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CDC advisers vote that patients must consult a health care provider for Covid-19 vaccination, but no prescription required

By CNN

Published September 19, 2025 6:20 pm

CNN

By Brenda Goodman, Jamie Gumbrecht, CNN

(CNN) — Vaccine advisers to the US Centers for Disease Control and Prevention voted unanimously on Friday to shift away from a broad recommendation for Covid-19 vaccines to say that people who want one must consult with a health care provider, a process known as shared clinical decision-making.

However, the Advisory Committee on Immunization Practices was split on whether to recommend that a prescription for a Covid-19 vaccine should be required. That vote was 6-6; Dr. Martin Kulldorff, the chair of the committee, voted no, which broke the tie.

The committee now says people 65 and older should make the decision about whether to get a Covid-19 vaccine with a doctor or another health care provider. It should be the same for people ages 6 months to 64 years, the vaccine advisers voted, but with “an emphasis that the risk-benefit of vaccination is most favorable for individuals who are at an increased risk for severe COVID-19 disease and lowest for individuals who are not at an increased risk, according to the CDC list of COVID-19 risk factors.”

The recommendations are not final and could still change; they go to Acting CDC Director Jim O’Neill for signoff. O’Neill, a deputy of HHS Secretary Robert F. Kennedy Jr.’s, has led the agency since Dr. Susan Monarez was ousted abruptly last month.

Practically, shared clinical decision-making means two things, said Dr. Dorit Reiss, a professor of law at the University of California, San Francisco who specializes in vaccines and vaccine policy.

“It’s an opt-in instead of opt-out: the doctor should initiate, and not all do,” Reiss posted on social media. “It usually leads to less uptake, partly because nobody is sure what it requires.

“It will create substantial confusion, and it will decrease uptake because of the confusion,” Reiss also told CNN.

Other experts agreed that the move would make Covid vaccines harder to get.

Requiring clinical decision-making “assumes health care and insurance,” said Dr. Demetre Daskalakis, who recently resigned as head of the CDC’s National Center for Immunization and Respiratory Diseases.

“We do not have universal health care in this country, and we know millions of people are losing insurance,” he added.

Enhancing informed consent

In a separate vote, the committee recommended that the CDC amend its the Covid-19 vaccine information statements, which spell out the risks and benefits of a vaccination.

The advisers wanted additional language in the statements on “at least six new risks and uncertainties” discussed by the work group, many of which were based on preliminary, and refuted scientific findings.

Legal experts noted that changing the vaccine information statement was beyond ACIP’s purview, since it requires a different process through the CDC.

“ACIP does not have authority to change the vaccine information statement off the floor. There is a detailed process for that,” Reiss said in a social media post.

The advisers also voted to recommend that health care providers consider known risk factors for severe outcomes from Covid-19, “such as age, prior infections, immunosuppression, and certain comorbidities identified by the CDC,” as part of the informed consent. “Especially those outlined in the vaccine information statement.”

Dr. Retsef Levi, a professor of operations management at MIT who is chair of the Covid-19 work group, said the group had consulted with “the appropriate people” and felt that the recommendations on informed consent were something they could weigh in on.

Nothing forbids ACIP from making such a recommendation, he said after the meeting, and “I think if you read and interpreted the role of ACIP as broad recommendations on issues related to vaccination policies, that’s very much at the core of what we are supposed to be thinking about.”

The US Food and Drug Administration has already made significant changes to this season’s shots by limiting approval to adults 65 and older as well as younger people who are at higher risk of severe Covid-19. People who don’t fall into these categories may still be able to get a vaccine if a provider is willing to give it off-label.

But the vote by the CDC’s advisory committee carries additional implications for vaccine access since some states adhere closely to its recommendations. The result may be a patchwork of vaccine access from state to state, depending in part on on who is able to administer vaccines and what providers are willing to offer it.

In a statement, a US Department of Health and Human Services spokesperson said the vote on shared clinical decision-making “provides for immunization coverage through all payment mechanisms including entitlement programs such as Children’s Health Insurance Program, Medicaid, and Medicare, as well as insurance plans through the federal Health Insurance Marketplace.”

AHIP, formerly America’s Health Insurance Plans, said its members — which provide coverage to more than 200 million Americans — have said they will continue to cover all immunizations that ACIP had recommended as of September 1 at no cost to patients through the end of 2026. This includes the updated Covid-19 and influenza vaccines.

Vote on hepatitis B vaccine for newborns postponed

The CDC advisory committee’s Covid-19 votes followed a chaotic start to the meeting, where advisers got a redo of an earlier decision around combined measles, mumps, rubella and chickenpox vaccines and then delayed a closely watched vote on the hepatitis B vaccine for newborns.

The vaccine advisers voted 11-1 on Friday to postpone a scheduled vote on changes to recommendations around the hepatitis B shot. It was a surprise twist after a lengthy discussion Thursday, when the advisers considered a recommendation to wait to give newborns a dose of the hepatitis B vaccine until they are at least a month old. Currently, babies are given this shot at birth, usually before they leave the hospital.

On Friday morning, one ACIP member suggested that the committee consider recommending the vaccine even later, at 2 or 3 months. Committee member Dr. Robert Malone then moved to postpone the vote indefinitely over “ambiguity” around “safety, effectiveness and timing” of the shots. Only Kulldorff, an epidemiologist and biostatistician who led an ACIP workgroup on the vaccine, voted against tabling the hepatitis B vaccine vote.

However, the vaccine advisers had already made one move on hepatitis B: a vote to recommend that pregnant women be tested for the virus. ACIP does not typically play a role in determining testing, and hepatitis testing is already part of recommended routine care during pregnancy.

“The goal of the vote is to encourage providers and health systems to increase the rates of testing in pregnancy to assure that women with Hepatitis B and their newborns can be properly cared for to reduce transmission of the virus from the mother to the child,” an HHS spokesperson said in a statement after the vote.

Anti-vaccine activists have long questioned the need for the birth dose of the vaccine, since hepatitis B is mainly transmitted through dirty needles or sexual activity. In a June town hall, Kennedy said “it’s really a profit motive” to give it to newborns.

But data shows that the campaign to vaccinate babies against hepatitis B — which has been recommended since 1991 — has been a success. After it was implemented, hepatitis B infections in infants dropped from an average of 18,000 per year to around 20 reported cases per year now.

Children infected with hepatitis B nearly always develop long-term infections that can damage the liver, increasing the risk of liver scarring and cancer or the need for a transplant.

It’s not clear how the committee will proceed. Several non-voting ACIP liaisons spoke up during the meeting to ask for clarity on next steps and why the hepatitis B vaccine was being reconsidered now, despite a lack of new evidence.

New vote on MMRV shots for some children

The CDC’s vaccine advisers also cast new votes Friday on the combined measles, mumps, rubella and chickenpox vaccine in the Vaccines for Children program.

On Thursday, they voted to recommend against using the combined vaccine for young children but, in a second vote, laid out different standards for kids receiving vaccines through the Vaccines for Children program, which provides shots for low-income children.

The new vote Friday brought the Vaccines for Children program in line with the other recommendation. Nine of the members voted in favor, and three abstained.

Dr. Jason Goldman, president of the American College of Physicians and a non-voting ACIP liaison, said during the meeting Friday that he was concerned about the conflicting MMRV votes, which would have created different recommendations for people at different socioeconomic levels.

It suggests, Goldman said, that the Vaccines for Children vote “actually revealed the truth that you do not have the data or evidence to challenge the current standing and that there is … no associated harm.”

ACIP member Dr. Joseph Hibbeln, a psychiatrist, responded that the wording of the first Vaccines for Children vote “was indeed confusing and not precise,” and there was new clarity around the wording by Friday morning.

Still, several medical groups expressed concern about the MMRV changes.

“The Advisory Committee on Immunization Practice’s (ACIP) new process and recommendations leave parents confused about how best to protect their kids and unable to choose the combined MMRV vaccine for children under 4 years old,” Dr. Sandra Adamson Fryhofer, the American Medical Association’s ACIP liaison, said in a statement. “The AMA is concerned that this change not only reduces parental choice, but also reflects ACIP’s reliance on selective data in forming its guidance.”