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FDA advisory panel declines to support widespread COVID-19 vaccine boosters

Does unanimously endorse booster for seniors and high-risk people

A U.S. Food and Drug Administration advisory panel voted Friday to endorse COVID-19 booster shots for high-risk demographics such as those age 65 and older but declined to support offering booster vaccine doses to all eligible U.S. residents.

The panel of third-party experts voted 16-2 against a plan endorsed by President Joe Biden's administration to begin offering third doses to eligible people later this month, arguing that targeting booster vaccination efforts is more appropriate.

The panel also voted unanimously to support booster doses for people aged 65 and older or those at high risk to contract the virus and develop serious illness.

Federal officials that had endorsed the booster shots plan had argued that - given the propensity for the high level of immunity offered by the two-dose Moderna and Pfizer-BioNTech vaccines to reduce over time while still preventing serious illness and death -- the third doses would be necessary to continue battling new variants of the virus and prevent hospitals from being overrun across the country.

Even if the panel had approved the booster shot plan, approval from officials with the FDA and the Centers for Disease Control and Prevention would still be required before doses could go into arms.

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Last month, FDA and CDC officials approved the administration of booster doses for people who have weakened immune systems due to an assortment of factors such as people who are being treated for cancer, organ transplant recipients and people with HIV.

The plan to offer booster shots to all fully vaccinated people also received support last month from a swath of officials within the federal Health and Human Services Agency.

The group included CDC Director Dr. Rochelle Walensky, FDA Acting Commissioner Dr. Janet Woodcock, U.S. Surgeon General Dr. Vivek Murthy and National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci.

"Our top priority remains staying ahead of the virus and protecting the American people from COVID-19 with safe, effective, and long-lasting vaccines especially in the context of a constantly changing virus and epidemiologic landscape," the group said in its joint statement.

The administration of booster doses in western countries has drawn the ire of the World Health Organization, which has argued that many non-wealthy countries across the world have yet to even receive their initial vaccine doses.

"Because manufacturers have prioritized or been legally obliged to fulfill bilateral deals with rich countries willing to pay top dollar, low-income countries have been deprived of the tools to protect their people," WHO Director-General Tedros Ghebreyesus said in a news briefing earlier this month.

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FDA advisory panel declines to support widespread COVID-19 vaccine boosters

Does unanimously endorse booster for seniors and high-risk people

by /

Uploaded: Sun, Sep 19, 2021, 5:30 pm

A U.S. Food and Drug Administration advisory panel voted Friday to endorse COVID-19 booster shots for high-risk demographics such as those age 65 and older but declined to support offering booster vaccine doses to all eligible U.S. residents.

The panel of third-party experts voted 16-2 against a plan endorsed by President Joe Biden's administration to begin offering third doses to eligible people later this month, arguing that targeting booster vaccination efforts is more appropriate.

The panel also voted unanimously to support booster doses for people aged 65 and older or those at high risk to contract the virus and develop serious illness.

Federal officials that had endorsed the booster shots plan had argued that - given the propensity for the high level of immunity offered by the two-dose Moderna and Pfizer-BioNTech vaccines to reduce over time while still preventing serious illness and death -- the third doses would be necessary to continue battling new variants of the virus and prevent hospitals from being overrun across the country.

Even if the panel had approved the booster shot plan, approval from officials with the FDA and the Centers for Disease Control and Prevention would still be required before doses could go into arms.

Last month, FDA and CDC officials approved the administration of booster doses for people who have weakened immune systems due to an assortment of factors such as people who are being treated for cancer, organ transplant recipients and people with HIV.

The plan to offer booster shots to all fully vaccinated people also received support last month from a swath of officials within the federal Health and Human Services Agency.

The group included CDC Director Dr. Rochelle Walensky, FDA Acting Commissioner Dr. Janet Woodcock, U.S. Surgeon General Dr. Vivek Murthy and National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci.

"Our top priority remains staying ahead of the virus and protecting the American people from COVID-19 with safe, effective, and long-lasting vaccines especially in the context of a constantly changing virus and epidemiologic landscape," the group said in its joint statement.

The administration of booster doses in western countries has drawn the ire of the World Health Organization, which has argued that many non-wealthy countries across the world have yet to even receive their initial vaccine doses.

"Because manufacturers have prioritized or been legally obliged to fulfill bilateral deals with rich countries willing to pay top dollar, low-income countries have been deprived of the tools to protect their people," WHO Director-General Tedros Ghebreyesus said in a news briefing earlier this month.

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