Pfizer and BioNTech announced Thursday that a booster shot of its coronavirus vaccine was 95.6% effective at preventing symptomatic cases of COVID-19 in a Phase 3 clinical trial.
“In the trial, a booster dose administered to individuals who previously received the Pfizer-BioNTech primary two-dose series restored vaccine protection against COVID-19 to the high levels achieved after the second dose, showing a relative vaccine efficacy of 95.6% when compared to those who did not receive a booster,” the drugmakers said in a news release. “These are the first efficacy results from any randomized, controlled COVID-19 vaccine booster trial.”
At least 10,000 trial participants ages 16 and older received a booster dose, which had a “favorable safety profile,” the companies said. The efficacy data was compiled “during a period when Delta was the prevalent strain” of the virus, according to the release.
“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 statement. “In addition to our efforts to increase global access and uptake among the unvaccinated, we believe boosters have a critical role to play in addressing the ongoing public health threat of this pandemic. We look forward to sharing these data with health authorities and working together to determine how they can be used to support the rollout of booster doses around the world.”
The companies said they plan to submit the study results to a peer-reviewed publication and share data with the U.S. Food and Drug Administration, as well as regulatory agencies around the world.
The news came about a month after the FDA approved the Pfizer-BioNTech booster for emergency use in individuals ages 65 and older, people ages 18 to 64 who are at high risk of severe COVID-19, and people ages 18 to 64 whose “frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19,” the agency said in a Sept. 22 news release.
On Wednesday, the FDA also approved the mixing of COVID-19 shots for boosters, and OK’d booster shots for Moderna and Johnson & Johnson vaccine.
According to the Centers for Disease Control and Prevention, about 57.1% of the U.S. population is fully vaccinated against COVID-19. About 5.9% of those individuals have received a booster dose, the agency reported Wednesday.
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