Oct. 13, 2025
| Today’s news and insights for biopharma leaders
NOTE FROM THE EDITOR
The shift has been sudden and significant.
Since the confirmation of Robert F. Kennedy Jr. as HHS Secretary in February, all members of a panel trusted to guide U.S. vaccine policy were ousted and replaced with a committee now at odds with many major medical groups. Several CDC leaders have resigned or been fired. Use of the messenger RNA vaccines that helped end the COVID-19 pandemic has been narrowed. Broader changes to the childhood vaccine schedule have been discussed, too.
The speedy overhaul has occurred amid a backdrop of declining vaccination rates, and as U.S. measles cases have hit their highest levels since the disease was declared eliminated a quarter century ago. Caught in the middle are vaccine makers now trying to navigate a new era of regulatory uncertainty.
BioPharma Dive will continue tracking the changes to U.S. vaccine policy in the months ahead. But for now, we think it’s a good time to reflect on what’s happened already. Thanks as always for reading BioPharma Dive.
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Scientists say HHS’ decision to defund mRNA vaccine research will leave the country less prepared for pandemics, and make it harder to invest in companies advancing the technology.
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After a tumultuous two-day meeting marked by confusion and missteps, an advisory committee endorsed guidelines that would urge people to discuss vaccination's benefits and risks with their physician.
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The 17 advisers fired in June by Robert F. Kennedy Jr. urged alternatives to ACIP be organized to limit further degradation in vaccine guidelines.
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To maximize RWD’s potential, pharma companies should begin with their business or clinical goals.
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The action will remove from use the very few flu shots that contain the contested preservative, elevating unproven fears it poses health risks.
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UPDATED
The agency will now require randomized, controlled data before approving new COVID shots for healthy children and adults, Commissioner Martin Makary and top vaccine official Vinay Prasad wrote in NEJM.
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UPDATED
The committee reconvened Friday to re-do a vote on coverage of the combined MMRV shot through the Vaccines for Children program, citing panelists’ confusion the day before.
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Tailored Messaging Boosts Specialty Rx First-Fills
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