Pfizer and BioNTech on Tuesday asked the U.S. Food and Drug Administration to amend the emergency use authorization of its COVID-19 booster shot for all adults.

What You Need To Know

  • Pfizer and BioNTech asked the FDA to authorize booster doses of its COVID-19 vaccine for all adults 18 and older

  • Currently, booster doses of the Pfizer-BioNTech vaccine are available for people 65 and older and certain people 18 and up who are in high risk groups

  • A study released in October by the drugmakers found that a booster shot of their COVID-19 vaccine is 95.6% effective

  • The U.S. has administered more than 25 million booster doses as of Nov. 9, 2021, according to data from the U.S. Centers for Disease Control and Prevention; more than 16 million have been Pfizer-BioNTech booster shots

Currently, booster doses of the Pfizer-BioNTech vaccine are available for people 65 and older and certain people 18 and up who are in high risk groups.

The submission is based on the early data from a late-stage trial with more than 10,000 participants. Pfizer and BioNTech released findings from the clinical trial in October, which showed that a booster shot of their COVID-19 vaccine is 95.6% effective, even as the delta variant of the coronavirus was surging.

"These results provide further evidence of the benefits of boosters as we aim to keep people well-protected against this disease,” Pfizer Chairman and CEO Albert Bourla said in a news release at the time.

"Thus far, these are the first and only efficacy data disclosed from any randomized, controlled COVID-19 vaccine booster trial," the company wrote in Tuesday's release. "The adverse event profile was generally consistent with other clinical safety data for the vaccine, with no new safety concerns identified.""

The U.S. has administered more than 25 million booster doses as of Nov. 9, 2021, according to data from the U.S. Centers for Disease Control and Prevention. More than 16 million of those have been booster doses of the Pfizer-BioNTech COVID-19 vaccine.

While all three vaccines used in the U.S. continue to offer strong protection against severe COVID-19 illness and death, the shots’ effectiveness against milder infection can wane over time.

The Associated Press contributed to this report.