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Pfizer, BioNTech Report 95.6% Efficacy for Covid Vaccine Booster

'These are the first efficacy results from any randomized, controlled Covid-19 vaccine booster trial.' Pfizer and BioNTech said.
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Pfizer Inc.  (PFE) - Get Pfizer Inc. Report and partner BioNTech  (BNTX) - Get BioNTech SE Sponsored ADR Report said Thursday that a trial of their Covid vaccine booster was 95.6% effective.

They reported “top-line results from a Phase 3 randomized, controlled trial evaluating the efficacy and safety of a 30-µg booster dose of the Pfizer-BioNTech Covid-19 vaccine in more than 10,000 individuals 16 years of age and older,” the companies said.

“In the trial, a booster dose administered to individuals who previously received the Pfizer-BioNTech primary two-dose series restored vaccine protection against Covid-19 to the high levels achieved after the second dose, showing a relative vaccine efficacy of 95.6% when compared to those who did not receive a booster.

“These are the first efficacy results from any randomized, controlled Covid-19 vaccine booster trial.”

The companies plan to give the data to the Food and Drug Administration, the European Medicines Agency and other regulators worldwide.

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Shares of Pfizer, the New York health-care group, recently traded at $42.56, down 0.6%. BioNTech, Mainz, Germany, was at $281.71, up 4.6%.

Last month, the FDA approved the Pfizer-BioNTech booster for emergency use for people 65 and older and people 18 through 64 at high risk.

On Wednesday, the FDA authorized a booster dose for emergency use by people who have completed a primary vaccination with a different authorized provider.

Earlier this month, Pfizer and BioNTech requested emergency use authorization from the FDA to administer their vaccine to children aged 5 to 11.

Pfizer is the only fully approved FDA vaccine for individuals 16 and over, and is also authorized for emergency use in children aged 12 to 15.