FDA expands eligibility for Pfizer COVID-19 booster to children 5-11
The decision was based on an analysis of immune response data, as well as the impacts of the Omicron variant.
Photo: Jasmin Merdan/Getty Images
Under emergency use authorization, the U.S. Food and Drug Administration has expanded eligibility for the Pfizer-BioNTech COVID-19 booster vaccine to children 5 to 11 years old. People in that age group are now cleared for a single booster dose of the shot at least five months after they've completed the primary two-dose series.
FDA Commissioner Dr. Robert M. Califf said via statement that while COVID-19 tends to be less severe in children, the Omicron variant has resulted in more kids getting sick and being hospitalized, which in part is why the agency expanded booster eligibility.
The decision was also based on FDA's analysis of immune response data in a subset of children from the ongoing, randomized placebo-controlled trial that supported the October 2021 authorization of the primary series in this age group.
Antibody responses were evaluated in 67 study participants who received a booster dose seven to nine months after completing a two-dose primary series of the vaccine. The antibody level against the SARS-CoV-2 virus one month after the booster dose was increased compared to before the booster dose.
WHAT'S THE IMPACT
Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said that since the agency authorized the vaccine for children as young as 5 in October 2021, the data suggests that vaccine effectiveness wanes after the second dose.
A recent study in the New England Journal of Medicine found that protection from a second booster dose of Pfizer's offering begins to wane after about four weeks, though its effectiveness against severe illness lasts longer.
Protection against infection from the virus plateaued about four weeks after the fourth shot was administered. Among those who didn't get the second booster, the infection rate was about twice as high.
By the eighth week after the shot, however, the added protection all but evaporated, with the infection rate almost identical between those patients and the ones who had foregone a second booster.
More encouraging was the second booster's lasting effectiveness against severe COVID-19. A month after getting the shot, the rate of severe disease was 3.5 times lower in that group than in those who had only received three shots. That protection still held after about six weeks.
The safety of a single booster dose of the vaccine in the 5-11 age group was assessed in about 400 children who received a booster dose at least five months after completing a two-dose primary series. The most commonly reported side effects were pain, redness and swelling at the injection site, as well as fatigue, headache, muscle or joint pain and chills and fever.
The FDA did not hold a meeting of its Vaccines and Related Biological Products Advisory Committee on the decision, as the agency previously convened the committee for extensive discussions regarding the use of booster doses of COVID-19 vaccines.
After review of Pfizer's EUA request, the FDA concluded that the request did not raise questions that would benefit from additional discussion by committee members. The FDA will make relevant documents available on its website regarding the authorization.
THE LARGER TREND
The last time the FDA expanded booster eligibility to a new age group was in January, when it authorized the shot for children 12 to 15 years old.
The agency determined that the protective health benefits of a single booster dose of the Pfizer shot outweighed the potential risks in those who fell under that age group. The boosters, according to the FDA, provide continued protection against COVID-19 and the associated consequences that may occur, such as hospitalization and death.
Previously, the FDA authorized a third primary series dose for use as part of the primary immunization series in individuals 12 years old and older. The potential effectiveness of an additional dose in children ages 5 to 11 was extrapolated from data in adults.
In March, the FDA authorized both Pfizer and Moderna to give a second booster dose of their COVID-19 vaccines to individuals aged 50 and older and to those who are immunocompromised.
Twitter: @JELagasse
Email the writer: jeff.lagasse@himssmedia.com
