A senior official at the Food and Drug Administration (FDA) has proposed significant changes to the vaccine approval process, alleging that Covid-19 vaccinations have resulted in the deaths of 10 children.Dr Vinay Prasad, the FDA's chief medical and scientific officer, made these claims in an internal memo obtained by CNN, stating that "healthy young children who faced tremendously low risk of death were coerced" into receiving the vaccine through mandates from the Biden administration.
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cnn.comPrasad's memo did not provide specific details regarding the deaths or the methodology behind the FDA's conclusions, but he referenced "an initial analysis" that examined 96 deaths and linked 10 to Covid-19 vaccination.
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cnn.comHe argued that Covid-19 was never highly lethal for children, comparing its effects to those of other respiratory viruses that do not have annual vaccines.
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cnn.comIn light of this analysis, Prasad indicated that the FDA would implement a new approval process requiring more rigorous evidence of safety and efficacy before vaccines can be marketed.This includes stricter requirements for vaccines intended for pregnant women and trials for pneumonia vaccines that must demonstrate a reduction in disease rather than simply producing adequate antibodies.
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cnn.comThe proposed changes could lead to longer study durations, potentially delaying vaccine availability.
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cnn.comPrasad expressed a willingness to discuss these changes internally, urging staff who disagree with the new principles to resign.
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cnn.comThis initiative aligns with the views of Health and Human Services Secretary Robert F.Kennedy Jr, a long-time critic of vaccines who has previously questioned their effectiveness and safety.Kennedy has taken steps to limit access to Covid-19 vaccines, particularly for healthy children and pregnant women, and has reshaped the CDC's advisory committee to include members with similar views.
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cnn.comThe FDA is expected to present data linking Covid vaccines to 25 deaths in children at an upcoming meeting of the Advisory Committee on Immunization Practices (ACIP), which plays a crucial role in determining vaccine access and recommendations.
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nbcnews.comHowever, experts have raised concerns about the validity of claims based on the Vaccine Adverse Event Reporting System (VAERS), which collects unverified reports of adverse events linked to vaccines.
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nbcnews.comCritics argue that VAERS data cannot definitively prove causation, as it requires comprehensive studies to establish a direct link between vaccination and adverse outcomes.
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nbcnews.comDespite the ongoing investigations, numerous studies have shown that Covid vaccines are safe for children and significantly reduce the risk of hospitalization and death.
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nbcnews.comcnbc.comFDA Commissioner Marty Makary has stated that the agency is conducting an "intense investigation" into the reported deaths, but he has not provided specific data linking these fatalities to the vaccine.
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nbcnews.comcnbc.comThe FDA plans to release a report in the coming weeks, which may clarify the agency's findings.
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cnbc.comIn the meantime, the FDA recently approved updated Covid-19 vaccines but limited their use to individuals with high-risk health conditions, such as asthma or obesity, while revoking emergency authorization for Pfizer's vaccine for children under 5 years old.
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pbs.orgThis decision has raised concerns among medical professionals and parents who fear it may create barriers to vaccination for many children.
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pbs.orgThe evolving landscape of vaccine policy, marked by heightened skepticism and calls for stricter regulations, reflects a significant shift in the US approach to immunization during the pandemic.As the FDA and CDC navigate these changes, the implications for public health and vaccine accessibility remain to be seen.
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pbs.orgcnbc.comThe ongoing debate over vaccine safety and efficacy underscores the importance of transparent communication and rigorous scientific investigation in addressing public concerns about immunization, particularly for vulnerable populations such as children.
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fda.govIn conclusion, the FDA's proposed changes to the vaccine approval process, driven by claims of adverse effects from Covid-19 vaccinations, signal a pivotal moment in US public health policy.The outcomes of these discussions will likely have lasting impacts on vaccine accessibility and public trust in immunization programs.
