The US Food and Drug Administration has granted emergency use authorization for a booster dose of Pfizer/BioNTech’s Covid-19 vaccine for children ages 5 to 11 at least five months after completion of the primary vaccine series.
Pfizer requested this EUA at the end of April, citing company data that showed that a third vaccine dose raised Omicron-fighting antibodies by 36 times in this age group.
“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer term effects, even following initially mild disease,” FDA Commissioner Dr. Robert Califf said in a news release Tuesday. “The FDA is authorizing the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age to provide continued protection against COVID-19.
4,500 children ages 5 through 11 years of age participated in the Pfizer/BioNTech Covid-19 vaccine trial and no new safety issues were observed, Pfizer said in a statement.
Studies from the New York State Department of Health and the US Centers for Disease Control and Prevention found that the effectiveness of two doses of Pfizer’s vaccine for children ages 5 to 12 dropped substantially during the Omicron surge, falling from 68% to about 12% against infection. However, two doses continued to provide protection against more severe illness resulting in urgent care or hospitalizations.
Public health officials have urged Americans to stay up to date with their Covid-19 vaccinations, including all recommended booster doses, as the best way to protect themselves and the people around them.
A recent CNN analysis of CDC data showed that for those who were fully vaccinated and boosted in February, the risk of dying from Covid-19 was 20 times lower than it was for unvaccinated people 12 and older.
The CDC’s Advisory Committee on Immunization Practices will meet Thursday to discuss Covid-19 vaccine boosters. Though the agenda for the meeting has not been posted, a vote is scheduled, according to the Federal Register.
Tuesday’s decision means anyone 5 and older is now eligible for at least one booster dose.
Those who are 50 and older and people 12 and older who have certain kinds of immunocompromise are eligible for two booster doses.
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Moderna has also requested FDA authorization for a second Covid-19 booster shot for everyone 18 and older, but a decision has yet to be made regarding that request.