Federal vaccine advisers are reshaping how the United States will approach Covid shots in the coming seasons, shifting from blanket recommendations to a more individualized, risk based strategy. Their decisions will determine which formulas reach pharmacies, who is urged to get them, and how much weight safety concerns carry alongside protection against severe disease. The stakes are high for older adults, people with chronic conditions, and families trying to navigate conflicting political and scientific messages.
At the center of the debate is the Advisory Committee on Immunization Practices, or ACIP, which guides the Centers for Disease Control and Prevention on vaccine use. Its recent meetings have exposed deep tensions over how aggressively to promote Covid vaccination, how to weigh rare side effects, and how much authority to leave in the hands of patients and their clinicians.
The new mission for federal vaccine advisers
In the past year, the political environment around Covid vaccination has shifted, and so has the mandate given to key federal advisers. A panel of experts now advising Robert F. Kennedy Jr., who oversees health policy in the current administration, has been directed to focus heavily on potential harms from vaccines, with one leader saying that for this group, “Efficacy will be secondary.” That framing, described in detail in reporting on RFK, marks a sharp departure from the long standing emphasis on preventing hospitalizations and deaths as the primary goal of immunization policy.
That shift has rippled into the work of ACIP, which is formally an advisory committee to The CDC and does not itself approve products. As infection prevention specialists have pointed out, The CDC can only issue guidance after the Food and Drug Administration has cleared a vaccine, and ACIP’s role is to recommend how those products should be used, not whether they exist on the market at all. One expert warned that Neither ACIP nor the Advisory Co that supports it can substitute for FDA oversight, and that blurring those lines could have serious consequences for high risk populations, a concern laid out in detail in debate over the new direction.
Inside ACIP’s pivot to “shared decision-making”
ACIP’s most visible change has been its move away from a simple “everyone should get a Covid booster” message toward what it calls shared clinical decision making. In a closely watched vote, the committee endorsed a framework in which patients, especially those not at clearly increased risk, are expected to talk with their clinicians about individual benefits and downsides before getting another dose. The Key Takeaways from that meeting, summarized in a detailed account of how ACIP handled COVID recommendations, describe a 12 to 1 vote in favor of this approach for people at higher risk and a narrower margin for those at standard risk, reflecting the committee’s internal divisions as captured in Key Takeaways.
That philosophy was reinforced in a separate summary of ACIP COVID Vaccine Recommendations, which emphasized that Recommendations should spell out who is eligible, how clinicians should discuss risks and uncertainties, and what informed consent ought to include. The same account noted that in a tie vote, the committee declined to require prescriptions for Covid shots, a move that would have sharply limited access once the fall season officially begins on October 1, according to Recommendations from that meeting.
FDA’s strain strategy and the science behind the next shots
While ACIP wrestles with who should get vaccinated, the Food and Drug Administration has been focused on what the next generation of shots should look like. The FDA’s Vaccines and Related Biological Products Advisory Committee unanimously backed a monovalent JN.1 lineage composition for the 2025 to 2026 Covid vaccines, and Following the vote regulators signaled that manufacturers should pivot away from older, multi strain formulas. That decision, detailed in an FDA overview of the 2025 to 2026 Formula for use in the United States beginning in fall 2025, set the scientific baseline for the coming season and is described in depth in Following the committee’s deliberations.
Building on that, The FDA later issued Key Takeaways recommending that 2025 to 2026 Covid vaccines be monovalent and target the LP. 8.1 strain, aligning the composition with the variants most likely to circulate. Regulators warned that this LP. 8.1 recommendation could affect which products remain available and how quickly manufacturers can update their lines, a point spelled out in guidance on how The FDA expects COVID shots to evolve, as detailed in Key Takeaways on the strain choice.
CDC guidance: from universal boosters to tailored advice
Once FDA decisions are in place, CDC clinicians translate them into practical guidance for doctors and the public. In its 2025 to 2026 COVID Vaccination Guidance, the agency states that the 2025 to 2026 Covid vaccine is recommended for people ages 6 months and older, but again, based on individual based decision making that weighs personal risk factors. The same “At a glance” summary underscores that clinicians should consider age, underlying conditions, and prior infection when advising patients, a framework laid out in detail in the CDC’s routine guidance on COVID vaccination.
Separate consumer facing guidance on staying up to date reiterates that What people need depends on age and health status, but CDC still recommends a 2025 to 2026 COVID vaccine for everyone 6 months and older, including people with long Covid. That advice, which appears on the agency’s stay up to date page, reflects a balancing act between ACIP’s shared decision making language and the need for clear public messaging, as outlined in the CDC’s overview of how to remain current on COVID shots.
Safety skeptics at the table and the Malone factor
The composition of ACIP itself has become a flashpoint, particularly with the presence of figures who have questioned mainstream vaccine science. One of the most prominent is Dr. Robert Malone, who has been photographed at an Advisory Committee on Immunization Practices meeting in Atlanta, where he raised concerns about mRNA platforms and alleged inflammatory reactions. His participation, documented in a detailed account of that gathering that credits photographer Alyssa Pointer, has fueled criticism that the panel is giving disproportionate weight to fringe views, as described in coverage of Robert Malone and his role.
Those concerns intersect with the broader mandate given to Kennedy’s advisers, who, as noted earlier, have been told that Efficacy will be secondary to investigating side effects. A detailed political profile of Robert Kennedy Jr’s health team describes how this focus has emboldened vaccine skeptics and shifted the tone of federal discussions, including at ACIP, where some members now feel pressure to highlight rare adverse events even when the overall risk benefit balance remains strongly in favor of vaccination, as outlined in reporting on Robert and his advisers.
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*This article was researched with the help of AI, with human editors creating the final content.
