FDA, vaccine approvals
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A senior Food and Drug Administration official on Friday said the agency will change its vaccine approval process, alleging that Covid-19 vaccination resulted in the deaths of 10 children.
The top vaccine chief at the Food and Drug Administration sent out a memo saying the FDA will seek a stricter review and approval protocol for vaccine trials.
The head of the Food and Drug Administration's vaccine division claimed in a leaked email that “at least 10 children" died from COVID-19 vaccination, using that to justify major vaccine regulatory changes.
Former US public health officials are sounding alarms about significant changes being made to the country’s vaccine policy under the Trump administration.
Former FDA Commissioners Warn New Vaccine Policies Could Undermine Longstanding Regulatory Framework
In their NEJM commentary, the former FDA heads stated, “We are deeply concerned by sweeping new FDA assertions about vaccine safety and proposals that would undermine a regulatory model designed to ensure that vaccines are safe, effective, and available when the public needs them most.”
Pregnant people have a higher risk of severe disease and death from COVID, so making it harder for them to get vaccinated would jeopardize their health and that of their fetus, Permar says. The same is true for flu, which is why doctors recommend that all pregnant people get a flu shot.
Myocarditis is a known — but small — side effect of the mRNA Covid vaccines from Pfizer and Moderna, information that federal agencies have discussed openly since 2021.
A senior FDA official issued a memo linking at least 10 child deaths to the COVID-19 vaccine without providing supporting data, and federal regulators now say future vaccines will face stricter evidence requirements,
17hon MSNOpinion
Dr. Gottlieb: FDA is systemically trying to dismantle components of the vaccine approval process
Former FDA Commissioner Dr. Scott Gottlieb joins 'Squawk Box' to discuss concerns over the FDA's sweeping changes to how the U.S. handles vaccinations, impact on the public trust in vaccines, degradation at the FDA,