On May 20, the federal government announced it will require vaccine manufacturers to conduct additional studies when updating COVID-19 vaccines for the general population. This decision alters previous guidelines where annual updates did not require supplementary testing, similar to the flu vaccine protocol. However, for high-risk groups, such as the elderly and immunocompromised individuals, the traditional approval process remains unchanged. Dr. Vinay Prasad emphasized that these changes aim to ensure the vaccine maintains its effectiveness across different demographics, representing around 100 million to 200 million Americans.
"This is a tremendously broad category; this effectively means 100 million to 200 million Americans, those with the most favorable benefit-to-harm balance, will be covered by these approvals."
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