FDA Officially Clears Pfizer's COVID-19 Vaccine, Initial Doses Ship in Days
The Food and Drug Administration officially authorized Pfizer and BioNTech's COVID-19 vaccine for emergency use on Friday, Dec. 11 — paving the way for millions of people at risk of contracting the illness to receive a viable vaccine to the coronavirus in the next few days, according to an evening press release from the FDA.
The first shipment of roughly 2.9 million doses of the COVID-19 vaccine will ship across the U.S. throughout the next week.
FDA grants emergency use authorization to Pfizer's COVID-19 vaccine
This marks a world-historic shift in the United States' struggle against the COVID-19 virus — which has killed more than 290,000 people in the country, as of writing. With this authorization, the U.S. joins five other countries — including Bahrain, Canada, Mexico, Britain, and Saudi Arabia — to approve distribution and use of the vaccine.
The European Union and other nations are expected to approve the Pfizer/BioNTech vaccine within weeks, the New York Times reports.
UPDATE Dec. 11, 10:25 PM EST: Pfizer COVID-19 vaccine still needs Phase 3 trial review
With the emergency use authorization (EUA), COVID-19 vaccines will first go to patients falling in the category of "highly vulnerable individuals," which include senior citizens living in long-term care facilities and healthcare workers. They should start receiving Pfizer's vaccine within days.
However, this EUA doesn't include full certification from the U.S. therapeutics regulator — and still needs a comprehensive review of Pfizer's available information from its Phase 3 clinical trial, which involved a group of 44,000 volunteer participants.
Pfizer had determined its vaccine — which is an mRNA-based treatment — showed a 95% effectiveness rating in the final analysis of the trial to-date. Additionally, the firm said safety evaluations indicated no substantial risks to health observed in patients who received the vaccine.
UPDATE Dec. 11, 10:30 PM EST: FDA may grant Moderna's vaccine EUA soon, making two viable vaccines before end of year
The U.S. aims to distribute another 25 million doses before 2020 is out, in addition to the initial 2.9 million doses — which might result in fewer people receiving the full two-dose vaccination course required for maximum efficiency.
Of course, Moderna's vaccine candidate is still awaiting EUA from the FDA on its vaccine candidate — which is also an mRNA treatment. This may happen shortly, which would make two vaccines available with EUA inside the U.S. before the end of 2020.
However, in granting EUA for distribution of Pfizer's COVID-19 vaccine, the FDA has helped make history in terms of vaccine development time — as roughly eight months have passed since work began on the Pfizer vaccine candidate.