As the highly contagious Delta variant tore through healthcare systems, officials approved a third vaccine for those most at-risk

NEED TO KNOW

• The FDA approved the COVID booster in 2021 for high-risk groups, including older adults and frontline workers
• The approval came during a surge in Delta variant cases, which caused more severe and prolonged illness
• Officials emphasized the evolving nature of the pandemic and the importance of adapting vaccine strategies over time

As health officials struggled to manage a rapidly mutating COVID virus, five years ago the U.S. Food and Drug Administration approved an emergency authorization for a third shot of the vaccine— the COVID booster — for populations most at-risk. 

A third shot of the Pfizer-BioNTech COVID-19 vaccine was permitted for “a single booster dose, to be administered at least six months” after the initial two-shot vaccine, the FDA said in its Sept. 22, 2021 announcement. (The Moderna booster approval would come a month later.) The booster’s approval came amid a surge in cases from the highly contagious Delta variant, which made people sicker for longer — with “longer viral shedding,” per Clinical Infectious Diseases.

With the emergency authorization, the following people could get the third shot: Those ages 65 or older, those ages 18 through 64 at high risk of severe COVID-19, and anyone whose job or environment “puts them at high risk of serious complications of COVID-19 including severe COVID-19,” such as health care workers, those in child care, grocery workers and people in homeless shelters or prisons.

Acting FDA Commissioner Janet Woodcock said at the time that the approval for a third shot “demonstrates that science and the currently available data continue to guide the FDA’s decision-making for COVID-19 vaccines during this pandemic.”

“This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day,” Woodcock said. “As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed.”

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The approval came amid a spike in cases in unvaccinated people — and low-grade breakthrough infections as the virus mutated to evade the protections from vaccinations.

“We don’t have enough health care workers to take care of the unvaccinated,” Dr. Helen Keipp Talbot of Vanderbilt University told PBS News at the time. “They just keep coming.”

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