A Food and Drug Administration (FDA) advisory panel this week recommended emergency use approval for booster doses of both Moderna’s and Johnson & Johnson’s COVID-19 vaccine.
On Thursday, the FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend that certain at-risk people receive a booster dose of Moderna’s coronavirus vaccine at least six months after their initial two doses of the Moderna vaccine.
The Moderna booster dose is only 50 micrograms, half the size of the two initial 100-microgram doses individuals are given when they first receive the vaccine.
The groups who could benefit from a Moderna booster shot are people age 65 and older and people ages 18 to 64 who are either at high risk of severe illness or whose exposure to COVID-19 in their jobs put them at risk for complications or severe illness, the committee said.
However, some of the committee’s 19 members appeared reluctant to vote for the Moderna booster shot, pointing out that the data on the potential benefits of a booster dose is “not perfect.”
“The data are not perfect but these are extraordinary times and we have to work with imperfect data,” said Dr. Eric Rubin, a professor at the Harvard T.H. Chan School of Public Health who is also editor-in-chief of the New England Journal of Medicine, CNN reported.
“We can’t afford to have health care workers, even if not sick, be positive and infected and have to stay home from work because in parts of the country there’s a shortage of health care workers and there’s burnout everywhere,” remarked Dr. Stanley Perlman, a University of California San Diego professor of pediatrics.
On Friday a day later, the same FDA advisory committee voted unanimously to recommend booster shots of Johnson & Johnson’s one-dose COVID-19 vaccine.
The Johnson & Johnson recommendation was broader than the panel’s decision on Moderna. The panel recommended booster shots for everyone 18 and older who received their initial Johnson & Johnson shot at least two months ago.
Studies have found that Johnson & Johnson’s one-shot vaccine is less effective than the Pfizer and Moderna vaccines.
The FDA must issue an official decision in order for either of the advisory committee’s recommendations to be adopted.
Last month, the FDA approved a booster dose of Pfizer’s COVID-19 vaccine for the same at-risk groups listed in the advisory committee’s recommendation for the Moderna booster shot.
“Today’s action demonstrates that science and the currently available data continue to guide the FDA’s decision-making for COVID-19 vaccines during this pandemic,” Acting FDA Commissioner Janet Woodcock said of the Pfizer decision, adding that the Pfizer booster shot would be allowed for groups like health care workers, teachers, grocery workers, and those in homeless shelters or prisons.
In June, Moderna asked the FDA to approve its vaccine for 12 to 17-year-olds. However, the FDA has now decided to delay approval to review whether the vaccine increases the risk of myocarditis, a rare inflammatory heart condition, in younger people.
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