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The FDA Say NO to Booster Shots , Except for Over 65 High Risk Individuals

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the staff of the Ridgewood blog

Washington DC, The Food and Drug Administration advisory committee on Friday rejected a proposal to distribute booster shots of Pfizer and BioNTech’s Covid-19 vaccines to the general public, paring back those plans to unanimously recommend the third shots to people age 65 and older and other vulnerable Americans.

“It’s likely beneficial, in my opinion, for the elderly, and may eventually be indicated for the general population. I just don’t think we’re there yet in terms of the data,” said Dr. Ofer Levy, a vaccine and infectious disease specialist at Boston Children’s Hospital.

The panel voted 16-2 against distributing the vaccines to Americans 16 and older, before unanimously embracing an alternate plan to give boosters to older Americans and those at a high risk of suffering from severe illness if they get the virus. That’s previously included people with diabetes, heart disease, obesity and other so-called comorbidities.

NJ State Senator Holly Schepisi, ” FYI, the FDA voted against booster shots today for anyone other than severely immunocompromised, those with active cancer receiving treatment such as chemotherapy, organ transplant recipients or those over age 65. It appears that there is quite the disconnect between the Biden Administration’s announcement that boosters were needed for all and the scientific data.”

The Biden Administration initially announced plans for booster doses after unpublished data from a study in Israel suggested that the Pfizer-BioNTech vaccine demonstrated reduced efficacy months after the initial inoculation. Pfizer’s company leadership echoed these claims, suggesting that a booster dose would be able to counteract waning immunity in individuals who received their full vaccine regimen months earlier. Pfizer released additional data from a booster dose campaign in Israel, in which a third dose increased effectiveness against symptomatic COVID-19 back to approximately 95%, similar to the initial efficacy after 2 doses demonstrated in clinical trials. Moderna also released data suggesting that an increase in breakthrough cases made the idea of booster doses more reasonable. Despite these early claims, Moderna’s president released a statement questioning the necessity of future vaccine doses. Documents released by the FDA earlier this week in advance of the VRBPAC meeting showed that FDA scientists questioned the necessity of booster doses, considering that the vaccines are still exhibiting high levels of protection against severe disease and death in the US. Several FDA scientists published a commentary in The Lancet arguing that there is not enough evidence to indicate waning protection from SARS-CoV-2 vaccination.

One thought on “The FDA Say NO to Booster Shots , Except for Over 65 High Risk Individuals

  1. Headline is missing an important “and.” Over 65 AND high-risk individuals.

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