According to internal memos made public following a lawsuit against the US Department of Health and Human Services (HHS), there was little data to end the Covid vaccine recommendation for pregnant people and children.
The memos overlooked hundreds of studies on the benefits and safety of the Covid vaccine and set the precedent for making changes to vaccine recommendations based on ideology rather than evidence, critics say.
As officials make dramatic changes to immunization recommendations in the US, members of the Advisory Committee on Immunization Practices (ACIP), several of whom have expressed anti-vaccine views, signaled that they are embracing vaccinations during pregnancy. The committee, which is scheduled to meet on Wednesday and Thursday, reportedly recently thwarted plans to end recommendations for all Covid vaccines that use messenger RNA (mRNA).
On May 27, Robert F. Kennedy Jr, HHS secretary and long-time vaccine opponent, made a unilateral change to Covid vaccine recommendations via a post on
Two internal memos on vaccination during pregnancy and childhood, both dated May 12, circulated in US health agencies before the decision and have now come to light in the context of the lawsuit filed by the American Academy of Pediatrics (AAP) against the administration.
“Those memos blew me away,” said Kevin Ault, an obstetrician and gynecologist who served as an expert on ACIP working groups until outside representatives were excluded. Officials “omitted 99% of the data on the subject” they analyzed, he said. Gathering its own evidence base and making decisions through internal memos is “very unusual,” he added.
Naima Joseph, a maternal-fetal medicine specialist at Boston Medical Center who was part of the ACIP task force for the Covid vaccine, said: “The appointments were not based on evidence, but rather biased perspectives.” Removing the recommendations “is not in line with international recommendations, such as those of the WHO,” he added, and the move left the United States out of step with other nations.
Tracy Beth Høeg, who at the time was senior advisor for clinical sciences to Marty Makary, commissioner of the US Food and Drug Administration (FDA), wrote a short memo with just 12 citations, including two from her own studies, about Covid vaccines during pregnancy. He noted that the initial randomized clinical trials of “Pfizer, Modern (sic) and Novavax excluded pregnant women,” but failed to note that some people became pregnant during the trials and showed no adverse side effects, and since then at least 258 studies have demonstrated the safety and effectiveness of the Covid vaccine during pregnancy.
The evidence on Covid vaccination was “misinterpreted” and “distorted”, Joseph claimed. Data from the U.S. Centers for Disease Control and Prevention (CDC) does not show an increased risk of short- or long-term complications from vaccination, he said: “The data is very reassuring and at this point, it’s really a very well-studied vaccine in pregnancy.”
On the contrary, the risk of Covid infection remains a major concern. Covid infects the placenta, which can lead to poor intrauterine growth, prematurity, stillbirth and other complications. Compared to unvaccinated people, people who receive the Covid vaccine during pregnancy have a lower risk of complications, keeping recipients out of the hospital and intensive care unit and preventing premature birth.
Even after years of acquired immunity from infection, “we still see data supporting that vaccination helps,” Joseph said. Ending the recommendation “puts pregnant women and their babies at greater risk for preventable complications,” she said.
Vaccination during pregnancy has benefits that extend far beyond birth. Babies under six months cannot be vaccinated against Covid and have one of the highest rates of hospitalization for the virus. Vaccination during pregnancy can help protect against serious diseases. There is also some evidence that forgoing vaccines during pregnancy can lead to delays or omissions in babies’ vaccinations. “This gets the whole process off to a bad start: If there is confusion about maternal vaccines, that can spill over into the newborn’s first or second year of vaccination,” Ault said.
In May, officials also targeted Covid vaccines for children. A memo from Matt Memoli, principal deputy director of the National Institutes of Health (NIH), and Sara Brenner, principal deputy commissioner of the FDA, said there was “no clear evidence” that the benefits of the Covid vaccine “outweigh the risk of harm in children under 18 years of age,” but cited at least one study that concluded that Covid deaths in children had decreased significantly in part because of vaccination. Other studies, not mentioned by officials, show that vaccination against Covid in childhood helps reduce long-term symptoms, complications such as myocarditis and hospitalization.
As of press time, HHS did not respond to questions about the claims made in the memos and the role they played in restricting vaccines.
ACIP members said they had created a task force for vaccination during pregnancy in December. Previously, each task force included obstetricians and gynecologists as outside experts, but they were excluded from discussions during the Kennedy administration. After being excluded, the AAP left the meetings and the American College of Obstetricians and Gynecologists (ACOG) recently announced that it would no longer participate either.
