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FDA Panel Limits COVID Booster Recommendations to Elderly, High Risk

The US Food and Drug Administration (FDA) Advisory Board has overwhelmingly voted against recommending an extensive COVID-19 vaccine booster program to all US adults at this time. Instead, the panel unanimously recommended boosters to high-risk groups or people over the age of 65.

The White House announced in mid-August Planning for a large COVID-19 vaccine booster program Start in late September. The plan was to provide a third vaccination to all Americans over the age of 16.

The anomalous announcement preceded a formal recommendation from an independent FDA or CDC panel convened to determine the safety or efficacy of the vaccine booster program. On Friday, September 17, the FDA’s Vaccine and Related Biopharmaceutical Advisory Board (VRBPAC) met to review the proposal and vote against the government’s extensive booster program recommendations.

The panel spent hours reviewing the data on the COVID-19 booster, and both Pfizer and Israeli scientists insisted that all adults at this time receive a wide range of third doses. Israeli data, which began administering booster shots to all adults 16 years and older in late July, suggest that a third dose significantly improves the reduced defense against COVID-19 infection.

However, VRBPAC eventually opposed recommending boosters to all adults, with a majority of 16 in favor and only two against. The two main factors cited in the decision are the lack of safety data for the third vaccination in young adults and the current vaccine protocol remains significantly effective for severe illness, hospitalization, and death. It was strong evidence to show that.

“The third dose is probably beneficial.” VRBPAC panelist said Offer Levy, a scientist at Harvard University. “It’s already true about immunocompromised conditions. In my opinion, it’s beneficial to the elderly and may eventually be adapted to the general public. I think it’s still there when it comes to data. not.”

The Commission unexpectedly voted for another booster proposal during the meeting. In a unanimous vote, the Commission recommended that boosters be given to people over the age of 65 and to certain high-risk categories.

At the next CDC Immunization Implementation Advisory Board meeting, it will be clear who these high-risk groups are. It may cover people with medical vulnerabilities, but it may also include certain professions such as health care workers and teachers.

The VRBPAC decision is just a recommendation, but it is unlikely that the FDA will not follow the advice. Anthony Fauci, White House Chief Medical Advisor, said VRBPAC’s recommendations were “good” but “not the end of the story.” Fauci, who co-signed the August White House announcement calling for an extensive booster program, said the issue of a third vaccination was more likely to be a question of when than it was. ..

“I don’t think they made a mistake, but people need to be aware that data comes in literally daily and weekly, and they will continue to see this literally in real time.” Fauci told CNN Following the decision. “Ultimately, the proper regimen for protection, optimal protection, and protection durability may not only take 3-4 weeks after prime and boost, but […]

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