U.S. FDA advisers again Pfizer/BioNTech COVID-19 vaccine for youngsters By Reuters


© Reuters. FILE PHOTO: This illustration image dated March 19, 2021 shows a vial labeled with the Pfizer BioNTech vaccine for coronavirus disease (COVID-19). REUTERS / Dado Ruvic

By Manas Mishra and Michael Erman

(Reuters) – A panel of experts voted overwhelmingly on Tuesday to recommend that the U.S. Food and Drug Administration recommend the Pfizer Inc (NYSE 🙂 and BioNTech SE (NASDAQ 🙂 COVID-19 vaccine for children ages 5-11, where the benefits of vaccination outweigh the risks.

Approval for this age group would be an important regulatory move to reach approximately 28 million children for vaccination, most of whom go back to school for personal study.

The vaccine could be available for the younger age group as early as next week. The FDA is not required to follow the advice of its outside experts, but it usually does.

If the FDA approves the vaccinations for this age group, an advisory panel from the United States Centers for Disease Control and Prevention will meet next week to make a recommendation on how to use the vaccine. The CDC director will make the final call.

The companies have stated that their vaccine showed 90.7% effectiveness against the coronavirus in a clinical study involving children ages 5-11.

While children are relatively less likely to get sick or die of COVID-19 compared to adults, some develop complications and infections in unvaccinated children have increased due to the easily transmitted Delta variant of the coronavirus.

“To me the question is pretty clear,” said Dr. Amanda Cohn, a pediatric vaccine expert with the CDC and a voting panel member. “We don’t want children to die of COVID, even if there are far fewer children than adults, and we don’t want them to stay in intensive care.”

Pfizer and BioNTech are seeking approval for a lower dose of the vaccine of 10 micrograms in children compared to 30 micrograms for people 12 years and older. The shot has been approved for children ages 12 to 15 since May, after being approved for those aged 16 and over in December.

The consultants paid close attention to the frequency of an inflammation of the heart called myocarditis, which has been linked to and with both Pfizer / BioNTech Modern (NASDAQ 🙂 Vaccines, especially in young men.

If it turns out that the number of myocarditis cases in the younger age group is similar to that of 12-15 year olds, the number of hospitalizations prevented due to COVID-19 would exceed the number of hospitalizations prevented due to myocarditis in most of the scenarios analyzed, FDA reviewers said in documents prepared ahead of Tuesday’s meeting.

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