Booster given to individuals who received the companies primary two-dose series
Pfizer, Inc. and BioNTech SE announced Thursday that topline results from a Phase III trial found that a 30-microgram booster dose of the companies’ vaccine showed relative vaccine efficacy of 95.6% in individuals who previously received Pfizer/BioNTech Primary Two. Was. -Dose range, when compared to those not receiving boosters.
The trial involved more than 10,000 people who were 16 years of age or older, and Pfizer said in a news release that the booster doses given to participants improved vaccine protection against COVID-19 “as compared to the second dose.” later restored to the high level achieved.”
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Individuals were randomized to receive either a 30-microgram booster dose — the same dose as in the primary series — or a placebo.
The midpoint between the second dose of the Pfizer/BioEntech vaccine and the administration of a booster dose or placebo was approximately 11 months.
Symptomatic COVID-19 incidence was measured from at least seven days after booster or placebo, with a median follow-up time of approximately two and a half months.
Five cases of COVID-19 were reported in the booster group and 109 cases were reported in the non-boosted group.
The mean age of the participants was 53 years and subgroup analyzes showed that the efficacy of the booster was consistent regardless of age and other factors such as gender, race, ethnicity and concomitant conditions.
The adverse event profile, Pfizer noted, was “generally consistent with other clinical safety data for the vaccine, with no safety concerns.”
The result, the company said, is the first from any randomized, controlled COVID-19 vaccine booster trial.
“These results provide further evidence of the benefits of boosters as we aim to keep people well protected against this disease,” Pfizer CEO Albert Boerla said in a statement.
Pfizer and BioNTech plan to submit results from the trial for peer-reviewed publication, as well as share the data with the US Food and Drug Administration (FDA), the European Medicines Agency and other regulatory agencies.
In September, a Pfizer/BioNTech booster dose was approved by the FDA for individuals 65 and older, individuals 18 to 64 years of age at high risk of severe COVID-19, and 18 to 64 years of age. was authorized for emergency use. With frequent institutional or occupational exposure to the virus.
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On Wednesday, a booster dose was also authorized by the FDA for emergency use for eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine.