GENEVA — The World Health Organization says it has cleared the Pfizer-BioNTech coronavirus vaccine for emergency use, meaning poorer countries may soon get access to the shot already available in Europe and North America.
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 global body said late Thursday 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 U.N. health agency said its review found the Pfizer-BioNTech vaccine, which has already received clearance in the United States, Britain, the European Union and a dozen other countries, “met the must-have criteria for safety and efficacy set out by WHO.”
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.”