Debate On Vaccine Safety Reaches Policy Stage - FDA Broadens Review Into Covid-19 Shot Risks In Adults
Could a controversial figure's challenge to vaccine policies unravel decades of public health progress? As the FDA dives deeper into COVID-19 vaccine safety, questions arise about the potential impact on public trust and the future of immunization practices.
According to Bloomberg, the U.S. Food and Drug Administration (FDA) has expanded a safety inquiry into COVID-19 vaccines to determine whether the shots may have contributed to deaths among adults.
The review initially appeared focused on pediatric cases.
The shift comes as Robert F. Kennedy Jr., the new U.S. Health and Human Services secretary challenges longstanding federal vaccine recommendations and calls broader immunization practices into question.
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The FDA's inquiry spans multiple divisions within the agency and marks an unusual step at a time when scientific consensus maintains that the vaccines are safe and have delivered substantial public-health benefits.
FDA's Move Could Raise Vaccine Safety Concerns
Kennedy, however, has repeatedly criticized both the safety and effectiveness of the shots, contributing to renewed scrutiny as federal agencies reassess ongoing vaccine policies.
The "FDA is doing a thorough investigation, across multiple age groups, of deaths potentially related to Covid vaccines," a spokesperson told Bloomberg on Tuesday.
Most recently, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted 8 to 3 to rescind the universal recommendation for a hepatitis B birth-dose vaccine for infants born to hepatitis B surface antigen–negative mothers.
The COVID-19 franchises of Pfizer Inc. (NYSE:PFE) and Moderna Inc. (NASDAQ:MRNA) were already under pressure as pandemic-era demand fell sharply. Fewer Americans have opted for annual boosters, further straining revenue expectations for both companies.
Public Trust In Vaccines
Last month, the Center for Biologics Evaluation and Research Director Vinay Prasad had reportedly unveiled a sweeping plan to tighten how vaccines win federal approval after an internal safety review raised new alarms about COVID-19 shots, the Washington Post reported, citing an internal email.
The memo outlines tougher standards for vaccine makers and asserts without evidence that at least 10 child deaths followed COVID-19 vaccinations.
Some public-health experts warn that the FDA's broadened review, paired with Kennedy's rhetoric, risks sowing additional uncertainty among the public.
Michael Kinch, chief innovation officer at Stony Brook University and a specialist in drug development, told Bloomberg the move could fuel unnecessary doubts.
What Certain Studies Say
An analysis published in July estimated that COVID-19 vaccinations averted 2.5 million deaths globally from 2020 to 2024.
There were isolated reports in scientific literature of deaths linked to post-vaccination myocarditis.
Myocarditis is an inflammation of the heart muscle. One such case in the U.S. was documented in the New England Journal of Medicine.
Another study in the same journal reviewing 5.1 million vaccinated Israelis found that most myocarditis cases were mild, though a small number were severe and one resulted in death.
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