CDC vaccine panel review indicates potential changes to COVID, HPV immunization policies

In the first meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) under new HHS Secretary Robert F. Kennedy Jr., experts looked poised to change policies around vaccines that defend against two of the world’s most high-profile viruses—COVID and HPV.

Following Tuesday's deliberations, the ACIP panel appeared on track to recommend reduced uses of both types of immunization in potential blows to companies such as Pfizer and Merck & Co. The ACIP will vote on both subjects at the next meeting, June 25 to 26.

For COVID shots, analysts from Leerink Partners and Citi believe that the advisers are ready to narrow their recommendations for who should receive booster doses.  

“It looks likely ACIP will shift to risk-based from universal booster vaccine recommendations,” Leerink wrote in a note to investors.

Meanwhile, Citi cited a poll of the ACIP working group showing that 76% of the members favored a risk-based approach and “could signal how the work group votes at the next meeting.”

During Tuesday’s discussion, a majority of ACIP members voiced their support for a risk-based recommendation. One policy option proposed (PDF) by the group is to endorse two annual booster shots for those 65 and older and others with underlying conditions.

“I’m very happy that we’re seriously considering a risk-based recommendation. I’m glad that we’re taking this as a reasonable possibility,” committee member Jamie Loehr, M.D., said during the meeting.

Regarding implications for the COVID vaccine market, Leerink added that a move away from a universal recommendation for COVID shots would pressure expected revenues of Pfizer, BioNTech and Moderna this year and the next.

Another company closely watching the ACIP discussions is Merck, with sales of its blockbuster HPV vaccine Gardasil at stake.

“We were surprised that ACIP is leaning toward modifying the U.S. HPV vaccine schedule to reduce the number of recommended doses, given they would be acting ahead of the FDA to make an ‘off-label recommendation,’” Leerink wrote, adding that such an action “could reduce U.S. Gardasil revenue by more than 50%.”

New Gardasil data will inform the June discussion, reminded Leerink.

As for the ACIP session overall, while Leerink wrote that it “observed no change in ACIP’s process, deliverables or discussion,” it added that it may take some time for budget, policy or ACIP member changes to impact vaccine policy.

“The CDC director can accept or reject ACIP recommendations and this critical step for any controversial recommendations will be important to monitor for RFK impact on policy,” Leerink wrote.