FDA says benefits outweigh risks of Pfizer/BioNTech COVID-19 vaccine in children By Reuters – News Couple

FDA says benefits outweigh risks of Pfizer/BioNTech COVID-19 vaccine in children By Reuters

© Reuters. FILE PHOTO: A vial carrying the coronavirus disease (COVID-19) vaccine from Pfizer-Biontech is seen in this illustrative photo taken on March 19, 2021. REUTERS/Dado Rovik/Illustration

Written by Michael Erman

NEW YORK (Reuters) – The potential benefits of giving the Pfizer/BioNTech COVID-19 vaccine to children ages 5 to 11 clearly outweigh the risks of rare cases of heart infection, U.S. Food and Drug Administration (FDA) scientists said on Friday. .

Earlier on Friday, vaccine makers said the vaccine showed 90.7% efficacy against the coronavirus in a clinical trial for children ages 5 to 11.

The details were in brief documents released ahead of a meeting of the panel of external experts scheduled to vote on Tuesday on whether to recommend the Food and Drug Administration to license the shots for the younger age group.

If the FDA allows the Pfizer/BioNTech vaccination for children ages 5 to 11, it will be the first age-group COVID-19 vaccine and the shots could be available in the United States in early November.

Both Pfizer / BioNTech and modern (NASDAQ 🙂 Inc vaccines have been linked to a rare case of heart inflammation called myocarditis, especially in young adults.

FDA staff said, assuming that the number of myocarditis cases observed in the younger age group would be similar to those seen in the 12 to 15-year-old group, the number of COVID-19-related hospitalizations prevented from Hospitalization would exceed the number of cases of inflammation-related myocarditis in most of the scenarios analyzed. .

Pfizer (NYSE: 🙂 noted in its briefing that the rate of myocarditis in this age group was likely to be lower than what was observed in 12-15-year-olds, in part because younger children were given a lower dose.

Children 5 to 11 years of age were given two injections of 10 mcg, one-third of what was given to people 12 years of age or older.

In a document briefing submitted to the US Food and Drug Administration, Pfizer said 16 children in the trial who received a placebo received COVID-19, compared to three who were vaccinated.

Since more than twice as many children in the trial with 2,268 participants were given the vaccine compared to placebo, this equates to an efficacy of more than 90%.

Pfizer’s clinical trials in those aged 5 to 11 were not primarily designed to measure efficacy against 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 findings, Pfizer and BioNTech said last month that their COVID-19 vaccine had caused a strong immune response in children. FDA staff said the vaccine met the agency’s standards for the immune response it elicits in children.

Expanded experience

Pfizer also said Friday that it has expanded its clinical trial to improve its safety data, more than double the number of children enrolled.

According to Pfizer, the adverse event profile in the expanded group did not indicate any new safety concerns from the vaccine. The company had previously said that the safety profile in the age group is generally comparable to that of the 16-25 age group.

The second group of children was observed for a shorter period. All received their second dose and it was more than 70% more than two weeks after the second dose.

The Pfizer/BioNTech vaccine already has a US regulatory license for people at least 12 years old, including full FDA approval in August for those 16 and older.

About 190 million people in the United States have been fully vaccinated, including more than 11 million ages 12-17 who received the Pfizer vaccine.

If the FDA allows vaccinations for children ages 5 to 11, a group of advisors at the U.S. Centers for Disease Control and Prevention (CDC) will meet on November 2-3 to make recommendations to the agency on how to give the vaccines.

Most states wait for the CDC to sign vaccine recommendations before they begin giving vaccines.

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