The United States 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 the end of the series of primary vaccines.
Pfizer requested this EUA in late April, citing company data that showed a third dose of the vaccine increased antibodies to Omicron 36-fold in this age group.
“While it has been largely true that COVID-19 tends to be less severe in children than in adults, the omicron wave has seen more children falling ill with the disease and being hospitalized, and children may also experience longer-term effects, even after initially having mild illness,” FDA Commissioner Dr. Robert Califf said in a press release on Tuesday. “The FDA authorizes the use of a single dose of recall of the Pfizer-BioNTech COVID-19 vaccine for children 5-11 years old to provide continued protection against COVID-19.
4,500 children aged 5 to 11 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 United States Centers for Disease Control and Prevention have found that the effectiveness of two doses of Pfizer’s vaccine for children aged 5 to 12 years has significantly increased. dropped during the Omicron push, from 68% to about 12% versus infection. However, two doses continued to provide protection against more serious illnesses resulting in emergency care or hospitalization.
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 those 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 for unvaccinated people aged 12 and older.
The CDC’s Advisory Committee on Immunization Practices will meet on Thursday to discuss Covid-19 vaccine recalls. Although the agenda for the meeting has not been released, a vote is expected, according to the Federal Register.
Tuesday’s decision means anyone aged 5 and over is now eligible for at least one booster dose.
People 50 and older and people 12 and older with certain types of immunosuppression are eligible for two booster doses.
Moderna has also requested FDA clearance for a second Covid-19 booster shot for everyone 18 and older, but a decision has not yet been made on that request.