The Food and Drug Administration approved emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine Friday, kicking off a massive vaccination campaign to begin early next week.
The first doses of the vaccine, deemed safe and effective enough for public use on Thursday by a panel of infectious disease experts, will be shipped out within 24 hours. The first shots could be administered as soon as Monday or Tuesday of next week, according to Health and Human Services Secretary Alex Azar.
Pfizer submitted the petition for the EUA about three weeks ago, just one day after announcing that the two-shot vaccine had a final efficacy of 95% in preventing the disease among adults without prior evidence of infection.
The vaccine uses technology that has never been approved before for public use in the United States. Messenger RNA, mRNA for short, tweaks the body’s genetic code to teach it to build the same spike protein as the one on top of the actual coronavirus. This triggers the immune response that protects against the virus and its resulting disease, known as COVID-19.
The U.S. government has secured 100 million doses of the Pfizer vaccine, enough to inoculate 50 million of the most vulnerable people, starting with healthcare workers and long-term care facility residents and staff in Phase 1a. Essential workers, such as police, grocery store employees, and teachers and school staff, will be eligible as part of Phase 1b. In Phase 1c, seniors over 65 and people with high-risk health conditions, such as diabetes, chronic kidney disease, cancer, and sickle cell disease, will be eligible for a vaccine.
The news comes at the tail end of the deadliest week of the pandemic recorded so far, with roughly 2,332 new daily deaths on average over the past seven days. That surpasses the previous record in mid-April, when the average daily deaths in a week reached 2,116. Hospitalizations related to COVID-19 have also hit an all-time high over the past week, with an average of about 103,000 new patients admitted every day.
While my pushing the money drenched but heavily bureaucratic @US_FDA saved five years in the approval of NUMEROUS great new vaccines, it is still a big, old, slow turtle. Get the dam vaccines out NOW, Dr. Hahn @SteveFDA. Stop playing games and start saving lives!!!
— Donald J. Trump (@realDonaldTrump) December 11, 2020
The FDA has received criticism from President Trump, who has accused it of delaying the vaccine review process in a political move to undermine him. Earlier Friday, White House Chief of Staff Mark Meadows told FDA Commissioner Stephen Hahn to submit his letter of resignation if the vaccine is not authorized by the end of the day, the Washington Post reported.
Trump called the approval a “medical miracle” on Friday night.
“I am thrilled to report the FDA has authorized the Pfizer vaccine. We have given Pfizer and other companies a great deal of money hoping this would be the outcome — and it was,” he said.
Trump added that the vaccine meets the “gold standard” of safety, touting his administration’s Operation Warp Speed.
“Through Operation Warp Speed, my administration provided a total of $14 billion to accelerate vaccine development and to manufacture all of the top candidates in advance,” he said. “I’m proud to say that we have made sure that this vaccine will be free for all Americans.”
— Donald J. Trump (@realDonaldTrump) December 12, 2020
