Pfizer announced Tuesday it is asking the U.S. Food and Drug Administration to authorize booster doses of its COVID-19 vaccine for all adults, ages 18 and older. The request comes a month and a half after the FDA authorized boosters for seniors and other higher-risk adults.
The company says new data from a large clinical trial of more than 10,000 fully vaccinated people found that a booster dose was over 95% effective against COVID-19 compared to individuals who were fully vaccinated but had not received a booster dose. A press release issued by Pfizer said that during the study period, "there were 5 cases of COVID-19 in the booster group, and 109 cases in the non-boosted group." The company also says the efficacy of the booster dose was consistent across different ages and racial and ethnic groups.
The request is similar to one made by Pfizer in August, when it asked federal regulators to amend its full license to allow a booster dose for individuals 16 and older. But when the request was considered and debated by the agency's outside advisers in September, many raised concerns that there was insufficient evidence to suggest that vaccine-induced immunity was waning in younger populations, particularly against severe disease.