The World Health Organization on Thursday granted emergency validation to the Pfizer-BioNTech vaccine, paving the way for countries worldwide to quickly approve its import and distribution.
Britain launched its inoculation drive with the US-German vaccine on December 8, with the United States, Canada and EU countries following suit.
WHO said the Pfizer/BioNTech vaccine was the first to receive its “emergency validation” since the novel coronavirus first broke out in China a year ago.
“This is a very positive step towards ensuring global access to COVID-19 vaccines,” said Mariangela Simao, a top WHO official tasked with ensuring access to medicines.
“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 said in a statement.
WHO said its emergency use listing opens the way for regulators in different countries to approve the import and distribution of the vaccine.
It said it also enables UNICEF, which plays a key logistical role in distributing anti-COVID vaccines, and the Pan-American Health Organization to procure the vaccine for countries that need it.
WHO convened its own experts and those from around the world to review the data on the Pfizer/BioNTech vaccine’s “safety, efficacy and quality,” weighing the benefits against the risks.
“The review found that the vaccine met the must-have criteria for safety and efficacy set out by WHO, and that the benefits of using the vaccine to address COVID-19 offset potential risks,” it said.
On December 11, 2020, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.
The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.
Emergency Use Authorization Status:AuthorizedName:Pfizer-BioNTech COVID-19 VaccineManufacturer:Pfizer Inc.
Authorized Use
For the prevention of 2019 coronavirus disease (COVID-19) for individuals 16 years of age and older
Common Side Effects
The most commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever. Of note, more people experienced these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose. Learn more.
Additional Information
| Information | Language |
|---|---|
| Letter of Authorization | English |
| Fact Sheet for Healthcare Providers Administering Vaccine | English |
| Fact Sheet for Recipients and Caregivers | English |
| FDA Decision Memorandum | English |
| Frequently Asked Questions on the Pfizer-BioNTech COVID-19 Vaccine | English |
| Press Release | English |
| 12/10/2020 Advisory Committee Meeting Information | English |
