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FDA advisory panel to review COVID-19 vaccine strategy

By ramontomeydw // 2025-05-12

• The FDA's VRBPAC will discuss recommendations for updated COVID-19 vaccines, including which variants to target and whether boosters should be promoted. Their advice, though non-binding, may influence fall/winter immunization efforts.
• New FDA appointees, including Dr. Marty Makary and Dr. Vinay Prasad, have publicly questioned aspects of COVID-19 vaccine policies. The agency faces scrutiny after resignations of key officials, like former CBER Director Dr. Peter Marks, who reportedly clashed with Health Secretary Robert F. Kennedy Jr. on vaccine policy.
• Kennedy advocates removing COVID-19 vaccines from the CDC's childhood schedule, aligning with polls showing public opposition to routine boosters for healthy kids. The FDA's stricter stance (e.g., delaying Novavax and Moderna vaccines for more data) signals a shift toward tighter regulatory scrutiny.
• The FDA may move away from its influenza-like model (annual updates without new trials) toward requiring placebo-controlled studies, slowing approvals but increasing safety oversight. The CDC is also considering a risk-based approach instead of universal recommendations.
• The May 22 meeting could redefine U.S. COVID-19 vaccination strategies amid evolving science, public skepticism, and debates over mandates. New leadership and regulatory changes will shape future vaccine policies.

The Food and Drug Administration (FDA) will convene a panel of experts in a critical meeting on May 22 to discuss recommendations for the next round of Wuhan coronavirus (COVID-19) vaccines. The virtual meeting of the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) will weigh in on which COVID-19 variant should be targeted in updated booster shots, or whether boosters would be promoted at all. While the VRBPAC's advice isn't binding, it could shape immunization efforts for the fall and winter seasons. The May 22 meeting also comes amid significant leadership changes in the FDA. Dr. Marty Makary was named as the new head of the agency, while Dr. Vinay Prasad was named as the new director of the FDA's Center for Biologics Evaluation and Research (CBER). Incidentally, both Makary and Prasad have publicly questioned aspects of the government's COVID-19 vaccine approach. (Related: FDA names scrutiny advocate Dr. Vinay Prasad to lead vaccine division amid calls for transparency.) The FDA's handling of COVID-19 vaccines has faced mounting criticism, particularly after the resignations of key officials. These officials include former CBER Director Dr. Peter Marks, who reportedly clashed with Health Secretary Robert F. Kennedy Jr. over vaccine policies. Kennedy, a health freedom advocate critical of vaccine mandates, has pushed for reforms – including a potential removal of COVID-19 shots from the Centers for Disease Control and Prevention's (CDC) childhood immunization schedule. His stance aligns with broader public sentiment as recent polls suggest many Americans oppose routine COVID-19 boosters for healthy children.

Novavax and Moderna in limbo as FDA shifts to stricter standards

The upcoming meeting also follows delays in the approval of Novavax's protein-based vaccine, which the FDA has asked to undergo additional clinical trials – a departure from previous regulatory flexibility. Moderna has similarly faced hurdles, with the agency requesting more data on its experimental flu-COVID combination vaccine. These developments signal a stricter approach under the new leadership, a shift that analysts say could lead to more restrictive vaccine recommendations. The FDA has historically followed an influenza-like model for COVID-19 vaccines, updating formulations annually without requiring new clinical trials. But recent demands for placebo-controlled studies suggest a pivot toward more rigorous standards. Critics argue this could slow vaccine availability, while supporters contend it ensures greater safety scrutiny. Meanwhile, the CDC is considering narrowing its universal COVID-19 vaccine recommendation – potentially shifting to a risk-based approach. Such a move would mark a significant departure from earlier policies, reflecting evolving scientific understanding and public skepticism. As the FDA prepares for its May 22 meeting, the outcome could redefine the future of COVID-19 vaccination in the U.S. With new leadership in place and growing debate over vaccine mandates, the agency’s decisions will be closely watched. Watch this clip of a Moderna executive telling the FDA's VRBPAC that babies should be injected with its COVID-19 vaccine at the soonest. This video is from the SecureLife channel on Brighteon.com.

More related stories:

CDC considers scaling back universal COVID-19 vaccine recommendations. FDA reconsiders COVID-19 booster approvals, with Makary emphasizing the need for "good data." FDA's 'Vaccine Czar' – Peter Marks – betrayed Americans, destroyed medical ethics and human lives. Sources include: Reuters.com BiopharmaDive.com TheEpochTimes.com Brighteon.com

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