Pfizer seeks approval from FDA to expand coronavirus booster eligibility to all adults
Pfizer announced yesterday that it is seeking authorization from the U.S. Food and Drug Administration (FDA) to allow anyone age 18 or older to be eligible for boosters of its coronavirus disease (COVID-19) vaccine, according to an article from NJ Advance Media.
This announcement comes amid concerns regarding the increased spread of COVID-19 with upcoming holiday travel and gatherings, according to the article.
Older individuals and those at increased risk have been eligible since September to receive their booster shots, though the FDA said it will quickly move to expand this eligibility to younger individuals if justified.
To make the case that expansion of booster shot eligibility is warranted, Pfizer is putting forward early results of a booster study involving 10,000 individuals, according to the article. The study has shown that the shot can restore protection against symptomatic infection to approximately 96 percent, even when factoring in the delta variant.
Those involved in the study were provided either a booster shot or a dummy shot, and after at least a week, researchers have so far found five cases of symptomatic COVID-19 among those who received the booster shot compared to 109 cases in those who got the dummy shot. The participants were a median of 11 months past receiving their last Pfizer vaccine dose.
In September, the FDA rejected allowing Pfizer booster shots to be available for all adults as the panel was not convinced that individuals who are young and healthy needed another dose, especially since much of the world’s population is still unvaccinated, according to the article.
Though, under the current policies, approximately 2 out of 3 vaccinated adults are still anticipated to become eligible for the Pfizer booster shot in the coming months.
Going forward, if the FDA authorizes Pfizer booster shots for all adults, the Centers for Disease Control and Prevention will ultimately make recommendations for how to use them, according to the article.