The World Health Organization (WHO) today listed the Comirnaty COVID-19 mRNA vaccine for emergency use, making the Pfizer / BioNTech vaccine the first to receive emergency validation from the WHO since the start of the epidemic a year ago.
The WHO Emergency Use List (EUL) opens the door for countries to speed up their own regulatory approval processes to import and administer the vaccine. It also enables UNICEF and the Pan American Health Organization to procure the vaccine for distribution to countries in need.
“This is a very positive step in ensuring global access to COVID-19 vaccines. But I want to stress the need for an even greater global effort to achieve sufficient vaccine supply to meet the needs of priority populations everywhere, ”said Dr Mariângela Simão, WHO Assistant Director-General for ‘access to drugs and health products. “WHO and our partners are working day and night to evaluate other vaccines that have met standards for safety and efficacy. We are encouraging even more developers to come forward for review and evaluation. Securing the essential supplies needed to serve every country in the world and contain the pandemic is vitally important. “
Regulatory experts brought together by WHO from around the world and its own teams reviewed the data on the safety, efficacy and quality of the Pfizer / BioNTech vaccine as part of a risk / benefit analysis. The review found that the vaccine met the essential criteria for safety and efficacy defined by the WHO, and that the benefits of using the vaccine to fight COVID-19 outweighed the potential risks.
The vaccine is also under policy review. The WHO Strategic Advisory Group of Experts on Immunization (SAGE) will meet on January 5, 2021 to formulate vaccine-specific policies and recommendations for use of this product in populations, based on the recommendations SAGE population prioritization report for COVID-19 vaccines in general, published in September 2020.
The Comirnaty vaccine requires ultra-cold chain storage; it should be stored between -60 ° C and -90 ° C degrees. This requirement makes the vaccine more difficult to deploy in settings where ultra-cold chain equipment may not be available or reliably accessible. For this reason, WHO is working to help countries assess their delivery plans and prepare for their use where possible.
How the emergency use list works
The Emergency Use List (EUL) procedure assesses the suitability of new health products during public health emergencies. The aim is to make medicines, vaccines and diagnostics available as quickly as possible to deal with the emergency while respecting strict criteria of safety, efficacy and quality. The assessment weighs the threat posed by the emergency as well as the benefits that would result from the use of the product against the potential risks.
The EUL journey involves a rigorous evaluation of data from late phase II and phase III clinical trials as well as substantial additional data on safety, efficacy, quality and a risk management plan. These data are reviewed by independent experts and WHO teams who review the current body of evidence on the vaccine under consideration, plans for monitoring its use, and plans for further studies.
Experts from different national authorities are invited to participate in the review of the EUL. Once a vaccine has been listed for emergency use by WHO, WHO engages its regional regulatory networks and partners to inform national health authorities about the vaccine and its expected benefits based on the data. clinical studies to date.
In addition to global, regional and national regulatory procedures for emergency use, each country undertakes a political process to decide whether and in whom to use the vaccine, with a specified prioritization for earliest use. Countries are also undertaking a vaccine readiness assessment that informs the vaccine deployment and the introduction plan for vaccine implementation under the EUL.
As part of the EUL process, the company producing the vaccine must commit to continuing to generate data to enable full licensing and WHO prequalification of the vaccine. The WHO prequalification process will assess additional clinical data generated by the testing and deployment of vaccines on an ongoing basis to ensure that the vaccine meets the necessary standards of quality, safety and efficacy for further great availability.