CDC Drops Guidance for COVID Vaccines for Pregnancy

The US Centers for Disease Control and Prevention (CDC) has just updated its child and adolescent immunization schedule in a way that states that parents who want to vaccinate healthy children could do so, based on shared decision making with a clinician.

The agency also updated the adult immunization schedule to say there is “no guidance” on use in pregnancy.

The update for children and adolescents seems to contradict the May 27 announcement on COVID vaccines by Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. In a 58-sec video posted to X, Kennedy said the COVID vaccine was “being removed from the CDC-recommended immunization schedule” for healthy pregnant women and also for healthy children. US Food and Drug Administration Commissioner Marty Makary, MD, said on the video that “there’s no evidence healthy kids need it today,” while National Institutes of Health Director Jay Bhattacharya, MD, called the move “good science.”

As of press time, HHS had not issued a formal proposal or written policy to further detail the announcement, but the CDC had change its online immunization schedules.

The see-sawing of the policy announcements — without any public meetings or input — have left clinicians perplexed and fearful about availability of the COVID-19 vaccine for healthy pregnant women and healthy children in advance of what is typically a surge of infections during the summer and fall months in the US. 

Linda Eckert, MD, a professor of obstetrics and gynecology at the University of Washington in Seattle, said she was “horrified” when she heard the announcement. “I was just like, why did this happen?” she told Medscape Medical News.

COVID during pregnancy “is dangerous to my patients, and when my patients don’t do well, their pregnancies don’t do well,” Eckert said. The virus is also very dangerous to infants during the first 6 months of life, “and maternal antibody transfer is the way that those infants are protected,” said Eckert, a member of the American College of Obstetricians and Gynecologists (ACOG) immunization committee.

The announcement prompts questions, but not many answers, she said. “What are we going to do with our patients? How are we going to have these conversations now?” said Eckert.

“We’re all trying to read the tea leaves as to what [Kennedy] really means,” said Paul Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, Leaving clinicians, insurers, and patients to guess is “a wholly irresponsible way to do business,” Offit told Medscape. 

Offit said that Kennedy has made no secret of his intent to focus on chronic disease while reducing resources for infectious disease. The Secretary “has for 20 years been an anti-vaccine activist and science denialist,” said Offit. “He’s basically doing what he can to tear down the vaccine infrastructure in this country,” he said.

Alarms Sounded

Many professional organizations expressed alarm at Kennedy’s announcement. The HHS Secretary bypassed the traditional process for vaccine recommendations, which includes discussion of evidence for safety and effectiveness at open public meetings held by the CDC’s Advisory Committee on Immunization Practices (ACIP). ACIP then makes a recommendation, which the CDC director approves or disapproves.

“It is concerning that such a significant policy change was made unilaterally outside an open, evidence-based process with no regard for the negative impact this will have on millions of Americans,” said Tina Tan, MD, president of the Infectious Diseases Society of America, in a statement.

“By removing the recommendation, the decision could strip families of choice,” said Sean O’Leary, MD, chair of the American Academy of Pediatrics’ Committee on Infectious Diseases, in a statement. “Those who want to vaccinate may no longer be able to, as the implications for insurance coverage remain unclear,” he said. “It’s also unclear whether healthcare workers would be eligible to be vaccinated.”

O’Leary said that the evidence shows that pregnant women, infants, and young children are at higher risk of hospitalization from COVID and that the vaccine’s safety “has been widely demonstrated.”

“Despite the change in recommendations from HHS, the science has not changed,” said ACOG President Steven J. Fleischman, MD, in a statement. Most infants under the age of 6 months who are hospitalized for COVID are born to unvaccinated mothers, said Fleschman. Kennedy’s announcement may mean pregnant people are less likely to choose to vaccinate, he said. “We are very concerned about the potential deterioration of vaccine confidence in the future,” said Fleischman.

Jason M. Goldman, MD, president of the American College of Physicians, agreed. “The HHS announcement will likely further erode public confidence in the safety of these vaccines, despite the evidence demonstrating their benefits,” he said, in a statement. Goldman also said the policy change has “the potential to threaten insurance coverage for COVID vaccines and boosters, increasing the cost and placing them out-of-reach of individuals who do still want to be vaccinated.” 

Who Will Get the COVID Vaccine?

Uptake of the vaccine has been waning, even with insurance coverage. 

According to CDC’s COVID-19 Vaccination Dashboard, 14% of pregnant women had received the 2024-25 vaccine. As of late March, just under 13% of children 6 months-to-17 years had received the vaccine, the CDC reported at the ACIP’s last meeting in April.

Children under 6 months have the second highest COVID-related hospitalization rates, comparable to those of adults aged 64-75; only adults aged 75 or older have higher rates, the CDC has reported. A fifth of 1000 hospitalized infants with COVID-19 during a 2-year period were admitted to an intensive care unit; nine died while hospitalized. Vaccination of mothers has led to a decline in hospitalizations, however, said the agency. Even so, 96 children under age 4 and 56 aged 5-17 died from COVID from September 2023 to August 2024, said CDC officials at the last ACIP meeting.

COVID’s dangers during pregnancy have been documented in many studies. Researchers from George Washington University in Washington, DC, reported in a 2023 paper that pregnant women with COVID-19 experienced 7 times greater risk of dying during pregnancy or childbirth, 3 times greater risk of being admitted to the ICU, 23 times greater risk of developing pneumonia, and 5 times greater risk of thromboembolic disease.

Eckert said that, despite the dangers, fewer patients have been opting for vaccination over the last few years “because people view COVID as less of a threat.” She still talks to patients about protection. The new recommendation is going to make it more difficult to help patients stay safe, she said.

Meanwhile, as reported by Medscape, the FDA announced earlier in May that it would be calling for more studies of COVID vaccines in healthy Americans and that it would recommend against approval except for individuals with a long list of conditions that put them at risk for more severe disease. One of those conditions is pregnancy or recent pregnancy.

The COVID vaccine announcements are “at the least, confusing for patients,” Eckert said. 

Will Policy Be Challenged?

It is not clear whether anyone can or will challenge the HHS policy announcement.

Normally, not even a CDC director would circumvent the ACIP’s process, said Dorit Reiss, professor of law at UC Law San Francisco. Currently, there is no acting CDC director, she said, adding that it appears that Kennedy has stepped into the role, as he reportedly approved an ACIP recommendation on a chikungunya vaccine.

While Kennedy is not violating a statute or regulation with his COVID vaccine announcement, a court could find that the decision is “arbitrary and capricious” because it was offered without evidence or a rationale, said Reiss. “These decisions are generally written out with references and a lot of data. They didn’t do that,” Reiss told Medscape.

Eventually, someone might legally challenge the policy, but it could take a while, said Reiss. The policy “will have to hurt someone” for someone to make a case, she said.

Reiss and Offit pointed out that vaccines could be prescribed off-label for groups that are not covered by any of the HHS recommendations.

“Probably 70% of the drugs on our formulary are not necessarily approved for pediatrics,” said Offit. But off-label use comes with its own set of headaches, he said. Clinicians might have to seek prior authorization from insurers, for instance.

When asked whether the administration might just remove approvals altogether for COVID vaccines, Offit responded that with Kennedy in charge, “anything is possible.”

Offit reports no relevant financial relationships. Eckert disclosed that she is the author of “Enough,” a book that calls for greater cervical cancer screening.

Alicia Ault is a Saint Petersburg, Florida-based freelance journalist whose work has appeared in many health and science publications, including Smithsonian.com. You can find her on X @aliciaault and on Bluesky @aliciaault.bsky.social.