WHO grants emergency use validation for Pfizer-BioNTech COVID-19 vaccine

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The World Health Organization (WHO) on Thursday said that it had issued an emergency use validation for the vaccine against the coronavirus developed by the Pfizer and BioNTech companies, the first one since the start of the pandemic.

Every country that has a drug regulatory agency will have to issue its own approval for any COVID-19 vaccine, but countries with weak systems usually rely on WHO to vet the shots.

The WHO said that the decision to issue its first emergency use validation for a COVID-19 vaccine “opens the door for countries to expedite their own regulatory approval processes to import and administer the vaccine.”

“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 a year ago,” the WHO said in a statement.

The WHO decision has enabled UNICEF and the Pan-American Health Organization to procure the vaccine for distribution to the countries in need.

“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,” WHO Assistant-Director General for Access to Medicines and Health Products Mariangela Simao said.

The BioNTech-Pfizer vaccine has to be stored at ultra-frozen temperatures, a big hurdle for developing countries where the required freezers and reliable electricity supply may not be available.

“This requirement makes the vaccine more challenging to deploy in settings where ultra-cold chain equipment may not be available or reliably accessible,” WHO said, adding that it was “working to support countries in assessing their delivery plans and preparing for use where possible”.

The WHO declared the COVID-19 outbreak a pandemic on March 11. To date, more than 83.1 million people have been infected with the coronavirus worldwide, with over 1.81 million fatalities, according to Johns Hopkins University.