"Prasad said the agency plans to re-examine annual flu-shot policies, consider limits on simultaneous vaccinations, and require more robust safety and efficacy data from pharmaceutical manufacturers before approval. The internal memo reportedly stated that a recent review determined at least 10 children had died after and because of receiving a Covid vaccine. Prasad noted that these deaths appeared tied to myocarditis, or inflammation of the heart muscle."
"This is a profound revelation, Prasad wrote in the memo to staff members. For the first time, the US FDA will acknowledge that Covid-19 vaccines have killed American children. He also wrote that new rules would impose tight restrictions on vaccines for pregnant women, marking another significant change in the agency's approval framework. I remain open to vigorous discussions and debate, Prasad wrote, reportedly adding that staff who did not agree with the core principles of his new approach should submit their resignations."
The FDA vaccine regulator Vinay Prasad signaled a far stricter approach to federal vaccine approvals, citing a review that reportedly linked Covid vaccines to the deaths of at least ten children. The agency plans to re-examine annual flu-shot policies, consider limits on simultaneous vaccinations, and demand more robust safety and efficacy data from manufacturers before approval. The memo associated the reported deaths with myocarditis and proposed tighter restrictions on vaccines for pregnant women. Prasad reportedly invited vigorous debate but urged staff who disagreed with core principles to resign. The memo reportedly lacked identifying details and did not name manufacturers.
Read at www.theguardian.com
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