Experts say strict new FDA protocol for vaccine approval is ‘dangerous and irresponsible’

The FDA's leading vaccine regulator, Dr. Vinay Prasad, has announced a new protocol for federal vaccine approvals, citing concerns over the deaths of at least 10 children after receiving Covid vaccines. The changes aim to re-examine annual flu-shot policies and consider limits on simultaneous vaccinations. Pharmaceutical manufacturers will need to provide more robust safety and efficacy data before approval. Pregnant women will face tighter restrictions on vaccine use. Dr. Paul Offit, a pediatrician, has criticized the approach as "dangerous and irresponsible," stating that extraordinary claims require extraordinary evidence. The new protocol is expected to make the vaccine approval process significantly more difficult.

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