Pfizer-BioNTech booster shots are now authorized by the FDA for people 65 and older and for certain high-risk adult populations
The Food and Drug Administration authorized a booster dose Wednesday of Pfizer and BioNTech's Covid-19 vaccine for people 65 and older and for certain high-risk adult populations.
It notably excludes 16- and 17-year-olds — who Pfizer had included in its booster application to the agency — in an apparent nod to the lack of data on the safety of an additional dose for younger people. Pfizer's and Moderna's messenger RNA vaccines have been associated with rare cases of myocarditis, an inflammation of the heart muscle, after vaccination. The side effect typically occurs in males 30 and younger.
“This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day,” she said. “As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed.”
An FDA-requested analysis by Pfizer shows that the incidence of Covid in July and August, when the Delta variant became the dominant strain in the U.S., was higher among trial participants who were fully vaccinated earlier in the study compared to those who completed their initial series later. The Biden administration had hoped to begin a broader booster rollout this week, after top federal health officials endorsed the idea of offering third dose of the Pfizer-BioNTech and Moderna Covid-19 vaccines to most adults on that timetable. But in the weeks after that announcement, scientists in and out of the federal government pushed back against the idea, arguing there was not convincing evidence for the plan.
Deutschland Neuesten Nachrichten, Deutschland Schlagzeilen
Similar News:Sie können auch ähnliche Nachrichten wie diese lesen, die wir aus anderen Nachrichtenquellen gesammelt haben.
FDA backs Pfizer COVID-19 boosters for seniors and those at high riskThe FDA authorized Pfizer booster doses for Americans who are 65 and older, younger people with underlying health conditions and those in jobs that put them at high-risk for COVID-19.
Weiterlesen »
FDA Authorizes Pfizer COVID Vaccine Booster Shots For Americans 65 And OlderPfizer said a third shot would restore the effectiveness of its COVID-19 vaccine to about 95%.
Weiterlesen »
Pfizer Study of Covid-19 Vaccine in Pregnant Women Delayed by Slow EnrollmentPfizer wanted to study its Covid-19 vaccine in pregnant women, but then the shots became widely available; “It’s hard to enthusiastically recommend the study when you’ve got a vaccine out there,” says one doctor
Weiterlesen »
Smaller COVID vaccine doses may protect children as well as full doses in adults: PfizerPfizer just released its first safety data about COVID-19 vaccines for children ages 5 to 11, reassuring parents that a safe and effective vaccine soon could be available for those younger than 12.
Weiterlesen »
U.S. CDC advisers could vote on Pfizer COVID-19 vaccine booster on ThursdayThe CDC's Advisory Committee on Immunization Practices (ACIP) is meeting on Sept 22-23 to discuss which Americans should get the third vaccine shot, should it be authorized for use by the Food and Drug Administration. Pfizer has asked the FDA to approve the third shot for all people aged 16 and over, but a panel of outside advisors to the FDA last Friday said there was only evidence for a shot being needed by people aged 65 and older.
Weiterlesen »