US Covid Vaccine Recommendations Criticized for Lack of Evidence
Internal memos obtained through a lawsuit against the US Department of Health and Human Services (HHS) reveal that scant data supported the decision to end Covid vaccine recommendations for children and pregnant individuals. Critics argue that hundreds of studies on vaccine benefits and safety were overlooked, setting a precedent for policy changes driven by ideology rather than evidence.
As the US Advisory Committee on Immunization Practices (ACIP) prepares to meet, members—some with previously expressed anti-vaccine views—are reportedly considering ending recommendations for all messenger RNA (mRNA) Covid vaccines, including those for pregnancy. The committee's meeting is scheduled for Wednesday and Thursday.
Unilateral Changes by HHS Secretary Robert F. Kennedy Jr.
On 27 May, HHS Secretary Robert F. Kennedy Jr., a longtime vaccine critic, announced via a post on X a unilateral change to Covid vaccine recommendations. He stated that vaccines would no longer be recommended for "healthy" children and pregnant people in the US. This announcement marked the first in a series of significant shifts in routine immunization guidance by US health authorities.
Two internal memos dated 12 May, addressing vaccination during pregnancy and childhood, circulated within US health agencies prior to this decision. These documents have surfaced as part of a lawsuit filed by the American Academy of Pediatrics (AAP) against the administration.
Experts Condemn the Memos for Ignoring Evidence
Kevin Ault, an obstetrician and gynecologist and former ACIP working group expert, expressed shock at the memos' content.
"I was blown away by those memos," he said. "Officials missed 99% of the data on the topic they analyzed." He described the practice of compiling an evidence base and making decisions solely through internal memos as "highly unusual."
Naima Joseph, a maternal-fetal medicine specialist at Boston Medical Center and former ACIP Covid vaccine working group member, criticized the memos' citations as lacking evidence-based rigor.
"The citations were not evidence-based, but more like biased perspectives," she stated. She added that removing vaccine recommendations contradicts international guidance, such as that from the World Health Organization (WHO), and places the US out of alignment with other countries.
Limited and Selective Evidence in Official Memos
Tracy Beth Høeg, then senior adviser for clinical sciences to FDA Commissioner Marty Makary, authored one of the memos on Covid vaccines in pregnancy. Her memo contained only 12 citations, including two of her own studies. It noted that initial randomized clinical trials from Pfizer, Moderna, and Novavax excluded pregnant women but did not mention that some participants became pregnant during the trials without adverse effects. Additionally, numerous subsequent studies have demonstrated the safety and efficacy of Covid vaccination during pregnancy.
Joseph stated that the evidence on Covid vaccination had been "misconstrued" and "distorted." She cited data from the US Centers for Disease Control and Prevention (CDC) showing no increased risk of short- or long-term complications from vaccination.
"The data are so reassuring, and it’s really, at this point, a very well-studied vaccine in pregnancy," she said.
Risks of Covid Infection in Pregnancy and Benefits of Vaccination
Conversely, Covid infection during pregnancy remains a significant concern. The virus can infect the placenta, potentially causing poor intrauterine growth, prematurity, stillbirth, and other complications. Vaccinated pregnant individuals experience fewer complications compared to unvaccinated peers, with reduced hospital and intensive care admissions and lower rates of pre-term delivery.
Joseph emphasized ongoing benefits of vaccination despite widespread immunity from infection.
"Even after years of immunity acquired by infection, we’re still seeing data to support that vaccination helps," she said. "Ending the recommendation puts pregnant women and their infants at higher risk for complications that are preventable."
Vaccination during pregnancy also protects infants under six months old, who cannot be vaccinated and face high hospitalization rates from Covid. There is evidence suggesting that skipping maternal vaccination may lead to delayed or missed vaccinations for babies, potentially disrupting early childhood immunization schedules.
"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 explained.
Concerns Over Covid Vaccines for Children
In May, officials also questioned Covid vaccines for children. A memo from Matt Memoli, principal deputy director at the National Institutes of Health (NIH), and Sara Brenner, principal deputy commissioner of the FDA, asserted there was "no clear evidence" that vaccination benefits outweighed risks for those under 18. However, they cited at least one study indicating Covid deaths in children had declined partly due to vaccination. Other studies, omitted from the memos, demonstrate that childhood vaccination reduces infection rates and complications such as multisystem inflammatory syndrome in children (MIS-C).
The HHS had not responded by press time to inquiries regarding the memos' claims and their influence on vaccine policy restrictions.
Exclusion of Experts and Organizational Withdrawals from ACIP
ACIP members reported forming a working group on vaccination during pregnancy in December. Previously, obstetricians and gynecologists participated as outside experts in all working groups, but under Kennedy's leadership, they were excluded from discussions. Following their exclusion, the AAP ceased attending meetings, and the American College of Obstetricians and Gynecologists (ACOG) recently announced it would also no longer participate.
