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.
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.