Vaccine industry must help fight monkeypox and secure supply chains

Monkeypox is unlikely to develop into another pandemic, according to the WHO. But the recent spread of the virus could still be a challenge for the vaccine industry. 

But, while the surge in non-endemic countries is unusual[i], monkey pox is unlikely to go global because its route of transmission appears to differ from SARS-CoV-2, says the World Health Organisation (WHO). 

That said, the WHO is concerned about monkeypox[ii]. In June[iii], the Geneva-headquartered organisation called for 'intense response efforts' to control the spread of the virus. 

These efforts should include 'ensuring vaccines, treatments and other tools are available to at-risk populations and shared fairly' according to WHO chief Tedros Adhanom Ghebreysus, who noted that until recently monkeypox was not a focus for industry. 

'Monkeypox has been circulating in a number of African countries for decades and has been neglected in terms of research, attention and funding. This must change,' Ghebreysus said. 

Vaccines 

Current vaccination efforts are focused on products designed to protect against smallpox, based on the similarity of the viruses. According to the US Centers for Disease Control and Prevention (CDC) [iv], the 'smallpox vaccine is at least 85% effective in preventing monkeypox.'

In Europe[v], authorities have acquired 110,000 doses of Imvanex (also known as MVA-BN) - a smallpox vaccine made by Bavarian Nordic A/S – to allow for rapid containment of any monkeypox outbreaks. 

In June[vi], Bavarian Nordic said it would complete the order in the next few months. 

Imvanex contains a live modified form of the vaccinia virus called ‘vaccinia Ankara’, which is related to both the smallpox and monkeypox viruses. 

In the US, Imvanex – which is sold as Jynneos – is authorised for the prevention of both smallpox and monkeypox. It is also approved in Canada, where it is sold as Imvamune. 

In July, according to Bavarian Nordic[vii], the US Biomedical Advanced Research and Development Authority (BARDA) ordered 2.5 million Jynneos doses, having already bought three million doses in June. In total, the orders mean BARDA will have a stockpile of 7 million doses. 

Bavarian Nordic said the additional order will be filled by an unnamed US CDMO using bulk vaccine already manufactured under previous contracts.  

The Danish drug firm revised its financial guidance for 2022, citing the surge in Imvanex orders. It now expects revenue to be between DKK 2,700 and 2,900 million, though it previously predicted sales in the DKK 2,300 and 2,500 million range. 

Other vaccines  

In the US, a second vaccine called Acam2000 [viii] is also recommended by the CDC [ix] for people who may be exposed to orthopoxviruses, including monkeypox. 

Acam2000 contains a live virus called vaccinia, which is a "pox"-type virus related to smallpox but causes milder disease. The vaccine was developed by Sanofi Pasteur, however it was acquired by Emergent Biosolutions in 2017[x]. 

A third smallpox vaccine called LC16 – made by Kumamoto, Japan-based KM Biologics – is also a potential option for preventing monkeypox infection according [xi]to the WHO.  

The organisation wrote: 'For persons for whom replicating vaccines may be considered a precaution or are contraindicated, non-replicating (such as MVA-BN) or minimally replicating, such as LC16 vaccine should be used. This concerns persons with immune deficiencies, immunosuppression therapies or atopic dermatitis, as well as children and pregnant or breastfeeding women.'

The vaccine – which is an attenuated, replicating smallpox vaccine derived from the Lister strain of vaccinia - is the only smallpox vaccine licensed for use in Japan to prevent infection in children. 

Supplies 

The sudden surge in demand for vaccines that protect against monkeypox is stretching capacity to the limit. According to a WHO advisory in June, vaccine supply is 'very constrained.'

Concerns about supplies have already prompted some governments to restrict access. In the UK, for example, authorities [xii]have decided to give people one does of the MVA vaccine –rather than two recommended by Bavarian Nordic – in order to conserve stocks. 

To address these supply issues, the WHO called on governments and manufacturers to work together to ensure supply is made available. 

It said: 'Manufacturers are also encouraged to consider smallpox / monkeypox vaccine presentation and packaging to optimise operational features and reduce cold-chain requirements…Modern training materials should be developed and made available on accessible platforms for the use of bifurcated needles where required.'

Distribution of global monkeypox cases. Source: US Centers for Disease Control and Prevention

Vaccine candidates 

Several other monkeypox-specific vaccines have entered development. For example[xiii], Moderna – the firm behind the COVID-19 jab Spikevax – said it is testing potential vaccines against monkeypox in pre-clinical trials. 

Tonix Pharmaceuticals is also working on a jab. Last month, the firm shared preclinical data from a study of TNX-801, its monkeypox vaccine candidate. 

And beyond vaccines, several therapeutics are already being tested. According to a study published in the Lancet in May [xiv] two oral drugs, brincidofovir and tecovirimat, have been approved for treatment of smallpox and have demonstrated efficacy against monkeypox in animals. 

References
 
[i] https://www.who.int/news/item/25-06-2022-meeting-of-the-international-health-regulations-(2005)-emergency-committee--regarding-the-multi-country-monkeypox-outbreak 

[ii] https://www.who.int/news-room/speeches/item/who-director-general-s-statement-on-the-report-of-the-meeting-of-the-international-health-regulations-(2005)-emergency-committee--regarding-the-multi-country-monkeypox-outbreak 

[iii] https://news.un.org/en/story/2022/06/1121362 

[iv] https://www.cdc.gov/poxvirus/monkeypox/clinicians/smallpox-vaccine.html 

[v] https://www.ema.europa.eu/en/documents/public-statement/possible-use-vaccine-jynneos-against-infection-monkeypox-virus_en.pdf 

[vi] https://www.bavarian-nordic.com/investor/news/news.aspx?news=6585 

[vii] https://www.bavarian-nordic.com/investor/news/news.aspx?news=6591 

[viii] https://www.fda.gov/vaccines-blood-biologics/vaccines/acam2000-smallpox-vaccine-questions-and-answers 

[ix] https://www.cdc.gov/poxvirus/monkeypox/clinicians/smallpox-vaccine.html 

[x] https://investors.emergentbiosolutions.com/news-releases/news-release-details/emergent-biosolutions-acquire-acam2000r-business-sanofi 

[xi] https://apps.who.int/iris/rest/bitstreams/1433527/retrieve 

[xii] https://www.gov.uk/government/publications/monkeypox-vaccination-resources/protecting-you-from-monkeypox-information-on-the-smallpox-vaccination 

[xiii] https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-testing-potential-monkeypox-vaccines-2022-05-24/ 

[xiv] https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(22)00228-6/fulltext