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 WHO emergency validation since the outbreak began a year ago.
The WHO Emergency Use List (EUL) opens the door for countries to streamline their own regulatory approval processes to import and administer the vaccine. It also allows UNICEF and the Pan American Health Organization to purchase the vaccine for distribution to countries in need.
“This is a very positive step towards ensuring global access to COVID-19 vaccines. But I want to emphasize the need for an even greater global effort to get enough vaccine to meet the needs of priority populations everywhere, ”said Dr. Mariângela Simão, WHO Deputy Director-General for Access to Medicines and Health Products “WHO and our partners are working day and night to evaluate other vaccines that have reached safety and efficacy standards. We encourage even more developers to come for review and evaluation. It is vitally important to ensure the critical supply necessary to serve all countries in the world and contain the pandemic. ”
Regulatory experts gathered by WHO from around the world and the WHO teams themselves reviewed data on the safety, efficacy and quality of the Pfizer / BioNTech vaccine as part of a risk versus benefit analysis. The review concluded that the vaccine met the mandatory safety and efficacy criteria established by WHO, and that the benefits of using the vaccine to treat COVID-19 outweigh the potential risks.
The vaccine is also under policy review. The WHO Strategic Advisory Group on Immunization Specialists (SAGE) will meet on January 5, 2021 to formulate specific vaccine policies and recommendations for the use of this product in populations, based on SAGE’s population prioritization recommendations for COVID- vaccines. 19 in general, issued in September 2020.
The Comirnaty vaccine requires storage using an ultra-cold chain; it needs to be stored between -60 ° C and -90 ° C degrees. This requirement makes the vaccine more challenging to deploy in locations where ultra-cold chain equipment may not be available or reliably accessible. For this reason, WHO is working to support countries in evaluating their birth plans and preparing for use when 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 objective is to make medicines, vaccines and diagnostics available as soon as possible to meet the emergency, respecting strict safety, efficacy and quality criteria. The assessment weighs the threat posed by the emergency, as well as the benefit that would accrue from using the product against any potential risks.
The EUL pathway involves a rigorous assessment of phase II and phase III clinical trial data, as well as substantial additional data on safety, efficacy, quality and a risk management plan. These data are reviewed by independent experts and WHO staff, who consider the current body of evidence on the vaccine under consideration, plans to monitor its use and plans for further studies.
Experts from individual national authorities are invited to participate in the EUL review. Once a vaccine has been listed for WHO emergency use, WHO involves its regional regulatory networks and partners to inform national health authorities about the vaccine and its expected benefits based on data from clinical studies to date.
In addition to global, regional and national regulatory procedures for emergency use, each country carries out a policy process to decide whether and on whom to use the vaccine, with specified prioritization for earlier use. Countries also conduct a vaccine readiness assessment that informs the vaccine implantation and introduction plan for the vaccine implementation under the EUL.
As part of the EUL process, the company that produces the vaccine must commit to continue to generate data to allow full licensing and prequalification of the vaccine by WHO. The WHO prequalification process will assess additional clinical data generated from vaccine testing and implantation on an ongoing basis to ensure that the vaccine meets the necessary standards of quality, safety and efficacy for wider availability.
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