FDA Says Advantages Outweigh Dangers For Pfizer / BioNTech COVID-19 Vaccine In Youngsters – North Denver Information

U.S. Food and Drug Administration (FDA) scientists said Friday that the likely benefits of giving the Pfizer / BioNTech COVID-19 vaccine to 5-11 year olds significantly outweighed the risks of rare cases of heart inflammation.

On the previous Friday, vaccine makers announced that their vaccination showed 90.7% effectiveness against the coronavirus in a clinical study involving children ages 5-11.

The details were made public in briefing papers released ahead of a meeting of a panel of external experts due to vote Tuesday on whether the FDA recommends approving the shots for the young age group.

If the FDA approves Pfizer / BioNTech vaccination for children ages 5-11, it would be the first COVID-19 vaccine for the age group, and vaccinations could be available in the US in early November.

Both Pfizer / BioNTech and Moderna Inc vaccines have been linked to rare cases of heart inflammation called myocarditis, particularly in young men.

FDA staff said that assuming the number of myocarditis cases observed in the younger age group were similar to that of 12-15 year olds, the number of COVID-19-related hospitalizations prevented in most of the scenarios analyzed Number of hospital admissions caused by myocarditis.

Pfizer suggested in its own briefing documents that the rate of myocarditis in the age group was likely lower than vaccinated 12-15 year olds, in part because the younger children received a lower dose.

The 5-11 year olds received two syringes of 10 micrograms, a third of what was given to people 12 years and older.

Sixteen children in the study who received a placebo got COVID-19, versus three who were vaccinated, Pfizer said in briefing documents submitted to the FDA.

Since more than twice as many children in the study with 2,268 participants received the vaccine than placebo, this corresponds to an effectiveness of more than 90%.

Pfizer’s clinical study in 5-11 year olds wasn’t primarily aimed at measuring effectiveness against the virus. Instead, it compared the amount of neutralizing antibodies induced in the children by the vaccine to the response of older recipients in their adult study.

Based on these results, Pfizer and BioNTech announced last month that their COVID-19 vaccine elicited a robust immune response in the children. FDA staff said the vaccine met the agency’s criteria for the immune response it elicited in the children.

Extended trial version

Pfizer also said Friday that it had expanded its clinical trial to improve its safety data and more than doubled the number of children enrolled.

According to Pfizer, the side effect profile in the extended group did not suggest any new vaccine safety concerns. The company had previously announced that the safety profile in the age group was generally similar to that of 16-25 year olds.

The second cohort of children was followed for a shorter time. All had received their second dose and more than 70% were more than two weeks after the second dose.

The Pfizer / BioNTech vaccine already has US approval for people 12 years and older, including full FDA approval in August for people 16 and older.

Around 190 million people in the United States are fully vaccinated, including more than 11 million ages 12 to 17 who received the Pfizer vaccine.

If the FDA approves the vaccine for 5-11 year olds, a group of advisors from the U.S. Centers for Disease Control and Prevention will meet on November 2-3 to give the agency recommendations on how to administer the vaccines submit.

Most states are waiting for the CDC to make vaccine recommendations before they begin giving shots.

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