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FDA rejected Pfizer (PFE) / BioNTech (BNTX) recall recommendation for the general public to place more emphasis on inoculating unvaccinated populations and collecting more recall data, Meghan FitzGerald , an assistant associate professor of health policy and management at Columbia University, told Yahoo Finance Live.
Although the FDA rejected the recall for the general public by a wide margin (16-2), the shot was unanimously approved for elderly and immunocompromised populations in the United States.
Three reasons were behind the decisions, FitzGerald said. “First, the evidence just wasn’t there. Much of the evidence was in this elderly population that guided them, ”she said. Data on the effectiveness and need for booster shots are not yet complete, she noted, and could take several months before they can be recommended for the general public.
A general lack of data on the subject has prompted the FDA to conclude that more research needs to be done with a wider range of subjects before booster shots are given beyond the most vulnerable populations.
Second, vaccines already distributed to the public have been effective in meeting public health benchmarks. “The main job was to prevent hospitalizations and deaths, and we’re still seeing that north of 90% for most vaccines. So I think they also felt that people 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 more emphasis on vaccinating unvaccinated populations, rather than improving the immunity of those who are already vaccinated.
The director of the National Institute of Allergy and Infectious Diseases (NIAID), Dr.Anthony Fauci, supported the FDA’s decision not to allow booster injections for the general population, citing less severe symptoms as the main reason. for young people. As more data emerges, the FDA may continue to investigate further, Fauci said.
The FDA has also taken into account the lack of vaccination around the world. “Less than one percent of [people in] low-income countries have been fully immunized, ”said FitzGerald. “It’s a major problem.
Halloween WATER
On Monday morning, Pfizer and BioNTech announced that the first major trial to examine the safety and effectiveness of the vaccine in children 5 to 11 years old produced positive results.
Children are generally less likely to become seriously ill when they contract the coronavirus, but they are still susceptible to the disease. Schools returning to in-person learning have taken extra precautions to reduce the spread of COVID, especially as we enter flu season and the threat of a ‘twinemia’ emerges.
“I think this is major news,” FitzGerald said of the announcement. “Now, I don’t know what type of review it will go through, it will be 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, what the American public would like to see,” FitzGerald said.
Ihsaan Fanusie is a writer at Yahoo Finance. Follow him on twitter @IFanusia.
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