Pfizer Receives WHO prequalification for multi-dose vial presentation of Prevenar 13
Designation will enable increased access to vaccine in world’s poorest countries.
Pfizer has announced that the World Health Organization (WHO) has prequalified its four-dose, multi-dose vial (MDV) presentation of Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13 – valent, adsorbed]). WHO prequalification allows for the global use of Prevenar 13 MDV by United Nations agencies and countries worldwide that require WHO prequalification.
“It is unconscionable that children in developing countries are still falling ill, or dying, by the hundreds of thousands every year from preventable diseases like invasive pneumococcal disease and meningitis,” said Orin Levine, director of the vaccine delivery team at the Bill & Melinda Gates Foundation. “We need a range of tools to save children's lives and welcome advances like this one that help improve our ability to prevent life-threatening invasive pneumococcal disease.”
“We are pleased that the WHO has prequalified the MDV presentation of Prevenar 13, another crucial step in providing broader global access to this important vaccine for those who need it,” said Susan Silbermann, President and General Manager, Pfizer Vaccines. “Pfizer is committed to continued innovation aimed at meeting the challenges of the developing world and helping to prevent invasive pneumococcal disease by providing a path for children in resource-limited countries to access a reliable supply of Prevenar 13.”
The MDV presentation of Prevenar 13 offers significant benefits to developing countries, including a 75% reduction in
The Prevenar 13 MDV presentation includes the preservative 2-Phenoxyethanol, which enables use of the vaccine over a 28-day period following its first use, provided it is stored at 2-8 degrees Celsius. This presentation has been approved in the European Union following the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in April 2016.
“It is encouraging to see vaccine manufacturers committed to addressing the unique conditions and challenges experienced by those of us working in communities whose health systems are still developing,” said Dawda Sowe, Program Manager, Expanded Program on Immunization, The Gambia. “The MDV presentation is expected to aid in increasing availability of Prevenar 13, thereby allowing us to help protect more infants and children against invasive pneumococcal disease.”
The prequalified MDV presentation is expected to be introduced under the Advance Market Commitment (AMC) program in early 2017, for shipment to countries supported by Gavi, the Vaccine Alliance (Gavi). In January 2015, during Gavi’s pledging conference, Pfizer began to prepare for the potential introduction of Prevenar 13 in the MDV presentation by announcing a 20 cent reduction in cost, from $3.30 per-dose to $3.10 per-dose, in its MDV per-dose price for Gavi-eligible countries. Once the MDV presentation is introduced under the AMC, this pricing is expected to be available to all Gavi-eligible countries. In addition, expanded availability will enable Gavi-graduated countries to access the same pricing until 2025.
Related News
-
News Patients vs Pharma – who will the Inflation Reduction Act affect the most?
The Inflation Reduction Act brought in by the Biden administration in 2022 aims to give better and more equitable access to healthcare in the USA. However, pharma companies are now concerned about the other potential costs of such legislation. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News CPHI Barcelona Annual Report illuminates industry trends for 2024
The CPHI Annual Survey comes into it’s 7th year to report on the predicted trends for 2024. Over 250 pharma executives were asked 35 questions, with their answers informing the industry landscape for the next year, spanning all major pharma marke... -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News EU Medical Devices Regulation causes unintended disappearances of medical devices for children, doctors state
Doctor groups and associations have appealed to the EU to correct the EU Medical Devices Regulation law that may cause unintended shortages of essential drug and medical devices for children and rare disease patients. -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Detecting Alzheimer's disease with a simple lateral flow test
A novel rapid diagnostic test for early-stage Alzheimer's disease has been developed using a biomarker binder from Aptamer Group along with technology from Neuro-Bio, the neurodegenerative disease experts. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance