The FDA rejected Pfizer (PFE)/BioNTech's (BNTX) booster shot recommendation for the general public in order to place greater focus on inoculating the unvaccinated populations and collecting more data on booster shots, Meghan FitzGerald, adjunct associate professor of health policy and management at Columbia University, told Yahoo Finance Live.
Though the FDA rejected the booster for the general public by a large margin (16-2), the shot was endorsed unanimously for the elderly and immunocompromised populations in the U.S.
Three reasons were behind the decisions, FitzGerald said. “One, the evidence just wasn’t there. A lot of the evidence was in that elderly population which guided them,” she said. Data on the effectiveness and necessity of booster shots is not yet complete, she noted, and could take several more months before they may be recommended for the general public.
A general lack of data on the subject prompted the FDA to conclude that more research needs to be done with a broader range of subjects before the booster shots are to be administered beyond the most vulnerable populations.
Secondly, the vaccines already distributed to the public have been effective in reaching public health benchmarks. “The primary job was to prevent hospitalization and deaths, and we’re still seeing that at north of 90% for most of the vaccine. So I think they also felt that those at risk are really the group they wanted to focus on.”
The third, interrelated reason behind the FDA’s decision, according to FitzGerald, is the choice to place greater emphasis on vaccinating the unvaccinated populations, rather than improving the immunity of those who are already vaccinated.
Director of the National Institute of Allergy and Infectious Diseases (NIAID) Dr. Anthony Fauci supported the FDA’s decision not to authorize booster shots for the general population, citing less severe symptoms among younger people as a primary reason. As data emerges, the FDA can continue to further investigate, Fauci said.
The FDA also took into account the lack of vaccinations worldwide. “Less than one percent of [people in] low-income countries have been fully vaccinated,” FitzGerald said. “It’s a major problem.”
EAU by Halloween
On Monday morning, Pfizer and BioNTech announced that the first major trial of examining the safety and effectiveness of the vaccine among children from ages 5 to 11 produced positive results.
Children are generally less likely to become seriously ill when contracting the coronavirus, but they are still susceptible to the disease. Schools returning to in-person learning have taken extra precautions in order to reduce the spread of COVID, especially as we enter flu season and the threat of a ‘twindemic’ emerges.
“I think it’s major news,” FitzGerald said regarding the announcement. “Now, I don’t know what type of review this will go through, it will be either four or six weeks, but we could have emergency use authorization for this cohort by Halloween, which would be huge.”
“I think what we’re seeing is a transparent process, which is what the American public would like to see,” FitzGerald said.
Ihsaan Fanusie is a writer at Yahoo Finance. Follow him on Twitter @IFanusie.
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