FDA says Pfizer/BioNTech COVID-19 vaccine benefits children outweigh the risks Reuters

© Reuters. File photo: In this illustrated picture taken on March 19, 2021, you can see a vial labeled Pfizer-BioNTech coronavirus disease (COVID-19) vaccine. REUTERS/Dado Ruvic/Illustration

Michael Urman

New York (Reuters)-Scientists from the U.S. Food and Drug Administration (FDA) said on Friday that the potential benefits of vaccinating Pfizer/BioNTech COVID-19 in children aged 5 to 11 significantly outweigh the risks of rare cases of heart inflammation .

Earlier Friday, vaccine manufacturers stated that their vaccine was 90.7% effective against coronavirus in a clinical trial for children aged 5 to 11.

The details are in a briefing document to be released before the meeting of the external expert group scheduled to be held on Tuesday, which will vote on whether to recommend the FDA to approve injections targeted at young people.

If the FDA authorizes Pfizer/BioNTech to vaccinate children between 5 and 11 years of age, this will be the first COVID-19 vaccine for that age group, and it can be injected in the United States in early November.

Pfizer/BioNTech and Modern (NASDAQ:) The Inc vaccine has been linked to a rare case of heart inflammation called myocarditis, especially in young men.

FDA staff stated that assuming that the number of myocarditis cases observed in younger age groups is similar to the number of myocarditis cases observed in children aged 12 to 15 years, in most cases analyzed, COVID-19-related hospitalizations are prevented The number will exceed the number of hospitalizations related to myocarditis. .

Pfizer (New York Stock Exchange:) suggested in its own briefing document that the incidence of myocarditis in this age group may be lower than that observed in vaccinated 12 to 15-year-old children, partly because younger children were vaccinated The dose is lower.

Children aged 5 to 11 received two injections of 10 micrograms, which is one-third of the injection dose for people 12 years and older.

Pfizer stated in a briefing document submitted to the FDA that 16 children who received a placebo in the trial were infected with COVID-19, while 3 children were vaccinated.

Because in the 2,268-participant trial, the number of children vaccinated was more than twice that of placebo, which is equivalent to more than 90% of the effect.

The main purpose of Pfizer’s clinical trials in children aged 5 to 11 years is not to measure the efficacy of the virus.

Instead, it compared the amount of neutralizing antibodies induced by the vaccine in children with the response of older recipients in adult trials.

Based on these results, Pfizer and BioNTech stated last month that their COVID-19 vaccine caused a strong immune response in children. FDA staff stated that the vaccine meets the agency’s criteria for an immune response to children.

Extended test

Pfizer also said on Friday that it has expanded its clinical trials to improve its safety data, more than doubling the number of children recruited.

Pfizer said that the adverse event profile of the expanded group did not indicate any new safety issues with the vaccine. The company has previously stated that the safety profile of this age group is generally comparable to that of people aged 16 to 25.

The observation time for the second group of children was shorter. All of them received the second dose, and more than 70% of them were more than two weeks after the second dose.

The Pfizer/BioNTech vaccine has been authorized by U.S. regulatory agencies for people over 12 years of age, including full FDA approval for people aged 16 and over in August.

Approximately 190 million people in the United States have been vaccinated, and more than 11 million people between the ages of 12 and 17 have been vaccinated against Pfizer.

If the FDA approves vaccinations for children aged 5 to 11 years, a group of consultants from the Centers for Disease Control and Prevention (CDC) will meet on November 2 to 3 to advise the agency on how to vaccinate.

Most states wait for the CDC to sign the vaccine recommendation before starting the vaccination.



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