On Friday, Vinay Prasad—the Food and Drug Administration’s chief medical and scientific officer and its top vaccine regulator—emailed a stunning memo to staff that quickly leaked to the press. Without evidence, Prasad claimed COVID-19 vaccines have killed 10 children in the US, and, as such, he announced unilateral, sweeping changes to the way the agency regulates and approves vaccines, including seasonal flu shots.

On Wednesday evening, a dozen former FDA commissioners, who collectively oversaw the agency for more than 35 years, responded to the memo with a scathing rebuke. Uniting to publish their response in the New England Journal of Medicine, the former commissioners said they were “deeply concerned” by Prasad’s memo, which they framed as a “threat” to the FDA’s work and a danger to Americans’ health.

In his memo, Prasad called for abandoning the FDA’s current framework for updating seasonal flu shots and other vaccines, such as those for COVID-19. Those updates currently involve studies that measure well-characterized immune responses (called immunobridging studies). Prasad dismissed this approach as insufficient and, instead, plans to require expensive randomized trials, which can take months to years for each vaccine update.

Read full article

Comments

The top drug regulator at the Food and Drug Administration, Richard Pazdur, has decided to retire from the agency just three weeks after taking the leading position, according to multiple media outlets.

Pazdur, an oncologist who has worked at the FDA since 1999, was seen as a stabilizing force for an agency that has been mired in turmoil during the second Trump administration. He took over the role of leading the FDA’s Center for Drug Evaluation and Research on November 11, after the previous leader, George Tidmarsh, left the agency amid an investigation and a lawsuit regarding allegations that he used his position to exact petty revenge on a former business partner. In light of the scandal, one venture capital investor called the agency a “clown show.” Drug industry groups, meanwhile, called the FDA erratic and unpredictable.

Pazdur’s selection was seen as a positive sign by agency insiders, drug industry representatives, and patient advocacy groups, according to reporting by The Washington Post.

Read full article

Comments

When the federal vaccine committee hand-picked by anti-vaccine Health Secretary Robert F. Kennedy Jr. meets again this week, it will have yet another new chairperson to lead its ongoing work of dismantling the evidence-based vaccine recommendations set by the Centers for Disease Control and Prevention.

On Monday, the Department of Health and Human Services announced that the chairperson who has been in place since June—when Kennedy fired all 17 expert advisors on the committee and replaced them with questionably qualified allies—is moving to a senior role in the department. Biostatistician Martin Kulldorff will now be the chief science officer for the Office of the Assistant Secretary for Planning and Evaluation (ASPE), HHS said. As such, he’s stepping down from the vaccine committee, the Advisory Committee on Immunization Practices (ACIP).

Kulldorff gained prominence amid the COVID-19 pandemic, criticizing public health responses to the crisis, particularly lockdowns and COVID-19 vaccines. He was a co-author of the Great Barrington Declaration that advocated for letting the deadly virus spread unchecked through the population, which was called unethical by health experts.

Read full article

Comments

UPSIDE Foods just became the first company in the world to receive a "No Questions" letter from the FDA for cultivated meat, poultry, or seafood.

The post UPSIDE Foods Gets U.S. FDA Green Light for Cultivated Meat first appeared on Burn Blog.