COVID-19 Vaccine Overhaul, Rocket Grounded, ‘One Tough Hombre’ on MFN

The name of the biopharma game this season is vaccines—and RFK Jr. wasted no time returning from Memorial Day Weekend before making news on this front, removing the COVID-19 vaccine from the list of recommended immunizations for healthy kids and pregnant women on Tuesday. This follows a rash of recent moves, including a new risk-based strategy for the approval of new COVID vaccines focused on adults over 65 and high-risk individuals six months to 64 years of age and a request that Moderna and partners Pfizer and BioNTech update the myocarditis risk on their vaccines’ labels.

This increased vaccine scrutiny by the FDA and Department of Health and Human Services is having a significant impact on biopharma companies, several of whom have received stop-work orders on next-gen COVID vaccines. Meanwhile, Moderna last week pulled the biological license application for its combination COVID-19/flu vaccine, anticipating a request for additional data on flu shot efficacy from the FDA, as mRNA technology continues to be scrutinized after playing the hero during the pandemic. Also last week, the White House released its Make America Healthy Again (MAHA) report, which took aim at vaccines, along with pharma lobbying and GLP-1s.

Also on the policy front, a California judge issued an order Thursday that indefinitely stops HHS’ goal of reducing its divisions from 28 to 15 and firing upwards of 10,000 employees, among other reorganization and mass layoff plans. And speaking of government plays that could receive judicial pushback, we received a couple of new updates on the Most Favored Nation (MFN) front: first, President Donald Trump appointed his CMS chief Mehmet Oz as the leader of drug pricing negotiations, calling him “one tough hombre,” and second, HHS provided new guidance for streamlining the process for states to import drugs from Canada.

In the obesity realm, Eli Lilly is calling out the Centers for Medicare and Medicaid Services. In an open letter last week, Lilly voiced its displeasure with the agency for a final ruling that left its Zepbound and Novo Nordisk’s Wegovy out of Medicare Advantage and Part D coverage in 2026.

And in the R&D realm, we returned from the long weekend to sad news from Rocket Pharmaceuticals, as the company reported that its pivotal Danon disease trial is on hold after the death of a young patient. The death—extremely sad on a human level—is also a setback for the gene therapy space, which had been buoyed earlier this month by the success of a personalized CRISPR treatment received by baby KJ.

Finally, BioSpace looks ahead to ASCO#25 where Dan Samorodnitsky will be on the ground in Chicago.