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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 WHO since the outbreak began. one year.
The WHO Emergency Use List (EUL) opens the door for countries to accelerate 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 that need it.
“This is a very positive step to ensure global access to COVID-19 vaccines. But I want to emphasize the need for an even greater global effort to achieve a sufficient vaccine supply to meet the needs of priority populations everywhere, ”said Dr. Mariângela Simão, WHO Assistant Director-General for Access to Medicines and Products Sanitary. “WHO and our partners are working around the clock to evaluate other vaccines that have achieved safety and efficacy standards. We encourage more developers to come forward for review and evaluation. It is vitally important that we secure the critical supply necessary to serve all countries of the world and stop the pandemic. ”
Regulatory experts convened by WHO from around the world and WHO’s own teams reviewed data on the safety, efficacy and quality of the Pfizer / BioNTech vaccine as part of a risk versus benefit analysis. The review found that the vaccine met essential criteria for safety and efficacy established by the WHO, and that the benefits of using the vaccine to address COVID-19 outweigh 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 policies and specific vaccine recommendations for the use of this product in populations, based on the SAGE population prioritization recommendations. for COVID-19 vaccines in general, released in September 2020.
The Comirnaty vaccine requires storage through an ultra-cold chain; It should be stored between -60 ° C and -90 ° C degrees. This requirement makes the vaccine more difficult to implement in environments where ultra-cold chain equipment may not be available or reliably accessible. For that reason, WHO is working to help countries evaluate their delivery plans and prepare for their use when possible.
How the emergency use list works
The emergency use listing (EUL) procedure assesses the suitability of new medical devices during public health emergencies. The goal is to make medicines, vaccines and diagnostics available as quickly as possible to address the emergency, respecting strict criteria of safety, efficacy and quality. The assessment weighs the threat posed by the emergency, as well as the benefit to be gained from using the product against any potential risks.
The EUL pathway 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 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 engages its regional regulatory networks and partners to inform national health authorities about the vaccine and its anticipated 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 to use the vaccine and by whom, with specified prioritization for earliest use. Countries also conduct a vaccine readiness assessment that informs the deployment of the vaccine 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 allow full licensing and prequalification of the vaccine by WHO. The WHO prequalification process will evaluate additional clinical data generated from vaccine trials and deployment on an ongoing basis to ensure that the vaccine meets the necessary standards of quality, safety and efficacy for increased availability.
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