Internal memos from the U.S. Department of Health and Human Services (HHS), made public through a lawsuit, detail the information used to support a change in COVID-19 vaccine recommendations for children and pregnant people. The policy shift has drawn criticism from some medical professionals and organizations who contend the decision was based on a limited selection of data.
The documents preceded a May 27 announcement by HHS Secretary Robert F. Kennedy Jr., who stated on the social media platform X that the vaccines would no longer be recommended for “healthy” children and pregnant individuals. The memos, both dated May 12, were released as part of a lawsuit filed against the administration by the American Academy of Pediatrics (AAP).
One memo, authored by Tracy Beth Høeg, then a senior adviser at the Food and Drug Administration (FDA), addressed vaccination during pregnancy and included 12 citations. A second memo, from National Institutes of Health (NIH) official Matt Memoli and FDA official Sara Brenner, addressed vaccination for children. It stated there was “no clear evidence” that the benefits of COVID-19 vaccination “outweigh the risk of harm in children under 18 years of age.”
Several medical experts who have reviewed the documents have publicly questioned the scope of the evidence cited.
Kevin Ault, an obstetrician and gynecologist who previously served as an expert for working groups of the Advisory Committee on Immunization Practices (ACIP), said officials “missed 99% of the data on the topic.” In a statement, he added that making decisions based on internal memos was “highly unusual.”
Dr. Naima Joseph, a maternal fetal medicine specialist who also served on an ACIP working group, stated that the memos’ citations were “not evidence-based, but more like biased perspectives.” Joseph said the change puts the U.S. out of alignment with international bodies such as the World Health Organization.
Critics of the policy change point to a broader body of research on the topic. They note that while initial clinical trials for vaccines from Pfizer, Moderna, and Novavax excluded pregnant participants, subsequent observational studies have examined the vaccine’s effects. Joseph stated that data from the Centers for Disease Control and Prevention (CDC) shows no increased risk of complications from vaccination and that the vaccine is “very well-studied in pregnancy.”
Those who support continued vaccination for these groups cite studies indicating that COVID-19 infection during pregnancy can affect the placenta and lead to complications. They also reference research showing that vaccination can reduce the risk of hospitalization and that antibodies passed to a fetus can help protect infants, who are not eligible for vaccination under six months of age.
In the memo concerning children, the authors cited at least one study that, according to critics, concluded that vaccination had contributed to a significant fall in COVID-19 deaths among children.
The HHS did not respond to a request for comment on the memos for the original report.
In related developments, the AAP and the American College of Obstetricians and Gynecologists (ACOG) announced they would no longer participate as outside experts in certain ACIP working group meetings after a change in committee procedures. An ACIP working group for vaccination in pregnancy was created in December.
