WHO Grants ‘Emergency Validation’ to Pfizer-BioNTech COVID Vaccine

This opens doors for countries to expedite their own approval processes to import and administer the vaccine.

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The World Health Organization (WHO) granted ‘emergency validation’ to the Pfizer-BioNTech coronavirus vaccine on Thursday, 31 December, opening doors for countries to “expedite their own regulatory approval processes to import and administer the vaccine.”

In a press release, the WHO stated that it had “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 a year ago.”

The Assistant-Director General for Access to Medicines and Health Products of the world body, Dr Mariangela Simao called it a “very positive step towards ensuring global access to COVID-19 vaccines.”

“But I want to emphasise the need for an even greater global effort to achieve enough vaccine supply to meet the needs of priority populations everywhere,”she added.

As part of the Emergency Use Listing assessment, WHO had convened regulatory experts from around the world to review the data on the Pfizer/BioNTech vaccine’s safety, efficacy and quality. They found that the vaccine “met the must-have criteria for safety and efficacy set out by WHO.”

The announcement also enables UNICEF and the Pan-American Health Organization to procure the vaccine for distribution to countries in need.

Earlier, the United Kingdom had approved the Pfizer-BioNTech vaccine for rollout. The vaccine was found to provide strong protection against COVID-19 within about 10 days of the first dose, according to a report published by the US Food and Drug Administration.

The WHO is also working on a vaccine policy and recommendations for this product’s use in populations. It’s also working to support countries in assessing their delivery plans since the vaccine must be stored in ultra-cold condition, between -60°C to -90°C degrees.

The Subject Expert Committee (SEC) in the Central Drugs Standard Control Organisation (CDSCO) In India is also set to consider the Emergency Use Authorisation (EUA) request of COVID vaccines by Pfizer, Serum Institute of India (SII) and Bharat Biotech Pvt Ltd.