FDA Gives Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization

As anticipated, the FDA has issued its first emergency use authorization for a COVID-19 vaccine.

The FDA tweeted at 9:40 p.m. last night that it had issued the authorization for Pfizer-BioNTech’s COVID-19 vaccine.

Eight minutes before the FDA tweet, President Donald Trump tweeted a 3-minute, 15-second video about the vaccine approval. “I have really good news. Today our nation has achieved a medical miracle,” he began. Trump said in the video statement that Fedex and UPS had already begun shipping the vaccine to every state and ZIP code in the country and that the first shot would be administered in 24 hours.

All signs pointed to the FDA approving the emergency use authorization for the Pfizer-BioNTech vaccine. Pfizer and BioNTech, a German company, had reported that their vaccine was 95% effective. An FDA advisory committee voted 17-4, with one abstention, on Thursday in favor of the vaccine. Drug regulators in the United Kingdom approved the Pfizer-BioNTech vaccine ten days ago.

Pfizer said in a statement posted last night that the two companies have the "potential" to supply globally 50 million vaccine doses this year and up to 1.3 billion by the end of next year.

The CDC has recommended that healthcare workers and residents of long-term care facilities be the first to be vaccinated when a COVID-19 vaccine becomes available. But decisions about distributing the vaccine and prioritizing different groups are being made at the state level.

The FDA is expected to approve a second COVID-19 vaccine, developed by Moderna, a Cambridge, Massachusetts, company, next week.

The statement the FDA issued last night says the Pfizer-BioNTech vaccine is 95% effective and in the placebo-controlled trial that led to the emergency use authorization, there were eight cases of COVID-19 among the 18,198 people who received the vaccine compared with 162 among the 18,325 who received the placebo. The FDA says one of the cases in the vaccine group was severe compared with three in the placebo group.

The most commonly reported side effects, which typically lasted several days, are pain at the injection site, tiredness, headache, muscle pain, chills, joint pain and fever, according to the FDA statement, which also says those side effect are experienced more commonly after the second dose.