There was scant data behind ending the Covid vaccine recommendation for pregnant people and children, according to internal memos made public because of a lawsuit against the US Department of Health and Human Services (HHS).
The memos overlooked hundreds of studies on the benefits and safety of Covid vaccination and set the precedent for making changes to vaccine recommendations based on ideology instead of evidence, critics say.
As officials make dramatic changes to immunization recommendations in the US, members of Advisory Committee on Immunization Practices (ACIP), several of whom have expressed anti-vaccine views, signaled they are taking up vaccines in pregnancy. The committee, which is scheduled to meet on Wednesday and Thursday, reportedly scuttled plans recently to end recommendations for all Covid vaccines using messenger RNA (mRNA).
On 27 May, Robert F Kennedy Jr, the health secretary and a longtime vaccine opponent, made a unilateral change to Covid vaccine recommendations via a post on X – the first in a series of changes US health leaders have made to reshape recommendations dramatically for routine immunizations in the US. The vaccines would no longer be recommended for “healthy” children and pregnant people in the US, he said.
Two internal memos on vaccination during pregnancy and childhood, both dated 12 May, circulated at US health agencies before the decision, and they have now come to light as part of the lawsuit brought by the American Academy of Pediatrics against the administration.
“I was blown away by those memos,” said Kevin Ault, an obstetrician and gynecologist who served as an expert for ACIP working groups until outside representatives were excluded. Officials “missed 99% of the data on the topic” they analyzed, he said. Putting together their own evidence base and making decisions via internal memos is “highly unusual”, he added.
Naima Joseph, a maternal fetal medicine specialist at Boston Medical Center who served on the ACIP working group for the Covid vaccine, said: “The citations were not evidence-based, but more like biased perspectives.” Taking away the recommendations is “not aligned with international recommendations, such as the WHO”, she added, and the move put the US out of step with other nations.
Tracy Beth Høeg, who was at the time the senior adviser for clinical sciences to Marty Makary, the commissioner of the US Food and Drug Administration, wrote a short memo with only 12 citations, including two of her own studies, on Covid vaccines in pregnancy. She pointed out that the initial randomized clinical trials from “Pfizer, Modern [sic] and Novavax excluded pregnant women”, but did not note that some people became pregnant during the trials and showed no adverse side effects – and at least 258 studies have since shown the safety and effectiveness of Covid vaccination in pregnancy.
The evidence on Covid vaccination was “misconstrued” and “distorted”, Joseph said. Data from the US Centers for Disease Control and Prevention (CDC) shows no increased risk of short- or long-term complications from vaccination, she said: “The data are so reassuring, and it’s really, at this point, a very well-studied vaccine in pregnancy.”
The risk of Covid infection, conversely, remains a big concern. Covid infects the placenta, which can lead to poor intrauterine growth, prematurity, stillbirth and other complications. Compared with unvaccinated individuals, people who receive Covid vaccines in pregnancy have a lower risk of complications, keeping recipients out of the hospital and the intensive care unit and preventing pre-term delivery.
Even after years of immunity acquired by infection, “we’re still seeing data to support that vaccination helps,” Joseph said. Ending the recommendation “puts pregnant women and their infants at higher risk for complications that are preventable”, she said.
There are benefits to vaccination in pregnancy that extend far beyond birth. Babies under the age of six months cannot get vaccinated against Covid, and they have one of the highest rates of hospitalization for the virus. Vaccination in pregnancy can help protect them against serious illness. There is also some evidence that forgoing vaccines in pregnancy may lead to delayed or skipped vaccination for babies. “It gets the whole process off to a poor start – if there’s confusion about maternal vaccines, that can bleed over into the first year or two of vaccines for the newborn,” Ault said.
Officials in May also took aim at Covid vaccines for children. A memo from Matt Memoli, principal deputy director at the National Institutes of Health, and Sara Brenner, principal deputy commissioner of the FDA, said that there was “no clear evidence” that the benefits of Covid vaccination “outweigh the risk of harm in children under 18 years of age” – but they cited at least one study that concluded Covid deaths in children had fallen significantly in part because of vaccination. Other studies, not mentioned by the officials, show Covid vaccination in childhood helps reduce long-term symptoms, complications such as myocarditis and hospitalization.
The HHS did not respond by press time to questions about claims made in the memos and the role they played in restricting vaccines.
Members of ACIP said they had created a working group for vaccination in pregnancy in December. Previously, every working group already included obstetricians and gynecologists as outside experts, but they were excluded from the discussions under Kennedy. After being excluded, the American Academy of Pediatrics left the meetings, and the American College of Obstetricians and Gynecologists recently announced it would no longer participate as well.