Vinay Prasad’s First Major Policy: Challenging Covid Vaccine ‘Dogma’ at FDA

Vinay Prasad, newly appointed director of the FDA’s biologics center (CBER), has introduced a major policy shift on Covid-19 vaccines—his first significant initiative since taking office4.

The new policy ends the previous 'one-size-fits-all' approach, restricting Covid-19 vaccine recommendations to people over 65 or those with at least one chronic health condition35.

For younger, healthy individuals, manufacturers must now conduct new placebo-controlled clinical trials to demonstrate efficacy and safety before receiving vaccine approval for this group35.

The rationale, as presented by Prasad and FDA Commissioner Marty Makary, is that increased population immunity and lower risk in younger demographics mean the original blanket recommendation is no longer justified35.

The policy is a departure from treating Covid-19 vaccines like flu vaccines, requiring more robust data before expanding recommendations to broader, lower-risk populations3.

Critics argue the move bypasses traditional scientific and regulatory processes, centralizing decision-making with FDA leadership without broader scientific consensus5.

This marks the clearest articulation yet of the FDA’s new direction, with Prasad directly challenging previous regulatory dogmas and aligning more closely with approaches taken by some other countries345.

Sources:

3. https://www.fiercepharma.com/pharma/fda-lays-out-stricter-covid-vaccine-policy-limits-approvals-older-and-high-risk-adults

4. https://endpts.com/vinay-prasad-makes-first-major-imprint-on-fda-with-new-vaccine-policy/

5. https://yourlocalepidemiologist.substack.com/p/covid-19-vaccines-what-just-happened