Vaccine Panel Risks Confusion on Pregnancy Covid Shot Move (1)

An independent panel that advises the CDC on immunization policy quietly expanded access to the Covid-19 vaccine to pregnant women, potentially spurring confusion for patients and doctors after US Health Secretary Robert F. Kennedy Jr. recommended they don’t need the shot.

The Centers for Disease Control this week updated the immunization schedule to recommend the Covid-19 vaccine during pregnancy through shared clinical decision-making. The guidance is notable since the CDC’s Advisory Committee on Immunization Practices didn’t specifically vote on whether to recommend the Covid-19 vaccine to pregnant women with its decision in September that adults should confer with medical professionals before getting the shot.

The updated recommendation shifts away from Kennedy’s move earlier this year to pull the Covid-19 vaccine from the immunization list for healthy pregnant women, adding uncertainty for patients and doctors on what the committee recommends versus what the health secretary says.

“This flip-flop on the recommendation around Covid vaccines and pregnancy adds confusion and makes it much more difficult for doctors to talk to their patients about this,” said Fiona Havers, the former head of the CDC’s respiratory virus hospitalization network team who left the agency after Kennedy’s shakeup of ACIP.

“I think the whole way that this administration has taken over the advisory committee and undermined the previous transparent, systematic, evidence-based process that was in place is problematic,” Havers said. “The consequences of this are very clear with all of the confusion.”

This action also continues to “underscore how unpredictable HHS and CDC policymaking has become under the current leadership,” Richard Hughes IV, a member of Epstein Becker & Green PC and a former executive with Moderna Inc., said in an email.

The US Department of Health and Human Services didn’t immediately respond to a request for comment about the recommendation, nor did ACIP Chair Martin Kulldorff.

‘Shared Clinical Decision-Making’

While this recommendation now makes it easier for pregnant women to get the Covid-19 vaccine, the idea that the shot is recommended based on shared clinical decision-making is “a little bit of a contradiction in terms,” said Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.

“Is it recommended, meaning you should get it? Or are you saying you can consider getting it with shared clinical decision-making?” Offit said in an interview. “Shared clinical decision-making means you can perfectly reasonably choose not to get it, whereas the recommendation means you should be getting this because you and your unborn child are at higher risk.”

Recommending that patients speak with a medical professional before getting the shot also isn’t helpful for clinicians because “it doesn’t actually give any recommendations about who should be receiving the vaccines,” Havers said.

“Every vaccine is shared clinical decision-making by default—you have to give informed consent to get a vaccine,” she said. “But one of CDC’s major roles is to help guide clinicians and tell them who should be vaccinated.”

The American College of Obstetricians and Gynecologists, which recommends the Covid-19 vaccine during pregnancy, said in an email that “inconsistencies and mixed messages from the CDC continue to introduce confusion into patients’ decision-making.”

“The science demonstrating the safety and efficacy of the COVID vaccine—including during pregnancy—has not changed,” a spokesperson for the group said. “Because of the full body of evidence, ACOG continues to recommend COVID vaccination during pregnancy.”

Kennedy’s decision earlier this year to pull the Covid-19 vaccine off the immunization schedule for healthy pregnant women also spurred concerns on whether vaccine access would be curtailed if health plans drop coverage.

The immunization schedule is tied to what various private insurers and Medicaid expansion programs are required to cover with no cost-sharing.

America’s Health Insurance Plans, the country’s biggest health insurance association, pointed Thursday to its statement shared in September that said its member plans will continue to cover all ACIP-recommended immunizations with no cost-sharing for patients through the end of 2026.

That includes coverage for the updated Covid-19 and influenza vaccines.

“While health plans continue to operate in an environment shaped by federal and state laws, as well as program and customer requirements, the evidence-based approach to coverage of immunizations will remain consistent,” AHIP said in a statement.