American Pharmacists Association Withholds Endorsement Of CDC's Revised COVID-19 Vaccine Guidance
The American Pharmacists Association announced Monday it will withhold endorsement of the Centers for Disease Control and Prevention’s updated immunization schedule that removed COVID-19 vaccine recommendations for pregnant women and healthy children.
What Happened: The CDC modified its guidance last month, stating COVID-19 vaccines remain optional for healthy children when parents and physicians determine necessity, reported Reuters. Health Secretary Robert F. Kennedy Jr., who oversees the CDC, Food and Drug Administration and National Institutes of Health, announced the policy changes before official website updates.
“COVID-19 vaccination during pregnancy has been proven safe and effective. Additionally, this vaccine is not associated with any fertility issues in either women or men,” the pharmacists’ association stated. The group emphasized that pregnancy represents a high-risk condition requiring COVID-19 vaccination recommendations.
Kennedy’s announcement bypassed the traditional CDC Advisory Committee for Immunization Practices review processes. The policy shift follows FDA changes limiting annual boosters to Americans over 65 and high-risk populations while requiring new clinical trials for healthy adults under 65.
Why It Matters: The FDA recently advised vaccine manufacturers that fall 2025 formulations should target monovalent JN.1-lineage variants, preferentially using the LP.8.1 strain. Moderna Inc. (NASDAQ:MRNA) submitted its Spikevax 2025-2026 formula application targeting the LP.8.1 variant Friday.
Novavax Inc. (NASDAQ:NVAX) received limited FDA approval for its Nuvaxovid vaccine, authorized for individuals 65 and older and those 12 and up with underlying medical conditions. The approval triggered a $175 million milestone payment from partner Sanofi SA (NASDAQ:SNY).
The policy changes create uncertainty for vaccine manufacturers and healthcare investors as the administration implements stricter clinical trial requirements. Previous guidance under the Biden administration recommended additional COVID-19 boosters for healthy children despite limited clinical data supporting repeat booster strategies in pediatric populations.
Read Next:
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
Photo courtesy: JHVEPhoto / Shutterstock.com