FDA Approves Pfizer's COVID-19 Vaccine for Emergency Use

The Food and Drug Administration (FDA) approved Pfizer's vaccine to protect against the new coronavirus on Friday night, authorizing the immunization for emergency use in the United States.

The federal agency's decision marked a significant and long-awaited milestone amid the nation's ongoing COVID-19 response.

After a number of leading biotechnology and pharmaceutical companies moved to the forefront of the global race for a safe and effective COVID-19 vaccine, Pfizer's candidate became the first to receive an official nod from the FDA. Although the immunization is not yet approved for widespread distribution, the Emergency Use Authorization (EUA) will allow medical professionals to administer it under certain circumstances. In this case, high-risk groups, such as front line workers and nursing home residents, will receive the vaccination prior to broader approval and widespread distribution. The first shipment will be of around 2.9 million doses, according to the New York Times.

Pfizer, COVID-19 Vaccine, FDA, Emergency Use
A COVID-19 vaccine developed by Pfizer and German biotechnology company BioNTech received an emergency use authorization from the U.S. Food and Drug Administration on Friday. The logo of US multinational pharmaceutical company Pfizer, is pictured at a factory in Puurs, where Covid-19 vaccines are being produced for Britain, on December 3, 2020. KENZO TRIBOUILLARD/AFP via Getty Images

Pfizer and Moderna's respective COVID-19 vaccines each emerged as promising candidates last month, when analyses of late-stage clinical trials indicated the immunizations were highly, and comparably, effective.

Pfizer, which partnered with German biotechnology company BioNTech to develop its vaccine, announced the results of its trial analyses during the first week of November. At the time, it said that early data placed the immunization's effectiveness at 90 percent. About one week later, Moderna said results of its own analyses indicated the company's candidate was 94 percent effective at preventing COVID-19. The United Kingdom approved Pfizer's vaccine in early December and began distributing doses on December 7.

News of both vaccine candidates' reported efficacy drew immediate praise from health officials. Top U.S. immunologist Dr. Anthony Fauci, a leading member of Donald Trump's Coronavirus Task Force and director of the National Institute of Allergy and Infectious Diseases (NIAID), shared insights about how a viable immunization could impact the trajectory of the U.S. virus outbreak soon after, as the nation recorded new diagnoses and hospitalizations in record-breaking numbers.

"If you have a highly efficacious vaccine, and only a relatively small 40 or 50 percent of the people get vaccinated, you're not going to get the herd immunity you need," Fauci explained during an appearance on CBS News' Face the Nation November 22. The infectious disease expert also underscored the legitimacy of an FDA-approved candidate, noting that authorization means the general population can trust the immunization is safe and effective.

"When the American public hears that, you should be assured that that is the case," he said. "And if you get an overwhelming majority of the people vaccinated with a highly efficacious vaccine, we can, reasonably quickly, get to the herd immunity that would be a blanket of protection for the country."

As of Friday, more than 15.8 million people have tested positive for COVID-19 in the U.S. since last spring, according to Johns Hopkins University's tracker. Of them, 294,715 people have died.