STAT+: Pharmalittle: We’re reading about FDA’s Prasad defending his plans, a Merck setback in Germany, and more

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still shaping up, but we hope to catch up on our reading, nap extensively, and hold another listening party with Mrs. Pharmalot, where the rotation will likely include this, this, this, this and this. And what about you? There are holidays approaching, so this may be an opportunity to bolster the economy and order a few gifts. You could plan an end-of-year getaway. This is also a good time to finish your tax planning. Or you could simply curl up in front of the telly and watch a few moving picture shows. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon …

Vinay Prasad, the Food and Drug Administration’s top vaccines regulator, blamed “misleading media narratives” for the escalating criticism of his leadership amid turmoil and plummeting morale at the agency, STAT reports. His remarks, delivered Thursday at a New York investor conference closed to the public and press, came a day after 12 former FDA commissioners published an urgent warning that his proposed changes to vaccine policy would have dire consequences for American public health. Prasad, director of the Center for Biologics Evaluation and Research as well as the agency’s chief medical and scientific officer, defended his plan, which would require manufacturers to conduct longer and larger studies before updating vaccines, as a matter of modernizing FDA policy. “We’re not talking about throwing the baby out with the bathwater,” Prasad said of the proposal, which was detailed in a leaked memo to agency staff last month.

The future of children’s vaccines is on the agenda at today’s meeting of federal vaccine advisers, who are reviewing the childhood schedule and informing their discussion is a leader in the effort to limit access to vaccines and raise doubts about their safety and effectiveness, who has petitioned regulators to remove access to polio and hepatitis B vaccines, and represented people with vaccine injury claims, STAT explains. Aaron Siri, an attorney with ties to Health and Human Services Secretary Robert F. Kennedy Jr., will lead the committee through a sweeping, 76-slide presentation that broadly addresses the childhood vaccine schedule, according to an agenda for the meeting and a copy of the slides uploaded to the website of the Advisory Committee on Immunization Practices. In them, he invites the committee to consider revisiting “prior recommendations made without robust data” and requiring “robust trial and, when possible, post-licensure safety data.”

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