

• The World Health Organisation recommends priority actions to nations to enhance readiness and prepare response to the newly discovered and highly transmissible Omicron variant. These include ensuring early warning systems are in place, ensuring mitigation plans are in place to maintain essential health services and necessary health care resources are in place to respond to potential surges. The WHO says countries should also regularly communicate evidence-based information on Omicron and other circulating variants. “The overall risk related to Omicron is considered very high for a number of reasons. First, the global risk of COVID‐19 remains very high overall, and second, there is concerning preliminary evidence on Omicron suggesting, in contrast to previous VOCs, both potential immune escape and higher transmissibility that could lead to further surges with severe consequences,” the WHO says.

28 November:

• In a statement from the WHO, new variant B.1.1.529, now named Omicron, has been designated a variant of concern. It is not currently known whether Omicron is more transmissable than previous variants, nor if existing vaccines will prove effective against it. Researchers around the world are undergoing studies to better understand the impact of Omicron, and severity of disease.

26 November:

• The US Food and Drug Administration issues a clinical hold on Ocugen’s Investigational New Drug application to evaluate its COVID-19 vaccine candidate, BBV152, known as COVAXIN outside the US. The FDA plans to identify the specific deficiencies that are the basis for clinical hold and information on how to address those deficiencies.

24 November:

• Johnson & Johnson announces that Health Canada has granted full approval for its single-shot COVID-19 vaccine to prevent COVID-19 in adults aged 18 and over.

• GreenLight Biosciences announces a partnership agreement in which Samsung Biologics will manufacture its mRNA COVID-19 vaccine candidate at commercial scale.

23 November:

• The World Health Organization’s Europe office warns that the 53-country region could face another 700,000 deaths in the coronavirus pandemic by next spring, topping 2 million in total, citing the large numbers of unvaccinated people, the delta variant and easing of measures such as mask wearing and social distancing.

22 November:

• The European Medicines Agency says it is evaluating data on booster doses of Johnson & Johnson’s COVID-19 vaccine following an application, and a decision could come “within weeks” under a speedy review, according to Reuters.

17 November:

• The European Medicines Agency says it has started evaluating an application for conditional marketing authorisation for Novavax’s COVID-19 vaccine, Nuvaxovid (also known as NVX-CoV2373). The assessment will proceed under an accelerated timeline, and an opinion on the marketing authorisation could be issued within weeks.

16 November:

• Atea Pharmaceuticals announces that its strategic collaboration with Roche developing AT-527, an oral direct-acting antiviral (DAA) agent will be terminating. Upon termination, the rights and licenses granted by Atea to Roche under the strategic collaboration will be returned to Atea, and Atea will have full rights to continue the clinical development and future commercialization of AT-527 worldwide.

• Pfizer says it has file for Emergency Use Authorization of its oral antiviral, Paxlovid (ritonavir) for the treatment of mild to moderate COVID-19 in patients at increased risk of hospitalizations or death. The submission to the US Food and Drug Administration includes clinical data from a Phase 2/3 interim analysis. If authorized or approved, Paxlovid would be the first oral antiviral of its kind, a 3CL protease inhibitor specifically designed to combat SARS-CoV-2 that could be prescribed as an at-home treatment.

• Moderna says it has agreed to allow European Union and European Economic Area countries to donate doses of its COVID-19 vaccine that they have purchased under the EU Vaccines Strategy to COVAX on an ongoing basis for delivery in 2021. The initiative, led by France, Sweden, and Norway is expected to enable the donation of more than 70 million doses of the biotech’s vaccine in 2021, including an initial donation of 15 million doses by France and 40 million doses by Germany.

12 November:

• AstraZeneca says it will start to receive a modest profit from its COVID-19 vaccine as part of a post-pandemic commercial approach. While the company made an initial commitment to provide the vaccine at cost, it says it is moving away from this model. “The company is now expecting to progressively transition the vaccine to modest profitability as new orders are received,” the company says. “COVID-19 vaccine sales in Q4 2021 are expected to be a blend of the original pandemic agreements and new orders, with the large majority coming from pandemic agreements.”

11 November:

• The European Medicines Agency’s human medicines committee (CHMP) has recommended authorising Regeneron’s Ronapreve (casirivimab/imdevimab) and Celltrion’s Regkirona (regdanvimab) for COVID-19. The CHMP will now send its recommendations for both medicines to the European Commission for rapid legally binding decisions.

9 November:

• France’s public health authority, the Haute Autorite de Sante recommends that people under 30 take Pfizer’s Comirnaty COVID-19 vaccine instead of Moderna’s, citing a higher risk of heart-related problems in the latter, according to a Reuters report.

8 November:

• Zydus Cadila says it has received an order to supply 10 million doses of ZyCoV-D, its Plasmid DNA Vaccine, to the Indian government at Rupee 265 ($3.57) per dose and the needle-free applicator being offered at Rupee 93 ($1.25) per dose, excluding Goods and Services Tax.

• Regeneron Pharmaceuticals says that in a Phase 3 trial, a single dose of its investigational REGEN-COV (casirivimab and imdevimab) antibody cocktail reduced the risk of contracting COVID-19 by 81.6% during the pre-specified follow-up period (months 2-8), maintaining the 81.4% risk reduction during the first month after administration, which was previously reported in The New England Journal of Medicine.

4 November:

• Novavax says it has completed its rolling submission to the World Health Organization for emergency use listing (EUL) of NVX-CoV2373, its COVID-19 vaccine candidate.

• Announcing its third quarter financial results, Moderna says FY 2021 deliveries of its COVID-19 vaccine are likely to be between 700 million and 800 million doses at the 100 µg dose level. “Key variables impacting output include longer delivery lead times for international shipments and exports that may shift deliveries to early 2022, temporary impact from expansion of fill/finish capacity and ramp up of product release to market,” the company says.

• Merck & Co and Ridgeback Biotherapeutics announce that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted authorization  their antiviral pill, molnupiravir, for the treatment of mild-to-moderate COVID-19 in adults who have tested positive. The planned trademark for molnupiravir in the UK is Lagevrio.

3 November:

• The World Health Organization issues an emergency use listing for Bharat Biotech’s COIVD-19 vaccine, Covaxin. The vaccine is formulated from an inactivated SARS-CoV-2 antigen and is presented in single dose vials and multidose vials of 5, 10 and 20 doses.

• The US CDC gives the green light to Pfizer-BioNTech’s COVID-19 vaccine for children 5 to 11 years old, expanding vaccine recommendations to about 28 million children in the US in this age group.

2 November:

• Eli Lilly says it will supply the US government with 614,000 doses of bamlanivimab with etesevimab authorised for emergency use for the treatment of mild to moderate COVID-19 no later than January 31, 2022 for a total of $1.29 billion. A minimum of 400,000 doses will be supplied no later than December 31, 2021.

1 November:

• Novavax and Serum Institute of India announce that Indonesia has granted emergency use authorization (EUA) for their recombinant nanoparticle protein-based COVID-19 vaccine. It will be manufactured by SII in India and marketed by SII in Indonesia under the brand name Covovax.

31 October:

• Moderna says it has been notified by the US Food and Drug Administration that the regulator will require additional time to complete its assessment of Moderna’s Emergency Use Authorization (EUA) request for its COVID-19 vaccine (mRNA-1273) at the 100 µg dose level in adolescents 12 to 17 years of age.

27 October:

• Novavax says it has completed its rolling regulatory submission to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for authorization of its COVID-19 vaccine. The company’s application for Conditional Marketing Authorization (CMA) marks the first submission for authorization of a protein-based COVID-19 vaccine in the country.

26 October:

• The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee votes to recommend that the FDA grant Emergency Use Authorization for the Pfizer/BioNTech’s COVID-19 vaccine in children 5 to <12 years of age. VRBPAC is made up of independent experts who advise the FDA on scientific and regulatory matters, including the evaluation of vaccine safety and efficacy.

• BioNTech announces it will build a state-of-the-art manufacturing site for mRNA-based vaccines in the Africa in mid-2022. While the company has not yet announced the location of the site, it said it had signed a memorandum of understanding with the Rwandan government.

• Moderna said it has signed a deal to make up to 110 million doses of its COVID-19 vaccine available to the African Union. The company is prepared to deliver the first 15 million doses in Q4 2021, 35 million doses in Q1 2022, and up to 60 million doses in Q2 2022. All doses are offered at Moderna’s lowest tiered price.

25 October:

• The European Medicines Agency starts a rolling review for molnupiravir, Merck & Co’s investigational oral antiviral medicine, for the treatment of COVID-19 in adults.

21 October:

• Novartis announces that it has signed an initial agreement to use its sterile manufacturing facilities at its site in Ljubljana, Slovenia, to fill at least 24 million doses of Pfizer/BioNTech’s COVID-19 vaccine in 2022. Under the terms of the deal, Novartis plans to take bulk mRNA active ingredient from BioNTech and fill this into vials under sterile conditions for shipment back to BioNTech for distribution. Subject to reaching a final agreement, Novartis plans to transfer the manufacturing process from its Stein site in Switzerland to Ljubljana site to start the fill and finish in the first half of 2022.

20 October:

• Novavax defends its manufacturing processes after a recent report which claimed the company was struggling to meet US Food and Drug Administration quality standards in the production of its COVID-19 vaccine. According to the report on news website Politico, which cited anonymous sources, the company has failed to produce a vaccine with purity levels required by the US regulatory agency. “Since March 2020, Novavax has worked diligently, methodically and transparently to develop our novel COVID-19 vaccine candidate, taking on the challenge of developing and producing at large scale a proven biologic-based vaccine amid unprecedented circumstances,” the company says in a statement.

19 October:

• Novavax announces that data from a Phase 2 clinical study conducted by the University of Oxford shows that its recombinant nanoparticle protein-based COVID-19 vaccine candidate, NVX-CoV2373, remains effective when given as the second dose in a mixed, or heterologous, regimen after either the Oxford/Astra Zeneca or Pfizer/BioNTech vaccines as the first dose.

18 October:

• Thermo Fisher Scientific says it has received Emergency Use Authorization (EUA) from the US Food and Drug Administration to run COVID-19 tests from saliva samples collected with the Spectrum Solutions SpectrumDNA SDNA-1000 collection device on the Amplitude Solution. SDNA saliva collection devices are self-contained systems that provide sample consistency and long-term stability while protecting DNA and RNA transcripts post-collection to help ensure accurate test results with just two milliliters of saliva. The Amplitude Solution gives laboratories the ability to scale COVID-19 PCR testing and process up to 8,000 samples in a single day.

• Valneva says results from a Phase 3 trial in the UK of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001 show it “demonstrated superiority” against AstraZeneca’s vaccine in terms of geometric mean titer for neutralization antibodies, as well as non-inferiority in terms of seroconversion rates (SCR above 95% in both treatment groups) at two weeks after the second vaccination (i.e. Day 43) in adults aged 30 years and older.

• The World Health Organization says India’s Bharat Biotech needs to submit more data before it can consider the company’s request for an emergency-use listing for its COVID-19 shot, saying the WHO could not “cut corners” in making a decision, according to Reuters. The vaccine was given an EUA in India in January before a late-stage trial was completed, which later found the shot to be 78% efficacious.

15 October:

• A US Food and Drug Administration advisory committee unanimously decides to grant emergency use approval for a second dose of Johnson & Johnson’s COVID-19 vaccine for adults, at least two months after the first dose.

• Bayer and CureVac end a manufacturing partnership for the latter’s COVID-19 vaccine, after disappointing trial results. A Bayer spokesman tells German newspaper Rheinische Post that the companies “have decided by mutual agreement to not continue cooperation.”

12 October:

• India’s Everest Organics starts manufacturing the active pharmaceutical ingredient for Merck & Co’s investigational antiviral pill, molnupiravir, to treat mild to moderate COVID-19, the API manufacturer said in a filing to the Bombay Stock Exchange.

• Australia’s CSL says it is mandating COVID-19 vaccinations for its entire workforce. “We have extended this mandate to all those at our Australian sites, and we intend to do the same at our US operations in keeping with requirements set by the US government,” says CEO Brian McNamee.

11 October:

• Merck & Co submits an Emergency Use Authorisation application to the US Food and Drug Administration for its oral antiviral, molnupiravir, to treat mild to moderate COVID-19.

8 October:

• Indian companies, Aurobindo Pharma and MSN Laboratories ask for permission to end late-stage trials of their generic versions of Merck & Co’s experimental antiviral, molnupiravir, to treat moderate COVID-19, according to Reuters.

5 October:

• The European Medicines Agency authorizes a third dose of Moderna’s COVID-19 vaccine (Spikevax) given at least 28 days after the second dose to severely immunocompromised individuals 12 years of age or older. “It is promising to see recent trials demonstrating that a third dose of the Moderna COVID-19 vaccine may enhance immune response in this important population,” says Moderna CEO, Stéphane Bancel.

• Johnson & Johnson says it has submitted data to the US Food and Drug Administration to support use of a second booster shot of its COVID-19 vaccine in adults. The submission includes recent results from a Phase 3 ENSEMBLE 2 study that found a booster of the vaccine given 56 days after the first dose provided 94% protection against moderate to severe/critical COVID-19 in the US and 100% protection against severe/critical COVID-19, at least 14 days post-booster vaccination.

• AstraZeneca submits a request to the US Food and Drug Administration for an Emergency Use Authorization for AZD7442, its long-acting antibody combination, for prophylaxis of symptomatic COVID-19. If granted, AZD7442 would be the first LAAB to receive an EUA for COVID-19 prevention.

4 October:

• The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issues a positive opinion on the administration of Pfizer and BioNTech’s COVID-19 vaccine as a booster dose at least six months after the second dose in adults. The European Commission will review the CHMP recommendation and is expected to make a final decision on a variation to the Conditional Marketing Authorization in the near future.

1 October:

• Merck & Co and Ridgeback Biotherapeutics announced that their investigational antiviral pill, molnupiravir (MK-4482, EIDD-2801) significantly reduced the risk of hospitalization or death at a planned interim analysis of the Phase 3 MOVe-OUT trial in at risk, non-hospitalized adult patients with mild-to-moderate COVID-19. Recruitment into the study is being stopped early due to the positive results and Merck plans to submit an application for Emergency Use Authorization to the US Food and Drug Administration as soon as possible.

29 September:

• Dr. Anthony Fauci warns that the US Food and Drug Administration’s decision on whether to approve Pfizer and BioNTech’s COVID-19 vaccine for children ages 5 to 11 may not arrive until November, according to Reuters.

• Bloomberg reports that the US Food and Drug Administration is considering an authorization of half-dose booster shots of Moderna’s COVID-19 vaccine, a move which would allow the company to ramp up its production of doses as well as widen the US booster campaign.

28 September:

• Sanofi says it has decided not to pursue the development of its COVID-19 mRNA candidate into a Phase 3 clinical study and will focus on completing the final development steps of its COVID-19 recombinant vaccine, developed in partnership with GSK. The company says it will focus its mRNA resources in its newly created mRNA Center of Excellence to address future pandemics and other infectious diseases and therapeutics.

• Pfizer and BioNTech announce they have submitted data to the US Food and Drug Administration from the Phase 2/3 trial of their COVID-19 vaccine in children 5 to <12 years of age.

24 September:

• BD says a preliminary study investigating the impact of deep cold storage on glass PFS showed key product functions – PFS system level – were unaltered when stored at -20°C and -40°C, showing its suitability for storage of mRNA vaccines against COVID-19. In addition, the count of subvisible particles and container closure integrity (CCI) remained unchanged when compared to those stored at room temperature.

23 September:

• In a new report, A Double Dose of Inequality: Pharma companies and the Covid-19 vaccines crisis, Amnesty International accuses big pharma of fuelling a human rights crisis over vaccine supply to the world's poorer countries. The report targets AstraZeneca, BioNTech, Johnson & Johnson, Moderna, Novavax and Pfizer for prioritising profits over patients, and refusing to participate in initiatives to boost global vaccine supply. The report highlights that fewer than 1% of people in low-income countries are fully vaccinated, compared to 55% in rich countries.

22 September:
 • The Korean Biomedical Review reports that domestic drugmakers Daewoong Pharmaceutical, Shinpoong Pharm, GeneOne Life Science have been conducting studies into repurposing their existing Covid therapies as oral treatments. While no oral Covid therapies have been approved in Korea to date, the Government is monitoring the situation and has set aside 36.2 billion won ($30.7 million) to buy oral Covid-19 treatments into next year. Oral treatments are more costly to produce, but are easier and more convenient to adminster. Oral therapies are garnering interest due to the concern that vaccines may only have a limited window of efficacy.

20 September:

• Pfizer and BioNTech announce positive topline results from pivotal trial of COVID-19 vaccine in children aged 5 to 11 Years. Read the statement in full here. Albert Bourla, Chairman and Chief Executive Officer, Pfizer says: “over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine. We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children.”

15 September:

• Eli Lilly and Company announce an additional purchase by the U.S. government for its neutralizing antibody therapies authorized for emergency use as a treatment for COVID-19. Lilly will supply 388,000 doses of etesevimab to complement doses of bamlanivimab previously purchased by the U.S. government, with approximately 200,000 doses expected to ship Q3 2021 and the remaining to be shipped in Q4. Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific and medical officer, and president of Lilly Research Laboratories commented: "The recent increase in COVID-19 cases has caused a substantial rise in the utilization of monoclonal antibody drugs, particularly in areas of the country with low vaccination rates. Lilly developed bamlanivimab and etesevimab for administration together, in anticipation of variants such as the highly contagious Delta variant, which currently accounts for more than 98 percent of all identified COVID-19 cases in the U.S."

14 September:

• The Joint Committee on Vaccination and Immunisation (JCVI) had advised that over-50s in the UK should receive a Covid Vaccine booster to 'help maintain protection against Covid-19 and new variants'. The BBC writes today that 'the NHS has been given the green light to start planning a COVID vaccine booster programme in the UK ahead of this winter.'

10 September:

• China’s Sinovac Biotech is in discussions about setting up a vaccine manufacturing facility in South Africa to supply the African continent with shots against a range of diseases including COVID-19, according to Reuters.

9 September:

• Moderna announces it is developing a two-in-one vaccine booster shot against both COVID-19 and flu. The new vaccine, which the company is calling mRNA-1073, combines Moderna’s current COVID-19 vaccine with a flu shot that’s also under development. “Today we are announcing the first step in our novel respiratory vaccine program with the development of a single dose vaccine that combines a booster against COVID-19 and a booster against flu,” says CEO Stephane Bancel. “We are making progress on enrolling patients in our rare disease programs, and we are fully enrolled in our personalized cancer vaccine trial. We believe this is just the beginning of a new age of information-based medicines.”

8 September:

• Moderna signs up CDMO National Resilience to manufacture drug substance for its mRNA COVID-19 vaccine. Under the terms of the multi-year agreement, Resilience will produce mRNA for the vaccine at its facility in Mississauga, Ontario in Canada, for distribution worldwide.

• Johnson & Johnson is in talks with the South African government about running a booster trial in the country after the company’s COVID-19 vaccine was used in a mass trial of almost half a million health workers, according to Bloomberg. The trial would include participants from the Sisonke study, and could start as early as October.

7 September:

• The Japanese Ministry of Health will purchase 150 million doses of Novavax’s COVID-19 vaccine candidate (TAK-019 in Japan) manufactured in the country by Takeda subject to licensing and approval. The details of the terms and conditions of the agreement are confidential. As part of a previously announced agreement with Novavax, Takeda is establishing the capability to manufacture TAK-019 (known outside Japan as NVX-CoV2373) at its facilities in Japan and aims to begin distribution in early calendar year 2022.

6 September

• The European Medicines Agency says it has started evaluating an application for the use of a booster dose of Pfizer/BioNTech’s Comirnaty vaccine to be given six months after the second dose in people aged 16 years and older. Booster doses are given to vaccinated people to restore protection after it has waned. EMA’s human medicines committee (CHMP) will carry out an accelerated assessment of data, including results from an ongoing clinical trial in which around 300 adults with healthy immune systems received a booster dose approximately 6 months after the second dose. The CHMP will recommend whether updates to the product information are appropriate and the outcome is expected within the next few weeks.

3 September:

• The European Medicines Agency’s safety committee (PRAC) is assessing whether there is a risk of multisystem inflammatory syndrome with COVID-19 vaccines following a report of MIS with Pfizer/BioNTech’s Comirnaty. The case occurred in a 17-year old male in Denmark who has since fully recovered. Some cases of MIS were also reported in the EEA following vaccination with other COVID-19 vaccines. The Danish patient had no history of COVID-19.

• AstraZeneca and the European Commission reach an agreement that ends legal proceedings over the execution of the Advance Purchase Agreement for the delivery of the company’s COVID-19 vaccine Vaxzevria. Under the agreement, AstraZeneca will deliver 60 million doses by the end of the third quarter 2021, 75 million by the end of the fourth quarter 2021 and 65 million by the end of the first quarter 2022. EU Member States will be provided with regular delivery schedules, and capped rebates will apply in the event of any delayed doses.

2 September:

• The US Department of Health opens up the Emergency Use Authorisation for Eli Lilly’s monoclonal antibody combination treatment of bamlanivimab and etesevimab against COVID-19 to all US states, territories, and jurisdictions. Previously, the revised EUA was limited to states in which recent data showed the combined frequency of variants resistant to bamlanivimab and etesevimab administered together was less than or equal to 5%. The increase in prevalence of the Delta variant has been associated with a decrease at the same time in the frequency of identified variants that were resistant to bamlanivimab and etesevimab, the Department says.

• New research from the University of Virginia School of Medicine finds that antibody levels in recipients of the Moderna COVID-19 vaccine were slightly higher than in recipients of the Pfizer/BioNTech jab. The difference was mostly accounted for by antibody levels in relatively older subjects. The researchers caution against drawing conclusions about the vaccines’ effectiveness based on the antibody numbers. “The thing that will be interesting is figuring out if measuring antibody levels ends up being a good marker of vaccine protection,” says UVA immunologist Jeffrey Wilson. “At the moment, we don’t know for sure.”

• Canada will donate more than 1.3 million doses of the AstraZeneca-Oxford COVID-19 vaccine to three African countries through the COVAX vaccine-sharing facility, says the Global Alliance for Vaccines and Immunization. The first shipments to Nigeria, Kenya and Niger are due to arrive on September 2. The COVAX facility, backed by the World Health Organization and GAVI, is aiming to secure two billion vaccine doses for lower income countries by the end of this year.

1 September:

• Moderna announces it has asked the US Food and Drug Administration (FDA) to evaluate a booster dose of its COVID-19 vaccine (mRNA-1273) at the 50 µg dose level. The company expects to submit data to the European Medicines Agency (EMA) and other regulatory authorities around the world in the coming days.

30 August:

• Two prefectures in Japan, Gunma and Okinawa issue temporary holds on Moderna’s COVID-19 shot after foreign substances were found in more batches of the shot, according to Reuters. Japan health ministry says the incidents may have been down to incorrect insertion of needles into vials, causing pieces of the rubber stopper to break off. The government says no safety or efficacy issues have been identified.

• The US National Institutes of Health says it has begun a Phase 2 clinical trial to assess the antibody response to an extra dose of an authorized or approved COVID-19 vaccine (Pfizer-BioNTech or Moderna) in people with autoimmune disease who did not respond to an original COVID-19 vaccine regimen. The trial will also investigate whether pausing immunosuppressive therapy for autoimmune disease improves the antibody response to an extra dose of a COVID-19 vaccine in this population. The Phase 2 trial is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, and is being conducted by the NIAID-funded Autoimmunity Centers of Excellence.

27 August:

• Spain’s Laboratorios Farmacéuticos ROVI, which is providing fill and finish for doses of Moderna’s mRNA vaccine says it is currently investigating the finding of particulate matter in certain drug product vials of the vaccine that have been distributed in Japan. “The detection of this particulate matter refers to certain vials of one product lot distributed exclusively in Japan,” the CDMO says. “ROVI, as well as Moderna and Takeda, the company distributing the referred vaccine in Japan, are working with health authorities in order to clarify and solve, if applicable, this incident. The origin of this manufacturing incident may be in one of ROVI’s manufacturing lines. ROVI is working in order to provide with all the information and assistance that may be needed to progress with the investigation.” The company adds that as a precaution, this lot and two adjacent lots have been put on hold.

26 August:

• Pfizer and BioNTech sign a letter of intent with Brazilian company Eurofarma Laboratórios to manufacture their COVID-19 vaccine, Comirnaty, for exclusive distribution within Latin America. Technical transfer, on-site development, and equipment installation activities will begin immediately. Per the agreement, Eurofarma will obtain drug product from facilities in the US, and manufacturing of finished doses will start in 2022. At full operational capacity, annual production is expected to exceed 100 million finished doses annually.

• BD announces that the US Food and Drug Administration has issued an Emergency Use Authorization for its Veritor at-home COVID-19 test — the first at-home COVID-19 rapid antigen test to use computer vision technology in a smartphone to interpret and provide a digital display of testing results. The test does not require a prescription, a laboratory or a long wait for results. The test will initially be made available to businesses, schools and governments looking to provide a self-testing option for employees or students.

25 August:

• The Japanese government suspends use of 1.63 million doses of Moderna’s COVID-19 vaccine after reports of contaminants in some vials. “Moderna confirms having been notified of cases of particulate matter being seen in drug product vials of its COVID-19 vaccine,” the biotech says in a statement. “The company is investigating the reports and remains committed to working expeditiously with its partner, Takeda, and regulators to address this.”

24 August:

• Johnson & Johnson says new interim data from two Phase 1/2a studies in individuals previously vaccinated with its single-shot vaccine demonstrate that a booster dose generated a rapid and robust nine-fold increase in spike-binding antibodies than 28 days after the first single-dose vaccination.

• Brii Biosciences announces that in the Phase 3 ACTIV-2 trial, its SARS-CoV-2 neutralizing monoclonal antibody combination therapy, BRII-196/BRII-198, reduced the risk of hospitalisation and death in high-risk outpatients by 78%. The company says that additional subgroup analysis may further delineate the clinical benefits of early (≤5 days) versus late (6-10 days) treatment with BRII-196/BRII-198 following symptom onset.

• The European Medicines Agency’s human medicines committee (CHMP) says it has approved an additional manufacturing site for the production of Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer. The site in Saint Rémy sur Avre, France, is operated by Delpharm and will manufacture finished product, providing approximately up to 51 million additional doses in 2021. The EMA has also approved a new manufacturing line at BioNTech’s manufacturing site in Marburg, Germany which increases the active substance manufacturing capacity by approximately 410 million doses in 2021. The CHMP has also approved Catalent’s Bloomington, Indiana site for finished product manufacturing for Spikevax, the COVID-19 vaccine developed by Moderna.

• The Indian government says that interim data from a Phase I trial demonstrated that the nation’s first mRNA-based COVID-19 vaccine being developed by Pune-based biotech, Gennova Biopharmaceuticals, was safe, tolerable, and immunogenic in the participants of the study.

23 August:

• The US Food and Drug Administration grants full approval to the Pfizer-BioNTech COVID-19 Vaccine, which will now be marketed as Comirnaty for adults 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

20 August:

• Moderna says it will require COVID-19 vaccination for all workers in the US, effective October 1, 2021. Requests for medical or religious exemptions will be considered on an individual basis. All Moderna workers are still required to follow local health authority and Moderna health and safety protocols when on-site.

• Roche’s Genentech says that an unprecedented surge in worldwide demand and supply constraints driven by Delta variant spikes in much of the rest of the world that preceded the current situation in the US, has led to a global shortage of its arthritis drug, Actemra (tocilizumab), which is also used to treat severely ill COVID-19 patients, for at least the next several weeks. “This new wave of the pandemic has led to Genentech experiencing an unprecedented demand for Actemra IV-- well-over 400% of pre-COVID levels over the last two weeks alone and it continues to increase,” the company says, adding that it expects to receive scheduled replenishments by the end of August.

17 August:

• Gritstone bio announces that it has entered into a funding agreement of up to $20.6 million with the Coalition for Epidemic Preparedness Innovations (CEPI) to advance the development of the biotech’s CORAL COVID-19 vaccine program with an initial focus in South Africa.

• UK regulator, the Medicines and Healthcare products Regulatory Agency approves Moderna’s COVID-19 vaccine, also known as Spikevax, for use in children aged 12 to 17 years. The shot was recommended for use in adolescents by European regulators in July and is awaiting US authorisation.

16 August:

• Pfizer and BioNTech announce they have submitted Phase 1 data to the US Food and Drug Administration to support the evaluation of a third booster dose of their COVID-19 vaccine (BNT162b2) for future licensure. The data will also be submitted to the European Medicines Agency and other regulatory authorities in the coming weeks.

• HDT Bio announces an agreement with Korean biotech Quratis to co-develop HDT’s mRNA COVID-19 vaccine for distribution in South Korea and neighboring countries. HDT previously established a collaboration with Gennova Biopharmaceuticals in India, and says it plans to announce similar deals in China and Brazil soon.

• Thermo Fisher Scientific is granted emergency use authorization from the US Food and Drug Administration for its TaqPath COVID-19 Fast PCR Combo Kit 2.0 and TaqPath COVID-19 RNase P Combo Kit 2.0, both highly accurate assays designed with increased target redundancy to compensate for current mutations and emerging SARS-CoV-2 variants. The design of both PCR-based kits have been updated from the original TaqPath assays, targeting eight different genes across three regions of the virus that causes COVID-19.

• All healthcare workers in New York State, including staff at hospitals and long-term care facilities, including nursing homes and adult care, will be required to be vaccinated against COVID-19 by September 27, Governor Andrew Cuomo announces. The State Department of Health will issue Section 16 Orders requiring all hospital, LTCF, and nursing homes to develop and implement a policy mandating employee vaccinations, with limited exceptions for those with religious or medical reasons.

• CureVac and GlaxoSmithKline’s next generation mRNA vaccine elicited strongly improved immune responses in preclinical trials compared to CureVac’s first-generation mRNA shot, CVnCoV, the companies say. Higher antibody neutralizing capacity was observed with CV2CoV across all selected variants, including the Beta, Delta and Lambda variants. During challenge with the original SARS-CoV-2 virus, animals vaccinated with CV2CoV were found to be better protected based on highly effective clearance of the virus in the lungs and nasal passages.

13 August:

• Merck announces the start of a rolling submission to Health Canada for its investigational twice daily oral antiviral agent, molnupiravir, currently in trials as a potential treatment for COVID-19. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics.

12 August:

• The US Food and Drug Administration amends the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine to allow for the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

11 August:

• CDMO Fujifilm Diosynth Biotechnologies confirms it is not responsible for manufacturing delays hampering Novavax’s recombinant nanoparticle COVID-19 vaccine candidate. Submission for Emergency Use Authorization (EUA) in the US is now expected to occur in the fourth quarter of this year due to additional required analytical work.

10 August:

• The US National Institutes of Health launches a pilot study to assess the antibody response to a third dose of an authorized COVID-19 mRNA vaccine in kidney transplant recipients who did not respond to two doses of the Moderna or Pfizer-BioNTech COVID-19 vaccine. The pilot study also aims to identify characteristics that could help distinguish those kidney transplant recipients who would benefit from a third dose of an mRNA vaccine from those who will require a different approach to achieve protection. The Phase 2 trial is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

• Moderna says it has signed a Memorandum of Understanding with the Canadian government to build a state-of-the-art vaccine manufacturing facility in Canada. The company says the agreement will not only serve to support Canada with direct access to rapid pandemic response capabilities, but will also provide Canadians with access to its vaccines in development for respiratory viruses including COVID-19, seasonal influenza, respiratory syncytial virus and potential other vaccines, pending licensure.

• Ginkgo Bioworks announces that through its collaboration with Aldevron, it is now able to produce over 10 times more of the vaccinia capping enzyme (VCE) – a critical component for mRNA vaccines - per batch than the previous process. Aldevron has the exclusive rights to the protocol conditions for this newly developed manufacturing process.

9 August:

• Gilead Sciences announces that it will require all employees and contractors to be fully vaccinated against COVID-19 as of October 1, 2021, where allowed by law and where vaccine supply is readily available. This includes all US employees. The company says that by requiring vaccines, its goals are to safeguard the health of its workforce and to protect patients and communities. “This requirement also allows us to take a critically important step to protect our workplaces, helping to ensure the seamless delivery of our medicines for patients in need,” the company adds.

• BioNTech says that along with partner Pfizer, it expects annual manufacturing capacity for their COVID-19 vaccine to reach 3 billion doses by the end of 2021 and to have capacity to manufacture up to 4 billion doses in 2022.

• South Korea's health minister Kwon Deok-cheol says that due to production issues, Moderna would deliver to the country less than half its planned shipment of 8.5 million doses in August, according to a Reuters report.

4 August:

• Pfizer says it will require all its US employees and contractors to get vaccinated against COVID-19 or participate in regular weekly testing. The new initiative will “best protect the health and safety of our colleagues and the communities we serve,” Pfizer says in a statement.

30 July:

• Russia’s sovereign wealth fund, the Russian Direct Investment Fund says the world’s first study of a combination between the AstraZeneca vaccine and the first component of the Sputnik V vaccine (Sputnik Light) in Azerbaijan shows no serious adverse events or COVID infection cases following vaccination.

• The Serum Institute of India announces a partnership with industry organisation Confederation of Indian Industry to expand the reach of COVID-19 shots in India’s countryside as it has "plenty of supply" of AstraZeneca’s vaccine, according to a Reuters report. While around 452 million doses have been administered in India, the pace of inoculations in rural areas, where two-thirds of India's 1.35 billion people live, has lagged behind that of urban centres.

29 July:

• CDMO Emergent BioSolutions says it aims to resume COVID-19 vaccine production for Johnson & Johnson at its Baltimore plant after the Food and Drug Administration approved the move. “We are proud to be resuming production of bulk COVID-19 vaccine batches following additional reviews and collaboration with FDA and our manufacturing partners,” says Emergent CEO Robert Kramer in a statement.

28 July:

• Johnson & Johnson confirms the US Food and Drug Administration has extended the shelf life for its single-shot COVID-19 vaccine to six months. The decision is based on data from ongoing stability assessment studies, which demonstrated the vaccine is stable at six months when refrigerated at temperatures of 36 – 46 degrees Fahrenheit (2 – 8 degrees Celsius). Expiration dates will be updated on www.vaxcheck.jnj, where vaccine providers can confirm the latest expiration dates of J&J’s vaccine.

• GlaxoSmithKline and Vir Biotechnology announce they have signed a deal with the European Commission to supply up to 220,000 doses of sotrovimab, an investigational single dose monoclonal antibody for the treatment of COVID-19. The agreement enables participating EU Member States to quickly purchase sotrovimab, following local emergency authorisation or authorisation at the EU level.

27 July:

• South Korean health officials say that Moderna has delayed its late-July vaccine shipment schedule for the country to August due to supply problems, according to a Reuters report. “We are currently not reserving safety stock to allow vaccines to be delivered faster, which means that we do not have stock in storage to smooth these types of shortfalls or delays,” a Moderna spokesperson says.

26 July:

• Aspen confirms that the first supplies to South Africa of the Johnson & Johnson COVID-19 vaccines, from the new API source located in Europe, have been delivered from its Gqeberha-based manufacturing site. These vaccines will be further distributed throughout South Africa in line with the various distribution arrangements between Johnson & Johnson, the National Department of Health and other stakeholders. They are the first COVID-19 vaccines to be produced on the African continent, by an African producer for South African and African patients. Supplies will also be made to the European Union and other offshore markets.

23 July:

• Pfizer and BioNTech SE announce that the US government has purchased an additional 200 million doses of their COVID-19 vaccine. The doses are expected to be delivered from October 2021 through April 2022, bringing the total number of doses to be supplied by the companies to the US under its existing supply agreement to 500 million.

• Moderna announces that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for its COVID-19 vaccine (Spikevax) to include children 12 years of age and older.

19 July:

• The European Medicines Agency says it has started evaluating the use of arthritis drug, Kineret in adult COVID-19 patients at increased risk of severe respiratory failure. Kineret’s active substance, anakinra, blocks the activity of interleukin 1, a chemical messenger involved in immune processes that lead to inflammation. It is thought that this could also help reduce the inflammation and tissue damage associated with COVID-19. EMA’s human medicines committee (CHMP) will assess data submitted in the application, including results from two ongoing clinical studies.

16 July:

• Gavi the vaccine alliance says African Union Member States are set to receive approximately 25 million of US-donated COVID-19 vaccines, contributing to the AU target of vaccinating at least 60% of the African population. The first shipments, planned for the coming days, will see nearly a million doses of the Johnson & Johnson vaccine delivered to Burkina Faso, Djibouti, and Ethiopia.

15 July:

• Canadian Prime Minister Justin Trudeau says that if the country’s current positive path of vaccination rate and public health conditions continue, it will be in a position to open its borders to fully vaccinated travellers from all countries by early September. Around 80% of eligible Canadians have received a first dose and over 50% are fully vaccinated.

14 July:

• An official at the Thai government says the country is considering a limit on exports of locally manufactured AstraZeneca COVID-19 vaccines due to mounting domestic cases of the disease.

• Australian biotech ENA Respiratory announces it has started a Phase I study of its INNA-051 nasal spray for the prevention of COVID-19 and other respiratory viral infections.

• The Italian health ministry says it has granted GlaxoSmithKline and Vir Biotechnology approval to temporarily distribute their coronavirus antibody treatment, sotrovimab, within the country until January 31, 2022.

13 July:

• World Health Organisation director-general Ngozi Okonjo-Iweala says the COVAX vaccine-sharing programme is facing challenges to meet vaccine delivery targets because it is being outbid by some countries amid scant supply, according to Reuters. “Many of them supported COVAX but many of them bid away vaccines from COVAX and that is why COVAX has been struggling to deliver what it should,” she says.

• Announcing new COVID-19 rules, French President Emmanuel Macron says all health workers in France must receive COVID-19 shots and anyone wanting to gain entrance to cinemas or board trains will need to show proof of vaccination or a negative test.

• The World Health Organisation’s chief scientist Dr Soumya Swaminathan warns a news briefing that mixing and matching COVID-19 vaccines by individuals is “a little bit of a dangerous trend here.” Such decisions should be taken by public health authorities, she adds.

12 July:

• The rollout of the Sputnik V COVID-19 vaccine in India has been paused until the Russian producer provides equal quantities of its two differing doses, the vaccine’s distributor in the country, Dr. Reddy’s Laboratories tells Reuters. Dr. Reddy’s received about 3 million first doses by June 1 and about 360,000 doses of the second by early this month, the company and the Indian government have said. “As a matter of responsibility, we would not like to announce a full-fledged commercial launch until we have an equivalent quantity (of the second dose),” Dr. Reddy’s says.

• Gavi, the Vaccine Alliance announces it has signed advance purchase agreements with Sinopharm’s and Sinovac’s respective COVID-19 vaccines. The agreements, which come at a time when the Delta variant is posing a rising risk to health systems, will begin to make 110 million doses immediately available to participants of the COVAX Facility, with options for additional doses. Gavi will buy 60 million doses for July through October 2021 and has the option for a further 60 million doses in Q4 2021 and 50 million more doses in the first half of 2022.

• Italian biotech ReiThera says a Phase II study found its experimental COVID-19 vaccine induced antibody responses against the SARS-CoV-2 spike protein in over 93% of volunteers at three weeks after the first dose, reaching 99% after the second dose. Five weeks after the first vaccination, the titer of both spike-binding and SARS-CoV-2 neutralizing antibodies was comparable to that measured in a reference group of patients recovering from COVID-19 infection.

9 July:

• Humanigen says its submission for UK marketing authorization for lenzilumab in COVID-19, begun in June 2021, has been accepted by the country’s Medicines and Healthcare Products Regulatory Agency for expedited COVID-related rolling review.

• The World Health Organization says it is not clear whether COVID-19 booster vaccines will be needed to maintain protection, until further data is collected, after Pfizer said it plans to seek US regulatory approval for a booster dose of its COVID-19 vaccine within the next month. “We don’t know whether booster vaccines will be needed to maintain protection against COVID-19 until additional data is collected, but the question is under consideration by researchers,” the WHO tells Reuters.

• The European Medicines Agency concludes that myocarditis and pericarditis can occur in very rare cases following vaccination with Pfizer/BioNTech’s and Moderna’s COVID-9 vaccines. The agency is recommending listing these inflammatory heart conditions as new side effects in the product information for these vaccines, together with a warning to raise awareness among healthcare professionals and people taking them.

8 July:

• Sanofi and GlaxoSmithKline say they have received approval for their Phase III clinical study in India, to assess the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate. The study will include more than 35,000 volunteers aged 18 and older across sites in the US, Asia, Africa, and Latin America.

7 July:

• The World Health Organization (WHO) updates its patient care guidelines to include interleukin-6 receptor blockers, a class of medicines that are lifesaving in patients who are severely or critically ill with COVID-19, especially when administered alongside corticosteroids. These were the findings from a prospective and a living network meta-analysis initiated by WHO, the largest such analysis on the drugs to date. Data from over 10,000 patients enrolled in 27 clinical trials were considered. These are the first drugs found to be effective against COVID-19 since corticosteroids were recommended by WHO in September 2020.

• Innate Pharma announces its Phase II FORCE trial evaluating avdoralimab in COVID-19 patients with severe pneumonia did not meet its primary endpoints in all three cohorts. Based on these results, Innate says it will stop exploring avdoralimab in COVID-19.

6 July:

• Israel will send 700,000 doses of the Pfizer/BioNTech COVID-19 vaccine that are shortly due to expire to South Korea by the end of July in a hastily arranged swap deal. In return, South Korea will return the same quantity of vaccines to Israel from a future order in September-October 2021.

• European Union countries have ordered 36.7 million additional doses of Johnson & Johnson’s COVID-19 single-shot vaccine, a European Commission spokesman tells Reuters. The EU initially ordered 200 million doses with the option for another 200 million.

5 July:

• A preliminary study by the Israeli Health Ministry finds that the Pfizer/BioNTech vaccine is less effective at preventing the spread of the Delta variant than previous strains. The data suggest the shot is 64% effective against Delta, compared to 94% against previous strains. However, the study found the shot is 93% effective against serious illness and hospitalisation.

2 July:

• Johnson & Johnson says new data shows its single-shot COVID-19 vaccine generated strong, persistent activity against the rapidly spreading Delta variant and other highly prevalent SARS-CoV-2 viral variants. In addition, the data showed that the durability of the immune response lasted through at least eight months, the length of time evaluated to date.

• German Health Minister Jens Spahn tells reporters that combining a first shot of the AstraZeneca COVID-19 vaccine with a second shot of an mRNA vaccine such as those from BioNTech/Pfizer or Moderna provides more protection against the highly infectious Delta variant than two shots of AstraZeneca's shot.

1 July:

• Moderna confirms that drug product manufacture of its mRNA COVID-19 vaccine has started at CDMO Recipharm’s site in France. The shot was approved by the European Medicines Agency’s Committee for Human Medicines on June 11.

• Roche and Atea Pharmaceuticals announced that their jointly developed AT-527, an oral direct-acting antiviral (DAA) agent has shown promise against COVID-9 in a Phase II trial. An interim analysis of the study included data from 70 hospitalized, high-risk patients with COVID-19 of which data from 62 patients were evaluable for virology analysis. Interim virology results indicated that AT-527 rapidly reduced viral load levels.

• CureVac says it will press ahead with seeking approval for its COVID-19 vaccine, CVnCoV, despite the shot demonstrating just 48% overall efficacy in a Phase 2b/3 study. The company says “significant protection” was demonstrated among participants in the 18-60 age group, with an efficacy of 53% against disease of any severity and across all 15 identified strains while protection against moderate to severe disease was 77%. In the same age group, CVnCoV provided 100% protection against hospitalization or death.

30 June:

• The Swiss government will donate 4 million doses of AstraZeneca’s COVID-19 vaccine to the COVX Facility. Switzerland originally reserved 5.4 million doses of the shot, yet to be approved by the country’s regulator, Swissmedic.

• China’s Clover Biopharmaceuticals signs an advance purchase agreement with Gavi, the Vaccine Alliance, to provide up to 414 million doses of its COVID-19 vaccine candidate – currently in late-stage trials -- for procurement through the COVAX Facility. Clover will make an initial 64 million doses available for procurement through COVAX in 2021. Gavi also retains options to procure up to an additional 350 million doses to be delivered in 2022.

29 June:

• Moderna announces that the Indian government has issued an emergency use authorisation for its COVID-19 vaccine to be imported into the country.

• Generics companies Cipla, Dr. Reddy’s, Emcure, Sun Pharma and Torrent announce that they will collaborate for the clinical trial of investigational oral anti-viral drug Molnupiravir for the treatment of mild COVID-19 in an outpatient setting in India. Between March and April this year, the companies had individually entered into a non-exclusive voluntary licensing agreement with Merck Sharpe Dohme (MSD) to manufacture and supply Molnupiravir to India and over 100 low and middle-income countries.

28 June:

• Dr. Reddy’s announces the commercial launch of 2-deoxy-D-glucose (2-DG), an oral drug administered to hospitalised moderate to severe COVID-19 patients as an adjunct therapy to the existing standard of care. Emergency use approval for anti-COVID-19 therapeutic application of the drug was granted on May 1.

• An Oxford University study finds that a third dose of AstraZeneca’s COVID-19 vaccine increases antibody and T-cell immune responses and a long interval between first and second doses does not compromise the immune response after a late second dose. “It is not known if booster jabs will be needed due to waning immunity or to augment immunity against variants of concern,” says Associate Professor Teresa Lambe, lead senior author for the study.

25 June:

• The European Medicines Agency’s committee for human medicines approves CDMO Catalent’s facility in Anagni, Italy for finished product manufacturing of Johnson & Johnson’s COVID-19 vaccine.

The Assistant Secretary for Preparedness and Response (ASPR) and the Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services are committed to ensuring timely and transparent communication regarding the COVID-19 monoclonal antibody treatments currently authorized for emergency use in certain patients with COVID-19.

• The US pauses all distribution of Eli Lilly’s antibody combination of bamlanivimab and etesevimab until further notice. In vitro assays suggest that the antibodies, when paired together, are not active against either the Gamma variant (first identified in Brazil) and the Beta variant (first identified in South Africa).

24 June:

• The US Food and Drug Administration issue an emergency use authorization for Roche’s drug Actemra (tocilizumab) for the treatment of hospitalized adults and pediatric patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. Actemra is not authorized for use in outpatients with COVID-19.

• European Union countries will receive about 900 million doses of COVID-19 vaccines in H2 2021, compared to nearly 1 billion shots estimated a month ago, an internal European Commission document seen by Reuters shows. The document also shows the EU is forecast to receive fewer doses in the first half of the year, compared to its own predictions in late May.

23 June:

• The MOMI-VAX study, funded by the US National Institutes of Health, starts to evaluate the immune responses generated by COVID-19 vaccines administered to pregnant or postpartum people. Researchers will measure the development and durability of antibodies against SARS-CoV-2 in people vaccinated during pregnancy or the first two postpartum months. Researchers also will assess vaccine safety and evaluate the transfer of vaccine-induced antibodies to infants across the placenta and through breast milk.

• The US government says it will send 3 million doses of Johnson & Johnson’s COVID-19 vaccine to Brazil. The shipment is part of President Joe Biden’s pledge to send 80 million doses overseas by the end of June.

22 June:

• Thermo Fisher Scientific launches a new CE-IVD-marked COVID-19 test, the TaqPath COVID-19 Fast PCR Combo Kit 2.0. The kit uses an advanced assay design which the company says helps to ensure the test provides accurate results even as the virus that causes COVID-19 continues to mutate.

• The European Commission approves an amendment to its second contract with Moderna for an additional 150 million doses in 2022. The revised contract provides for the possibility to purchase vaccines adapted to virus variants as well as vaccines for paediatric use and booster vaccines.

21 June:

• On the eve of BioNTech’s annual shareholder meeting, Médecins Sans Frontières calls on the Germany-based company that along with Pfizer developed an mRNA COVID-19 vaccine, to “immediately and openly share its vaccine technology and knowledge with able manufacturers in developing countries, to help ramp up production of lifesaving vaccines for countries still waiting for sufficient supply.” MSF says BioNTech’s recently announced plan to establish vaccine manufacturing on the African continent over the next 4-5 years “should go hand in hand with the company immediately sharing its technology and recipe with manufacturers ready to start producing now.”

• Tonix Pharmaceuticals announces plans to develop TNX-102 SL (cyclobenzaprine HCl sublingual tablets) as a potential treatment for Long COVID. Tonix plans to meet with the US Food and Drug Administration in the third quarter of 2021 to discuss the design of a potential Phase 2 pivotal study and the overall clinical development plan to qualify TNX-102 SL as an indicated treatment for Long COVID.

• GlaxoSmithKline and Vir Biotechnology announce that in a Phase 3 trial, that their drug, sotrovimab, an investigational SARS-CoV-2 monoclonal antibody, significantly reduced the risk of hospitalization or death by 74% among high-risk adult outpatients with mild-to-moderate COVID-19. The US National Institutes of Health has updated its COVID-19 treatment guidelines to recommend sotrovimab for non-hospitalized patients with mild-to-moderate COVID-19 who are at high risk of clinical progression and noted that sotrovimab appears to retain activity against current variants of concern and interest.

18 June:

• AstraZeneca must supply the European Union with 80.2 million doses of its COVID-19 vaccine by 27 September, a judge has ruled in the Court of First Instance in Brussels. The European Commission had requested 120 million vaccine doses cumulatively by the end of June 2021, and a total of 300 million doses by the end of September 2021. AstraZeneca welcomes the ruling, saying it will substantially exceed 80.2 million doses by the end of June. All other measures sought by the European Commission have been dismissed, and in particular the Court found that the European Commission has no exclusivity or right of priority over all other contracting parties.

17 June:

• The European Medicines Agency confirms it will not impose a 50% threshold for COVID-19 vaccine efficacy in the light of CureVac’s vaccine demonstrating only 47% efficacy in a Phase 2b/3 trial. “We will need to collect all the final data from this clinical trial, and have a good analysis of the outcome throughout different regions, age groups and according to different variants,” Marco Cavaleri, head of Biological Health Threats and Vaccines Strategy at the EMA, tells reporters.

• CureVac announces disappointing results from a pivotal Phase 2b/3 study in approximatively 40,000 subjects for its COVID-19 vaccine candidate, CVnCoV. The shot demonstrated an efficacy of 47% against COVID-19 of any severity and did not meet prespecified statistical success criteria, the company says, adding that initial analyses suggest age and strain dependent efficacy, amid the unprecedented context of at least 13 variants circulating. “While we were hoping for a stronger interim outcome, we recognize that demonstrating high efficacy in this unprecedented broad diversity of variants is challenging,” says Dr. Franz-Werner Haas, Chief Executive Officer of CureVac.

16 June:

• Moderna says the US government has purchased an additional 200 million doses of its COVID-19 vaccine, including the option to purchase other COVID-19 vaccine candidates from Moderna’s pipeline. The purchase brings the US government’s confirmed order commitment to 500 million doses including 110 million doses expected to be delivered in the fourth quarter of 2021 and 90 million expected to be delivered in the first quarter of 2022.

• Regeneron Pharmaceuticals says that in a UK trial, its investigational REGEN-COV antibody cocktail reduced the risk of death by 20% in patients who had not mounted a natural antibody response on their own against SARS-CoV-2, compared to usual care on its own.

• Moderna and Magenta Investments announce a new agreement to distribute Moderna’s COVID-19 vaccine as well as its updated variant booster candidates, once authorized, in the United Arab Emirates in 2021 and 2022.

• Daiichi Sankyo says it has made its shipment of AstraZeneca’s COVID-19 vaccine which it manufactured under an agreement made in February. The shipment will go to Southeast Asian countries and other regions through the Japanese government.

15 June:

• AstraZeneca says that in a study, its investigational antibody combination, AZD7442, did not meet the primary endpoint of preventing COVID-19 symptoms in infected patients. However, AZD7442 did reduce the risk of developing symptomatic COVID-19 by 73% compared with placebo, in participants who were PCR negative at time of dosing.

• Daiichi Sankyo announces it has decided to discontinue development of its nafamostat inhalation formulation (DS-2319) for treatment of COVID-19. The company said it expected nafamostat might exert a therapeutic effect by blocking membrane fusion between the envelope of the virus that causes COVID-19 and the host plasma cell membrane and initiated a phase 1 trial in March 2021. “In view of situations of ongoing non-clinical studies and the phase 1 trial, however, Daiichi Sankyo has decided to discontinue the development of DS-2319,” the company says.

14 June:

• Aspen says it is “extremely disappointed” that specific batches of Johnson & Johnson’s COVID-19 vaccine manufactured at its Gqeberha production site and designated for the South African market have to be destroyed due to the GMP risk of isolated material in the drug substance supplied to Aspen by J&J from their contract manufacturing partner in the US, Emergent BioSolutions. Aspen says the batches manufactured had been retained in storage awaiting the outcome of the US Food and Drug Administration’s assessment of Emergent.

• Novavax announces that results from a Phase 3 clinical trial demonstrated that its COVID-19 vaccine, NVX-CoV2373, offered 100% protection against moderate and severe disease, and 90.4% efficacy overall. The study enrolled 29,960 participants across 119 sites in the US and Mexico. Novavax says it intends to file for regulatory authorizations in the third quarter and remains on track to reach manufacturing capacity of 100 million doses per month by the end of Q3 and 150 million doses per month by the end of 2021.

13 June:

• India’s Sun Pharma says it has no immediate plans to enter into vaccine production as getting into the vertical would require a different, dedicated manufacturing facility, the company’s managing director, Dilip Shanghvi tells analysts on a call.

11 June:

• The European Medicines Agency’s committee for human medicines says it has approved a new manufacturing site for the production of Moderna’s COVID-19 vaccine finished product. The site, operated by CDMO Recipharm, is in Monts, France.

• Moderna and Tabuk Pharmaceutical Manufacturing Company announce an agreement to commercialize Moderna’s COVID-19 vaccine and future variant-specific booster candidates in Saudi Arabia. Under the terms of the deal, Tabuk will hold the marketing authorization for the vaccine in Saudi Arabia.

• The European Medicines Agency says that authorities in the EU are aware that a batch of the active substance for Johnson & Johnson’s COVID-19 vaccine had been contaminated with materials for another vaccine manufactured at the same site. The contamination occurred at Emergent BioSolutions’ manufacturing site for the active substance in Maryland, US. The batch concerned was not intended for the EU market. “Based on available information, batches of the vaccine released in the EU are not affected by the cross contamination,” the agency says.

• The European Medicines Agency’s safety committee  concludes that people who have previously had capillary leak syndrome must not be vaccinated with AstraZeneca’s COVID-19 vaccine and that CLS should be added to the product information as a new side effect of the vaccine. The committee carried out a review of 6 cases of CLS in people who had received the shot. CLS is a very rare, serious condition that causes fluid leakage from small blood vessels, resulting in swelling mainly in the arms and legs, low blood pressure, thickening of the blood and low blood levels of albumin.

10 June:

• Moderna says it has requested an emergency use authorization for its COVID-19 vaccine in adolescents with the US Food and Drug Administration.

• Johnson & Johnson says the US Food & Drug Administration has authorized an extension of the shelf life for its single-shot COVID-19 vaccine from 3 months to 4.5 months. The decision is based on data from ongoing stability assessment studies, which demonstrated that the vaccine is stable at 4.5 months when refrigerated at temperatures of 36 – 46 degrees Fahrenheit (2 – 8 degrees Celsius).

9 June:

• Merck says it has signed a deal with the US government for around 1.7 million doses of molnupiravir (MK-4482), currently being evaluated in Phase 3 for the treatment of non-hospitalized patients with COVID-19 and at least one risk factor associated with poor disease outcomes. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics.

8 June:

• Pfizer CEO Albert Bourla tweets that the company has begun dosing children aged 5-11 in a global Phase II/III study of the Pfizer-BioNTech vaccine against COVID-19. “This is an essential study to help further evaluate the vaccine and, if safety and immunogenicity in this age group is confirmed, protect our communities and children aged 5 to 11,” he said.

• CDMO AGC Biologics announces a partnership with BioNTech to further supply Plasmid DNA starting material for the Pfizer-BioNTech COVID-19 vaccine, at AGC’s Heidelberg, Germany facility.

• Virtual clinical development specialist, Phesi, releases findings from analysis of over 166,239 COVID-19 patient profiles from 56 countries that obesity poses the highest risk factor for poorer outcomes from COVID-19 for those under 40.

7 June:

• Translate Bio announces it has achieved a manufacturing milestone under its collaboration with Sanofi Pasteur related to its influenza mRNA vaccine program. Translate Bio will receive a $50 million payment from Sanofi Pasteur for the successful manufacture, release, and delivery of clinical drug product to supply Sanofi Pasteur’s Phase 1 influenza clinical trial which is anticipated to begin in the coming weeks. The collaboration, first signed in June 2018, was expanded in March 2020 to include development of a novel mRNA vaccine for COVID-19.

• Moderna announces it has submitted for a conditional marketing approval for its COVID-19 vaccine in adolescents aged 12 and over with the European Medicines Agency.

4 June:

• Regeneron announces the US Food and Drug Administration has updated the emergency use authorization for its antibody cocktail treatment against COVID-19, REGEN-COV, jointly developed with Roche. The dose has been halved to 1,200 mg (600 mg casirivimab and 600 mg imdevimab). As part of the updated EUA, REGEN-COV should be administered by intravenous infusion but subcutaneous injections are an alternative when IV infusion is not feasible and would lead to a delay in treatment.

3 June:

• The European Union has bought 55,000 doses of Roche and Regeneron’s monoclonal antibody treatment against COVID-19, according to a Reuters report. The deal was reportedly made in April but contract details were not made public. The drug is still not authorised for use in Europe.

• The Biden Administration announces that the US will share at least three-quarters of its donated doses of COVID-19 vaccines through the COVAX facility, prioritising Latin America and the Caribbean, South and Southeast Asia, and Africa. This translates to 19 million shots out of the initial tranche of 25 million. The remaining 6 million will be targeted toward regional priorities and partner recipients including Mexico, Canada and South Korea.

2 June:

• CDMO Lonza says it will install a new manufacturing line for drug substance production at its Geleen site in the Netherlands to support the manufacture of an extra 300 million doses per year of Moderna’s mRNA vaccine against COVID-19, as part of an expanded collaboration with the biotech.

• Moderna has also signed up Thermo Fisher Scientific for fill/finish sterile manufacturing services and supply packaging for its COVID-19 vaccine at the CDMO’s Greenville, North Carolina site. Production will begin in the third quarter of 2021.

• Moderna also signs a long-term agreement with UNICEF for the supply of COVID-19 vaccines on behalf of the COVAX Facility as part of an agreement announced in May. UNICEF and its procurement partners, including the Pan American Health Organization, will have access to up to 34 million doses of Moderna’s shot to be delivered in the fourth quarter 2021 and up to 466 million doses in 2022.

• The US National Institutes of Health says it has started a Phase I/II clinical trial in which adult volunteers who have been fully vaccinated against COVID-19 will receive booster doses of different COVID-19 vaccines to determine the safety and immunogenicity of mixed boosted regimens. The National Institute of Allergy and Infectious Diseases, part of NIH, is leading and funding the study through the Infectious Diseases Clinical Research Consortium, a clinical trials network that encompasses the Institute’s Vaccine and Treatment Evaluation Units.

1 June:

• Abbott Laboratories says it expects reduced 2021 sales in COVID-19 diagnostics from $6.5 billion to $4-4.5 billion due to lower demand amid lowering case numbers in the US and other developed countries, accelerated rollout of COVID-19 vaccines and, most, recently, US health authority guidance on testing for fully vaccinated adults. “While it’s positive that these external events and trends signal an accelerated return to normalcy for many countries, they have suddenly and fundamentally impacted market demand for COVID-19 testing, particularly for surveillance and screening with rapid testing,” the company says.

• The World Health Organisation approves Beijing-based Sinovac’s COVID-19 vaccine for emergency use. The Emergency Use Listing is a prerequisite for COVAX Facility vaccine supply and international procurement and allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines. “The world desperately needs multiple COVID-19 vaccines to address the huge access inequity across the globe,” says Dr Mariângela Simão, WHO Assistant-Director General for Access to Health Products. “We urge manufacturers to participate in the COVAX Facility, share their knowhow and data and contribute to bringing the pandemic under control.”

• India’s Biological E. says it has signed a deal with Providence Therapeutics to manufacture the Canadian firm’s mRNA vaccines in India, with a minimum production capacity of 600 million doses in 2022 and a target capacity of 1 billion doses. Biological E will be responsible for all clinical development and regulatory activities for the mRNA vaccine in India.

• Moderna says it has initiated the rolling submission process with the US Food and Drug Administration for a Biologics License Application for its mRNA COVID-19 vaccine in individuals 18 years of age and older. The vaccine is currently being distributed under an emergency use authorisation.

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