The World Health Organization (WHO) says that it has approved the Pfizer-BioNTech coronavirus vaccine for emergency use, meaning that poorer countries will soon have access to the shot that is already available in Europe and North America.
For any COVID-19 vaccine, every country that has a drug regulatory agency would have to issue its own approval, but nations with inadequate systems typically depend on WHO to check the shots.
The global body 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 UN health agency said its review found the vaccine developed by American drugmaker Pfizer and its German partner BioNTech, 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.”
Meanwhile, Britain became the first country in the world to approve the more affordable and easier to store coronavirus vaccine developed by Oxford University and AstraZeneca amid concerns about a new strain of the virus spreading fast.
The approval from the medicines regulator shows that the vaccine is both safe and effective. The Oxford University and the UK-based multinational pharmaceutical company AstraZeneca started developing the vaccine in the first months of 2020 and tested it on the first volunteer in April, later large-scale clinical trials involving thousands of people were conducted.