Pfizer, BioNTech report positive phase 3 data on COVID-19 booster shot
Pfizer and BioNTech said Thursday that a booster dose of their COVID-19 vaccine was safe and demonstrated a relative efficacy of more than 95% compared with not receiving a booster shot, according to findings from a phase 3 trial.
They were the first efficacy results from a randomized, controlled trial of a COVID-19 booster shot, the companies said.
“These results provide further evidence of the benefits of boosters as we aim to keep people well-protected against this disease,” Pfizer Chairman and CEO Albert Bourla, DVM, PhD, said in a press release. “In addition to our efforts to increase global access and uptake among the unvaccinated, we believe boosters have a critical role to play in addressing the ongoing public health threat of this pandemic.”
The trial assessed a booster shot 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 in a 1:1 ratio to receive a booster dose or a placebo around 11 months after the second dose.
The study demonstrated that the booster dose “restored vaccine protection against COVID-19 to the high levels achieved after the second dose” — to an efficacy of 95.6%. There were five cases of COVID-19 in the booster group compared with 109 in the placebo arm.
“These important data add to the body of evidence suggesting that a booster dose of our vaccine can help protect a broad population of people from this virus and its variants,” Ugur Sahin, MD, CEO and co-founder of BioNTech, said in the release. “Based on these findings we believe that, in addition to broad global access to vaccines for everyone, booster vaccinations could play an important role in sustaining pandemic containment and a return to normalcy.”
The vaccine is fully approved in the United States for people aged 16 year or older, and also available under an emergency use authorization for children aged 12 to 15 years. An FDA committee will meet next week to discuss expanding that EUA to include kids aged 5 to 11 years.
Booster shots of the vaccine are already authorized for immunocompromised patients and people aged 65 years or older, people at high risk from severe COVID-19 and people who face a high risk for serious complications based on occupational or institutional exposure.
Pfizer and BioNTech said they plan to submit the new phase 3 results for publication and share them with the FDA, European Medicines Agency, and other regulatory agencies globally as soon as possible.
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