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Pfizer, BioNTech COVID-19 Vaccine Booster Dose 95.6% Effective
In the randomized, Phase 3 clinical trial, there were five cases of the coronavirus in the COVID-19 vaccine booster dose and 109 cases in the placebo group.
Pfizer and BioNTech recently announced that their COVID-19 vaccine booster was 95.6 percent effective in individuals compared to placebo.
The randomized, controlled Phase 3 trial enrolled over 10,000 individuals 16 years of age and older. In the trial, all patients completed the primary two-dose series of the Pfizer- BioNTech vaccine and then received a 30 microgram booster dose of the vaccine or placebo.
There were five cases of COVID-19 in the booster group and 109 cases in the placebo group during the study period.
Notably, the safety profile was generally consistent with other clinical safety data for the vaccine, with no safety concerns identified.
The time between the second dose of the vaccine and the booster dose or placebo was nearly 11 months. Researchers conducted a follow-up after about two and a half months. These are the first efficacy results 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,” Albert Bourla, chairman and chief executive officer of Pfizer, said in the announcement.
“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,” Bourla continued.
In September, FDA amended the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to allow for a single booster six months after completing the primary series.
FDA based its decision on the totality of the available scientific evidence and the deliberations of its advisory committee of scientific and public health experts.
Pfizer and BioNTech plan to submit detailed results from the trial for peer-reviewed publication.
Additionally, the companies also plan to share these data with FDA, the European Medicines Agency, and other regulatory agencies around the world as soon as possible.
