First FDA-approved COVID booster for children ages 5-11: Shot

First-year student Rihanna Chihuaque, 7, was vaccinated with the COVID-19 vaccine at the Arturo Velasquez Institute in Chicago last November.

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First-year student Rihanna Chihuaque, 7, was vaccinated with the COVID-19 vaccine at the Arturo Velasquez Institute in Chicago last November.

Scott Olson / Getty Images

On Tuesday, the Food and Drug Administration approved the first COVID-19 vaccine booster for children ages 5-11.

With this approval, all children in that age group who received a second dose at least 5 months ago are eligible for a third dose of the Pfizer-BioNTech vaccine.

The two companies have shown that third shots are safe, can significantly increase antibody levels, combat weakened immunity, and provide additional protection against viruses containing the more contagious Omicron mutants. Requested approval based on a small study.

Until now, boosters have only been available to children and adults over the age of 12.

“COVID-19 tends to be less severe in children than adults, but Omicron waves have seen more children get sick and hospitalized, and even after the first follow-up. A mild illness that may experience longer-term effects. ” In the statement..

“The FDA allows children aged 5 to 11 years to receive a single booster dose of the Pfizer-BioNTech COVID-19 vaccine to provide continued protection against COVID-19,” Califf said. .. “Vaccination continues to be the most effective way to prevent COVID-19 and its serious consequences and is safe.”

It is still unclear how much demand there is for boosters.Less than One-third of children aged 5 to 11 years are fully vaccinated and only about one-quarter of adolescents. I received a booster.

Many doctors and parents say it is important to provide as much protection as possible to children, especially as the number of people infected with the virus has increased again and fewer people are wearing masks. I want approval.

“Since the vaccine was licensed to children up to the age of 5 in October 2021, new data show that the efficacy of the vaccine against COVID-19 has declined after the second dose of the vaccine in all licensed populations. We suggest that we do, “said Peter Marks, director of the FDA Center. In his statement, for the evaluation and research of biologics.

“The FDA has known and potential benefits of a single booster immunization of the Pfizer-BioNTech COVID-19 vaccine for children aged 5 to 11 years at least 5 months after completing the primary series. The booster effect helps provide continuous protection against COVID-19 in this and older age groups, “Marks said.

However, others are skeptical that the two shots still provide strong protection against serious illness and death, and how much additional protection the third shot provides, or It is unknown how long it will last.

The FDA did not ask external advisors to comment on the decision, as the Commission said it had previously discussed the issue and no new questions were raised.

Advisor to the Centers for Disease Control and Prevention on Vaccine Practice Meet on thursday And it is expected to discuss the implementation of booster immunization for this age group.

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