The anti-vaxxers over at Bob Kennedy's asylum for misunderstood quacks continue to ignore actual science and make disturbing national policy based on their "feelz." Watch for any scientists who speak out against this nonsense to be attacked as being part of a "coverup."Via the Bezos Post:
The nation’s top vaccine regulator on Friday laid out a stricter approach for federal vaccine approvals, citing his team’s conclusion that coronavirus vaccines had contributed to the deaths of at least 10 children, according to an internal Food and Drug Administration email obtained by The Washington Post.
Vinay Prasad, an FDA official whose approach to vaccine policy has been championed by Health Secretary Robert F. Kennedy Jr., told agency officials that the FDA will rethink its framework for annual flu shots, examine whether Americans should be receiving multiple vaccines at the same time and require vaccine makers to show far more data to prove the safety and value of their products. For instance, Prasad said that pneumonia vaccine makers must demonstrate that their products reduce pneumonia, rather than just generate antibodies to fight infections.
Does this anti-vaxxer idiot understand science? Ten deaths out of 100 million are not a red flag .
Prasad also wrote that the new approach means the agency will have strict requirements for authorizing new vaccines for pregnant women. He concluded his lengthy email by maintaining that he was open-minded about next steps.
“I remain open to vigorous discussions and debate,” Prasad wrote to his team, adding that staff who did not agree with the core principles of his new approach should submit their resignations.Collectively, Prasad’s plans would transform the FDA’s decades-old process of approving vaccines by compelling pharmaceutical companies to run far larger studies, likely slowing them down, said current and former agency staff and outside public health experts, some of whom spoke on the condition of anonymity to discuss internal FDA operations or comment on a developing situation. The approach could also have a chilling effect on the development of novel vaccines, because manufacturers will need to undertake sweeping new studies when seeking most new approvals — even for expanding the population who can get the shot, they said.
So if avian flu makes the long-dreaded leap to human-to-human transmission, you can forget about getting an effective vaccine in a timely manner.
Peter Hotez, the director of the Center for Vaccine Development at Texas Children's Hospital, said in a text message that he wanted to see Prasad’s statement about a link between covid-19 vaccines and children’s deaths supported with more data as well as information about any underlying health conditions.
“With almost one billion COVID immunizations administered to Americans during the pandemic, and perhaps close to 100 million for children and adolescents, it is conceivable that such a one in 10 million or 100 million event occurred,” such as a child’s death, Hotez wrote, later adding, “given the public health implications, this is not something one casually blurts out in an email.”
Not to mention that the database on which their conclusion is based is open to the public, and we've all people on social media claiming all kinds of obviously false whacky side effects.
The reports were submitted to the federal Vaccine Adverse Event Reporting System, which contains unverified reports of side effects or bad experiences of vaccines submitted by anyone, such as doctors, patients or even someone who sees a report on social media. CDC emphasizes that the database alone is not designed to assess whether a shot caused a death.
Prasad said that he then asked FDA staff to perform an analysis of 96 deaths between 2021 and 2024, concluding that “no fewer” than 10 are related.
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