Infectious Disease

Pfizer, BioNTech Report Positive Phase 3 Data on COVID-19 Booster Vaccine

October 21, 2021

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Bourla is employed by Pfizer. Sahin is employed by BioNTech.

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Pfizer and BioNTech announced Thursday that a booster dose of their COVID-19 vaccine was safe and shown greater than 95% relative effectiveness compared to not having a booster, according to results from a Phase 3 study.

They were the first efficacy results of a randomized, controlled trial of a COVID-19 booster, the companies said.

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“These results are further evidence of the benefits of boosters as we want to protect people well from this disease,” said Pfizer Chairman and CEO Albert Bourla, DVM, PhD, it says in a press release. “In addition to our efforts to improve global access and uptake among unvaccinated people, we believe boosters must play a critical role in addressing the ongoing public health threat from this pandemic.”

The study looked at a booster dose of the vaccine in more than 10,000 people aged 16 years or older. According to the press release, people who had previously received the primary two-dose series were randomly assigned a 1: 1 booster dose or placebo approximately 11 months after the second dose.

The study showed that the booster dose “restored vaccine protection against COVID-19 to the high levels achieved after the second dose” – with an effectiveness of 95.6%. There were five cases of COVID-19 in the booster group compared to 109 in the placebo arm.

“These important data add to the evidence that suggests that a booster dose of our vaccine can help protect a broad population from this virus and its variants.” Ugur Sahin, MD, BioNTech’s CEO and Co-Founder said in the press release. “Based on these results, we believe that booster vaccinations, along with widespread global access to vaccines for all, could play an important role in containing the pandemic and returning to normal.”

The vaccine is fully approved in the United States for people 16 years of age and older, and is also available for children ages 12 to 15 with an emergency license. An FDA committee will meet next week to discuss extending this EEA to children ages 5-11.

Booster shots of the vaccine are already approved for immunocompromised patients and people aged 65 and over, people at high risk of severe COVID-19 and people who are at high risk of serious complications due to occupational or institutional exposure.

Pfizer and BioNTech plan to submit the new Phase 3 results for publication and make them available to the FDA, European Medicines Agency and other regulatory agencies worldwide as soon as possible.

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