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Friday, January 15th, 2021

Pfizer/BioNTech COVID-19 vaccine first to gain WHO emergency use validation

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The World Health Organization (WHO) issued emergency use validation for the Pfizer/BioNTech Comirnaty mRNA vaccine last week, ending 2020 by issuing the first such validation for a COVID-19 vaccine.

The global organization’s declaration will allow countries to expedite their regulatory approval processes for the importation and administration of the vaccine and allows both UNICEF and the Pan-American Health Organization to tap their resources for procurement and distribution of the vaccine for countries in need.

The validation was provided following assessments by independent experts and WHO teams of phase two and three clinical trial data, a risk management plan, and additional safety, efficacy, and quality data. Those teams found the vaccine met the must-have criteria for safety and efficacy established by the WHO and that its benefits outweigh any potential risks.

“This is a very positive step towards ensuring global access to COVID-19 vaccines,” said Dr. Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products. “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. 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.”

Comirnaty does require storage at between -76 degrees Fahrenheit to -130 degrees Fahrenheit, making it difficult to deploy in settings where appropriately ultra-cold equipment is either unavailable or reliably accessible. WHO is working to assess delivery plans and preparing for use where possible. The vaccine also remains under the WHO policy review. Pfizer/BioNTech will continue to submit data to WHO to further complete licensure and prequalify the vaccine down the road.