A dozen prior leaders of the U.S. Food and Drug Administration — appointed by Republicans and Democrats alike — issued a scathing denunciation of new FDA assertions casting doubt on vaccine safety. The former officials assert that the agency’s plans to revamp how life-saving vaccines for flu, COVID-19, and other respiratory diseases are handled — outlined in an internal FDA memo last week — would “disadvantage the people the FDA exists to protect, including millions of Americans at high risk from serious infections.”
The proposed new directives are framed by the officials, former FDA commissioners and acting commissioners, as not being mere adjustments or coherent policy updates but rather representing a major shift in the FDA’s understanding of its role. The internal memo from FDA vaccine chief Dr. Vinay Prasad, while not publicly released, has been confirmed for authenticity by a source, claiming — without evidence — that COVID-19 vaccines caused the deaths of ten children. They also outlined planned changes in vaccine handling, suggesting that FDA staff who disagreed should resign.
Among Prasad’s proposals were revisions on how yearly flu shot updates are managed and an increased focus on “the benefits and harms of administering multiple vaccines simultaneously.” The narrative presented by vaccine skeptics regarding multiple shots potentially overwhelming children’s immune systems has often been rebuffed by scientific research showing no substantial concerns.
These planned changes are coming at a time when Health Secretary Robert F. Kennedy Jr., known for leading anti-vaccine sentiment, is reshaping federal vaccine policies, including ousting a committee that advised the CDC on vaccine recommendations. In looking to assert a different stance, Kennedy dismissed Susan Monarez from the CDC chief position just 29 days into her tenure due to disagreements on vaccine policy.
Wednesday’s statements from the former FDA leaders also countered Prasad’s claims regarding child deaths related to COVID-19 vaccines, arguing the surveillance system reporting such incidents lacks the necessary medical data to substantiate any claimed link. They noted previous analyses conducted by scientists led to differing conclusions and underscored the substantial evidence showing that COVID-19 vaccines safeguard children from severe disease and hospitalization.
Ultimately, the former officials warned that these recent proposals could reject established scientific standards for evaluating vaccine updates tailored to new virus strains, hinder the pace of innovation in vaccine development, and diminish public transparency around these critical health decisions.
The proposed new directives are framed by the officials, former FDA commissioners and acting commissioners, as not being mere adjustments or coherent policy updates but rather representing a major shift in the FDA’s understanding of its role. The internal memo from FDA vaccine chief Dr. Vinay Prasad, while not publicly released, has been confirmed for authenticity by a source, claiming — without evidence — that COVID-19 vaccines caused the deaths of ten children. They also outlined planned changes in vaccine handling, suggesting that FDA staff who disagreed should resign.
Among Prasad’s proposals were revisions on how yearly flu shot updates are managed and an increased focus on “the benefits and harms of administering multiple vaccines simultaneously.” The narrative presented by vaccine skeptics regarding multiple shots potentially overwhelming children’s immune systems has often been rebuffed by scientific research showing no substantial concerns.
These planned changes are coming at a time when Health Secretary Robert F. Kennedy Jr., known for leading anti-vaccine sentiment, is reshaping federal vaccine policies, including ousting a committee that advised the CDC on vaccine recommendations. In looking to assert a different stance, Kennedy dismissed Susan Monarez from the CDC chief position just 29 days into her tenure due to disagreements on vaccine policy.
Wednesday’s statements from the former FDA leaders also countered Prasad’s claims regarding child deaths related to COVID-19 vaccines, arguing the surveillance system reporting such incidents lacks the necessary medical data to substantiate any claimed link. They noted previous analyses conducted by scientists led to differing conclusions and underscored the substantial evidence showing that COVID-19 vaccines safeguard children from severe disease and hospitalization.
Ultimately, the former officials warned that these recent proposals could reject established scientific standards for evaluating vaccine updates tailored to new virus strains, hinder the pace of innovation in vaccine development, and diminish public transparency around these critical health decisions.
