On December 11, 2020, the FDA Authorized the First COVID-19 Vaccine for Emergency Use in the United States
On Friday, Dec. 11, 2020, the U.S. Food and Drug Administration issued an emergency use authorization for the vaccine developed by Pfizer and BioNTech, making it the first COVID-19 vaccine cleared for use in the United States. The decision came on a winter evening when the country was recording some of its highest daily death tolls of the pandemic.
The Green Light
The authorization followed a meeting of the FDA's outside advisory committee the previous day, where independent experts voted 17 to 4, with one abstention, to back the vaccine for people 16 and older. The agency's review rested on a large clinical trial that found the two-dose regimen to be about 95 percent effective at preventing symptomatic COVID-19. Acting Commissioner Stephen Hahn signed off, and the agency described the action as the first emergency use authorization of a COVID-19 vaccine. The vaccine, made with messenger RNA technology that had never before been used in an approved vaccine, had moved from genetic sequence to regulatory clearance at a pace without precedent. Earlier vaccines had typically taken a decade or more to develop. The shots still needed to travel, however, and they had to be kept at ultra-cold temperatures, a logistical puzzle that required specialized freezers and carefully planned shipping long before the paperwork was complete.
Distribution began almost immediately. Shipments left Pfizer's Kalamazoo, Michigan, facility over the weekend, and the first vaccinations in the United States were administered on Monday, Dec. 14, to health care workers. Within days, the agency's attention turned to a second candidate from Moderna, which received its own authorization on Dec. 18. The speed of the effort drew scrutiny as well as celebration, with regulators and public health officials stressing that the review had not skipped its safety steps. For a country that had spent months waiting for any sign of an exit, the announcement was a quiet piece of paper with enormous consequences. Yet the authorization was only the beginning of a long campaign, since the hardest part, persuading hundreds of millions of people to roll up their sleeves, still lay ahead.
![[#~image_alt_1~#]](/_next/image?url=https%3A%2F%2Fd3klpa3rfwubzz.cloudfront.net%2Fmedia%2FAPI%20Uploads%2FTDH%2Ffd85522e406464a1b0bab01b092a8e60_3b2592ca33.jpg&w=1920&q=75)















