Reuters. File photo: A vial labeled with the Pfizer-Bioentech Coronavirus Disease (COVID-19) vaccine is shown in this illustrated photo taken March 19, 2021. REUTERS / Dado Ruvic / Illustration
By Michael Erman
NEW YORK (Reuters) – Scientists at the US Food and Drug Administration (FDA) said Friday that the potential benefits of the Pfizer / Bioentech COVID-19 vaccine for 5- to 11-year-olds are significantly higher than the risk of rare heart disease. .
Earlier Friday, vaccine makers said their shot showed 90.7% efficacy against the coronavirus in clinical trials of children aged 5 to 11 years.
Whether the FDA will recommend approving shots for the younger age group was in a briefing document released before a meeting of a panel of outside experts scheduled to vote on Tuesday.
If the FDA approves the Pfizer / BioNTech vaccine for children ages 5 to 11, it will be the first COVID-19 vaccine for ages and shots will be available in the United States in early November.
Both Pfizer / BioNTech and Modern (NASDAQ 🙂 Ink vaccines have rarely been linked to myocarditis, especially in adolescents.
FDA staff estimates that the number of myocarditis cases between the ages of 12 and 15 is higher than the number of preventable COVID-19s in most cases. .
Pfizer (NYSE 🙂 in its own briefing document suggested that the rate of myocarditis in the age group may be lower than in vaccinated 12- to 15-year-olds, because younger children were given lower doses.
Children aged 5 to 11 years were given two shots of a 10-microgram dose, one-third of which was given to those 12 years of age or older.
Sixteen children who received a placebo in the trial received COVID-19, vs. three who were vaccinated, Pfizer said in a briefing on documents submitted to the FDA.
Because more than twice as many children were vaccinated than placebo in the 2,268-participating trials, which is equivalent to a better efficacy than 90%.
Clinical trials of 5 to 11-year-old Pfizer were not initially designed to measure efficacy against the virus.
Instead, it compared the amount of vaccine-induced neutral antibody in children to the response of adult recipients to their adult tests.
Based on these results, Pfizer and BioNTech said last month that their COVID-19 vaccine has created a strong immunity in children. FDA staff say the vaccine meets the agency’s standards for the immunity that children develop.
Pfizer added Friday that it has expanded its clinical trials to improve its safety data, more than doubling the number of children enrolled.
According to Pfizer, the adverse event profile in the expanded group did not suggest any new safety concerns from the vaccine. The agency had previously said that the age group safety profile is generally comparable to 16 to 25 year olds.
The second group of children has been observed for a short time. All of them received their second dose and more than 70% of the doses were more than two weeks later.
The Pfizer / BioNTech vaccine already has U.S. regulatory approval for those under 12 years of age, 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 people between the ages of 12 and 17 who have received the Pfizer vaccine.
If the FDA approves the vaccine for 5 to 11-year-olds, a team of advisers from the US Center for Disease Control and Prevention (CDC) will recommend to the agency on November 2-3 how shots should be handled. .
Most states wait for the CDC to sign vaccine recommendations before they start handling shots.