Flu Vaccines Should Not Be This Hard - The Atlantic

Listen−1.0x+<br>Seek<br>0:0010:01

In a typical year, the process of bringing a new seasonal flu shot to market is one of the United States’ most predictable vaccine routines. This, however, is not a typical year.

Vaccine manufacturers have prepared updated versions of the annual flu shot, as they normally do. The FDA has green-lighted those recipes, as it normally does. And normally, the next step would fall to the CDC’s expert vaccine advisory panel, known as ACIP, which guides the agency’s recommendations for which Americans should take those shots. The CDC almost always accepts ACIP’s advice verbatim—and those recommendations inform health-care providers’ advice to their patients and coverage from private insurance and government programs.

But in March, a ruling from a federal judge effectively suspended ACIP, on the grounds that Health Secretary Robert F. Kennedy Jr. had violated the lawful procedure for selecting new members when he hastily remade the panel’s roster last June. Currently, no functional ACIP exists to guide this autumn’s immunization campaigns. (The Trump administration has appealed the judge’s order.)

Although ACIP itself doesn’t make policy, the CDC has depended on its guidance on vaccination for more than 60 years—and has almost never strayed from its advice. Without the committee, the federal government is missing a crucial check on how vaccines might best protect Americans. The experts I spoke with—nearly a dozen former ACIP members, former HHS officials, pediatricians, and vaccine lawyers—told me that they have never encountered such a profound level of ambiguity and uncertainty about this basic government pursuit. “Even those of us who follow this 24/7 don’t completely understand where anything stands right now,” Michelle Fiscus, a pediatrician and the chief medical officer of the Association of Immunization Managers, told me.

In the past two months, Kennedy has made multiple attempts to issue a new ACIP charter—a key step toward reconstituting the panel. At the end of last month, President Trump also signed an executive order that called on the CDC and ACIP to review and reaffirm the pared-down vaccination schedule—including more limited recommendations for flu and COVID vaccines—that the administration has previously put together (and that the judge’s order has voided for now). Both actions suggest that the administration might attempt to cobble together a new vaccine advisory committee in the coming weeks or months, which could address the new flu and COVID vaccines, Dorit Reiss, a vaccine-law expert at UC Law San Francisco, told me. Alternatively, Reiss said, Jay Bhattacharya, the acting CDC director, could issue a set of recommendations, leapfrogging the ACIP step. Depending on how the administration approaches these options, though, it could open itself up to further legal challenge.

The experts I spoke with for this piece were all tentatively optimistic that—even if ACIP remains in disarray—Americans will still be able to get their flu vaccines this fall. They were less certain about COVID vaccines, which since 2023 have been annually updated through a similar, if less well-established, process and are now similarly jammed up. New formulations for both vaccines now have the FDA’s nod, clearing the path for manufacturers to crank out doses and sell them, and for health-care providers to receive and deliver them. ACIP was suspended in March, but generally, by that point in the year, states and health-care providers have put in most of their preorders for fall flu shots, experts told me. A spokesperson for Sanofi, which is one of the main manufacturers of U.S. flu vaccines and also handles sales of the Novavax COVID vaccine, confirmed in an email that preorders for both of those shots have already been placed. Strain selection—part of FDA approval—“is the critical step to ensure timely manufacturing, not ACIP,” the spokesperson wrote.

Many experts also suspect that private insurance will cover this autumn’s slate of shots, pointing to a recent statement from AHIP, a trade association representing health-insurance companies, that reaffirmed its commitment to an “evidence-based approach to coverage of immunizations”; in an email, a spokesperson wrote that those sources of evidence may go beyond ACIP recommendations. (Insurers could, for instance, follow the recommendations from professional societies, such as the American Academy of Pediatrics—a plaintiff in the lawsuit that nullified recent ACIP decisions—which have published vaccine schedules that mostly mirror earlier CDC guidance.) Separately, multiple states have pledged to maintain broad insurance coverage for vaccines.

Whether the federal Vaccines for Children Program, or VFC, can offer the shots, though, is a gray area. ACIP is the sole arbiter of which vaccines are included in the program, which provides vaccines to children whose families might not otherwise be...