A look at the new COVID vaccine guidelines and what happened at ACIP

Wondering whether you’re eligible to get a COVID vaccine this fall and whether your insurance will pay for it? You’re not alone. The typically orderly process of setting annual public health guidelines for vaccines has been anything but this year. Competing recommendations came from leading medical organizations, the federal government, and states individually and in collaboration. It put unusual focus on the Advisory Committee on Immunization Practices (ACIP)’s recommendations. ACIP is the vaccine advisory group to the U.S. Centers for Disease Control and Prevention (CDC).

Yale School of Public Health Associate Professor Dr. Jason L. Schwartz, PhD, an authority on U.S. vaccine policy, has been following events closely. He recently spoke to Colin Poitras about this year’s recommendations for the COVID shot as well as new developments regarding the measles-mumps-rubella-varicella (MMRV) and Hepatitis B vaccines for infants and children.

Dr. Jason Schwartz: At its September 19 meeting, ACIP recommended that COVID vaccines can be administered to anyone 6 months of age or older, after consultation with a physician or another health care provider (including, in some states, a pharmacist). In contrast, the U.S. Food and Drug Administration has approved this year’s COVID vaccine only for people over age 65 and those considered at high risk due to certain medical conditions.

While it is not unprecedented for CDC/ACIP to endorse the use of a vaccine outside the margins of its FDA approval—what’s referred to as “off-label use”—it is quite uncommon and, unlike the widespread off-label use of pharmaceuticals, typically reserved for small populations in very limited circumstances. Here, ACIP has opened the door to off-label use of the vaccine for tens of millions of Americans, essentially all healthy individuals between 6 months and 65 years of age.

Still, this “shared clinical decision-making” guideline is a step down from the ACIP’s far more common, “routine” recommendations for vaccines. It is used in situations where the committee wishes to highlight vaccination as an option for individuals (i.e., “may vaccinate”) without actively encouraging it (i.e., “should vaccinate”). Importantly, it is still formally considered an ACIP recommendation for COVID vaccination. That means that, if adopted, it will appear on CDC/ACIP immunization schedules, ensuring continued no-cost coverage of COVID vaccines for all children regardless of insurance status. Adults with private insurance, Medicare, or Medicaid will also be covered. Coverage of vaccines for uninsured adults remains an unfortunate gap in our health care system.

It is important to note that as of Sept. 25, ACIP’s recommendations were only that—recommendations. They are still pending adoption by the acting CDC director, at which point they would become official CDC guidelines. It is currently unclear when or whether the director will make that decision.

JS: There is wide variation in state laws and regulations regarding where vaccines can be administered, by whom, and in what circumstances. Policy updates are therefore required in some states. Several states made these policy changes—for example, allowing pharmacists to provide counseling and vaccines without a prescription—before the ACIP meeting, and others are considering policy changes now.

When that work is completed, it’s quite likely that in most states, virtually anyone wishing to get a COVID vaccine this year should be able to do so, in many of the same locations—including pharmacies—where COVID vaccines have been available previously, and at no cost to them. Unfortunately, confusion over this year’s vaccine guidelines has already led to some pregnant people, people under age 65, and others seeking the vaccine being told they need to see their doctor. Individuals seeking information regarding vaccine access and eligibility in their area should consult their health care provider, pharmacy, or state/local health department for more specific information.

JS: It depends. The current ACIP vote on COVID vaccination allows for broad use of the vaccine, but it doesn’t identify any priority groups for vaccination other than those 65 years or older. However, the other medical and public health organizations that released COVID vaccine recommendations this summer have indicated groups for whom COVID vaccines are especially important. Here in Connecticut, for example, COVID vaccination is specifically recommended for:

— previously unvaccinated children

— adults 65 years and older

— pregnant women

— individuals of any age who are immunocompromised or with underlying risk factors for severe COVID illness.

The Connecticut recommendations note that these groups should be vaccinated, while other groups—healthy, previously vaccinated children and adults under age 65—may be vaccinated if they desire. There’s significant alignment across the many (non-ACIP) COVID vaccine recommendations issued by medical and public health organizations this summer, largely echoing these same priority groups for vaccination. In all cases, the best source for information regarding personal vaccination recommendations and decisions is one’s health care provider.

JS: Not for the MMR vaccine itself, but for a related vaccine, and only a minor change was made.

Since 2005, a vaccine has been available that combines measles-mumps-rubella (MMR) and varicella (chickenpox) into a single vaccine known as MMRV. For many years, the ACIP had recommended that children under age 4 receive the first doses of the MMR and varicella vaccines separately due to evidence of a slight increase in the occurrence of a rare, short-term vaccine-related adverse event in children receiving the combined MMRV vaccine. Those prior recommendations gave parents of children in this age group the option to choose MMRV for this first dose if they preferred it, perhaps because it meant one fewer injection for their child. Only 15% of parents selected this combined MMRV option. In the September 2025 meeting, ACIP voted to eliminate the MMRV option for younger children and now recommends only separate MMR and varicella vaccines in this very specific situation.

No changes were made regarding recommendations for the MMR and varicella vaccines themselves, which have demonstrated extremely high levels of safety and effectiveness throughout their decades of use; and no changes were made in recommendations for children age 4 and older. High rates of MMR vaccine remain particularly important in light of the nearly 1,500 cases of measles in the U.S. this year, over 90% of which occurred in individuals without evidence of vaccination.

JS: There are no changes to Hepatitis B (HepB) recommendations at this time. For decades, the first dose has been recommended to be given to newborns in the hospital shortly after birth. This “birth dose,” and a larger universal HepB vaccination strategy, was first adopted in the U.S. in 1991. It has been credited with the near elimination in cases of HepB transmitted to newborns at birth and massive declines in chronic Hepatitis B and related illnesses (like cirrhosis and liver cancer) in the U.S. over the last few decades.

Although there is no new or credible evidence suggesting potential safety concerns with the birth dose, the ACIP was considering a recommendation to delay the first vaccine until the 1-month well-child visit. The topic was tabled without a vote last week, but it’s quite likely that the committee will revisit this vaccine at a future meeting.