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FDA’s Bold Move: Pfizer’s EUA Revoked

In a surprising twist, the FDA has pulled the emergency use authorization for Pfizer’s Covid vaccine aimed at children. This decision, articulated by CBER Director Vinay Prasad, raises eyebrows and questions about the regulatory landscape surrounding pediatric vaccinations.

As the FDA tightens its grip on vaccine approvals, Prasad’s insights reveal a cautious approach to public health. The decision may stem from emerging data that suggests a need for more robust evidence before endorsing such a critical intervention in younger populations. With the agency now favoring a more selective approval process, it’s clear that the stakes are high—not just for Pfizer, but for the entire pharmaceutical ecosystem. This move could signal a shift in how regulatory bodies evaluate the safety and efficacy of vaccines in vulnerable demographics.

As we navigate this complex terrain, one must ponder: are we witnessing a necessary recalibration of trust in vaccine safety, or is this a step back in the fight against Covid-19?

Source: endpoints.news