WASHINGTON / LONDON (IT BOLTWISE) – A top FDA official’s recent suggestions to tighten vaccine testing standards have sparked concern in the medical community. Experts warn that these changes could significantly limit access to life-saving vaccines.
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FDA official Vinay Prasad’s recent proposals to tighten vaccine testing standards have sparked concern in the medical community. Prasad, the director of the FDA’s Center for Biologics Evaluation and Research (CBER), suggested in an internal memo that future vaccines should only be approved after conducting randomized clinical trials. This requirement could significantly limit access to life-saving vaccines because such studies are expensive and time-consuming.
Particularly controversial is Prasad’s claim that COVID-19 vaccines have caused the deaths of 10 children, without providing any evidence. Experts like Paul Offit, an infectious disease specialist, are demanding that Prasad back up his claims with solid evidence. Linking a vaccine to an adverse event requires a high burden of evidence, including autopsy results and medical records that rule out other causes of death.
Prasad’s suggestions could particularly affect pregnant women, as they are typically not included in clinical trials. Jake Scott of Stanford University emphasizes that the FDA is instead relying on careful safety monitoring and measuring antibody levels to assess the effectiveness of vaccines. The requirement for randomized clinical trials could result in pregnant women being denied access to important vaccines.
The flu vaccines are also the focus of Prasad’s criticism. The annual adjustment of flu vaccines to new virus strains is based on predictions of which strains will circulate in the coming winter. Additional testing could jeopardize the timely availability of the vaccines. Experts like Dorit Reiss warn that Prasad’s proposals could significantly delay the development of new vaccines and endanger public health.
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