Pharmaceutical giant Pfizer said on Tuesday that it has requested United States health regulators in the Food and Drug Administration for an emergency use authorisation for its COVID-19 booster shot for all individuals above the age of 18.
Older Americans and other groups particularly vulnerable to the virus have had access to a third dose of the Pfizer and BioNTech vaccine since September this year. However, the Food and Drug Administration has said it would move quickly to expand boosters to younger ages if the need arises.
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The results of a booster study, which was conducted with a cohort of 10,000 individuals, will be submitted to the United States Food and Drug Administration in an attempt to expand the eligibility criteria of COVID vaccine booster shots.
While all three vaccines used in the United States continue to offer strong protection against severe COVID-19 illness and death, the shots’ effectiveness against milder infection can wane over time, according to reports from Associated Press.
The booster shot of Pfizer’s coronavirus vaccine is able to restore protection against the disease to 96%, according to the statements on Tuesday citing the results of the study. The results were recorded while the Delta variant of the virus was surging across the United States.
Side effects were similar to those seen with the company’s first two shots.
A median of 11 months after their last Pfizer vaccination, trial participants were given either a third dose or a dummy shot, according to reports from Associated Press.
Researchers tracked any infections that occurred at least a week later, and so far have counted five cases of symptomatic COVID-19 among booster recipients compared to 109 cases among people who got dummy shots.
If the FDA authorizes Pfizer boosters for all adults, the Centers for Disease Control and Prevention then will make recommendations for how to use them.
(With AP inputs)