The World Health Organization (WHO) recommended Pfizer/BioNTech vaccine – Comirnaty COVID-19 mRNA vaccine for emergency use. With this Pfizer/BioNTech vaccine became the first to receive emergency validation from WHO since the COVID-19 outbreak started a year ago.
The WHO’s Emergency Use Listing (EUL) created avenues for nations to facilitate their regulatory endorsement processes to import and administer the vaccine. It likewise empowers UNICEF and the Pan-American Health Organization to acquire the vaccine for dissemination to nations where they are urgently needed.
“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 achieve enough vaccine supply to meet the needs of priority populations everywhere,” said Dr. Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products. “WHO and our partners are working night and day to evaluate other vaccines that have reached safety and efficacy standards. We encourage even more developers to come forward for review and assessment. It’s vitally important that we secure the critical supply needed to serve all countries around the world and stem the pandemic.”
Both regulatory experts gathered by WHO from around the globe and WHO’s own groups appraise critically the data on the Pfizer/BioNTech vaccine’s safety, efficacy, and quality as part of a risk-versus-benefit analysis. The review found that the vaccine met the must-have criteria for safety and efficacy set out by WHO and that the benefits of using the vaccine to address COVID-19 offset potential risks.
The vaccine is also under critical policy evaluation. WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) will meet on 5 January 2021, to formulate vaccine-specific policies and recommendations for this product’s use in populations, drawing from the SAGE population prioritization recommendations for COVID-19 vaccines in general, issued in September 2020.
The Comirnaty vaccine needs ultra-cold chain storage at -60°C to -90°C degrees. The vaccine faces distribution issues especially in settings where ultra-cold chain equipment may not be available or reliably accessible. WHO is working to support countries in assessing their delivery plans and preparing for use where possible.
How the emergency use listing works
The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies. The objective is to make medicines, vaccines, and diagnostics available as rapidly as possible to address the emergency while adhering to stringent criteria of safety, efficacy, and quality. The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.
The EUL pathway involves a rigorous assessment of late phase II and phases 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 teams who consider the current body of evidence on the vaccine under consideration, the plans for monitoring 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 on the vaccine and its anticipated benefits based on data from clinical studies to date.
In addition to the global, regional, and country regulatory procedures for emergency use, each country undertakes a policy process to decide whether and in whom to use the vaccine, with prioritization specified for the earliest use. Countries also undertake a vaccine readiness assessment which informs the vaccine deployment and introduction plan for the implementation of the vaccine under the EUL.
As part of the EUL process, the company producing the vaccine must commit to continuing to generate data to enable full licensure and WHO prequalification of the vaccine. The WHO prequalification process will assess additional clinical data generated from vaccine trials and deployment on a rolling basis to ensure the vaccine meets the necessary standards of quality, safety, and efficacy for broader availability.
[/vc_column_text][/vc_column][/vc_row]
