COVID Vaccine Recommendations for Pregnancy & Children Based on Flawed Data, Memos Reveal
The recent shift in U.S. Covid-19 vaccine recommendations wasn’t based on a comprehensive review of available data, according to internal memos released as part of a lawsuit against the Department of Health and Human Services (HHS). The documents suggest officials may have overlooked the vast majority of studies examining the benefits and safety of vaccination, particularly for pregnant individuals and children, raising concerns about the influence of ideology over evidence-based policy.
The controversy centers around changes announced in May by HHS Secretary Robert F. Kennedy Jr., a long-time vaccine opponent, who declared Covid vaccines would no longer be recommended for “healthy” children and pregnant people in the U.S. Via a post on X (formerly Twitter). This decision followed the release of two internal memos, dated May 12th, concerning vaccination during pregnancy and childhood, which have now come to light through litigation brought by the American Academy of Pediatrics (AAP).
Evidence Base Questioned
Experts who reviewed the memos express alarm at the limited scope of the data considered. Kevin Ault, an obstetrician and gynecologist who previously served as an expert for the Advisory Committee on Immunization Practices (ACIP), stated he was “blown away” by the omissions. “Officials ‘missed 99% of the data on the topic’,” he said, characterizing the process of forming recommendations based on internal memos as “highly unusual.”
Naima Joseph, a maternal fetal medicine specialist at Boston Medical Center and former ACIP working group member, echoed these concerns, describing the cited sources as “not evidence-based, but more like biased perspectives.” She emphasized that the move to end recommendations diverges from international guidance, such as that provided by the World Health Organization (WHO).
The memos themselves appear to support these criticisms. One memo, authored by Tracy Beth Høeg, then a senior advisor to the FDA commissioner, relied on only 12 citations, including two of her own studies, when assessing Covid vaccines in pregnancy. While acknowledging that initial clinical trials excluded pregnant women, the memo failed to mention that some participants became pregnant during the trials without experiencing adverse effects. It overlooked the substantial body of subsequent research – at least 258 studies – demonstrating the safety and effectiveness of Covid vaccination during pregnancy.
Understanding the Risks and Benefits
Data from the U.S. Centers for Disease Control and Prevention (CDC) shows no increased risk of short- or long-term complications from Covid-19 vaccination during pregnancy. In fact, vaccination is associated with a lower risk of complications for both the pregnant person and the baby, including reduced rates of hospitalization, intensive care admission, and preterm delivery.
The risk of Covid-19 infection itself remains a significant concern, as the virus can infect the placenta, potentially leading to intrauterine growth restriction, prematurity, and stillbirth. Even after acquiring immunity through prior infection, vaccination continues to offer benefits, according to Joseph. Ending the recommendation, she argues, “puts pregnant women and their infants at higher risk for complications that are preventable.”
For infants under six months of age, who are too young to be vaccinated directly, maternal vaccination provides crucial protection, as they have one of the highest rates of hospitalization for the virus. There is also some evidence suggesting that foregoing vaccines during pregnancy may lead to delays or omissions in a baby’s routine immunization schedule.
Changes to Childhood Vaccination Guidance
Similar concerns have been raised regarding the changes to Covid-19 vaccine recommendations for children. A memo from Matt Memoli of the National Institutes of Health (NIH) and Sara Brenner of the FDA stated there was “no clear evidence” that the benefits of vaccination outweighed the risks for children under 18. However, critics point out that the memo cited a study that actually found Covid-19 deaths in children had decreased, in part, due to vaccination. Other studies, not mentioned in the memo, demonstrate that vaccination in childhood can help reduce long-term symptoms, complications like myocarditis, and hospitalization.
ACIP and the Future of Vaccine Recommendations
The HHS did not respond to requests for comment regarding the claims made in the memos and their role in shaping the revised vaccine recommendations. The situation is further complicated by recent changes to the composition of ACIP, with several members expressing anti-vaccine views. The committee is scheduled to meet on Wednesday and Thursday, and reportedly scuttled plans to end recommendations for all mRNA Covid vaccines.
Members of ACIP created a working group for vaccination in pregnancy in December, but outside experts, including obstetricians and gynecologists, were excluded from the discussions under Kennedy’s leadership. This led to the AAP leaving the meetings, and the American College of Obstetricians and Gynecologists (ACOG) recently announced its withdrawal from the committee as well.
The unfolding situation raises fundamental questions about the process of establishing vaccine recommendations in the U.S. And the role of scientific evidence in public health policy. Ongoing scrutiny of the data and a commitment to transparent, evidence-based decision-making will be crucial to restoring public trust and ensuring effective protection against Covid-19 and other preventable diseases. Individuals with questions about Covid-19 vaccination should consult with their healthcare provider and refer to official public health updates from organizations like the CDC and WHO.