On June 9, 2025, the United States (U.S.) Department of Health and Human Services (HHS) removed the 17 sitting members of the Centers for Disease Control and Prevention’s (CDC's) Advisory Committee for Immunization Practices (ACIP). This is a federal advisory committee that provides recommendations on the use of vaccines for the U.S. population. ACIP recommendations adopted by the CDC Director are included on the CDC immunization schedules and generally are required to be covered by applicable health plans. The HHS announcement noted that the Biden administration had appointed all of these ACIP members, with 13 being appointed in 2024. As a result, the current administration would not have been able to choose a majority of the committee until 2028. The HHS Secretary has stated these changes are intended to reestablish public confidence in vaccine science. On June 25 to 26, 2025 an ACIP meeting convened with seven new voting members. The advisory committee recommended Merck’s clesrovimab-cfor (Enflonsia) for prevention of respiratory syncytial virus (RSV) for infants who are not protected by a maternal vaccine, and voted to update the Vaccines for Children program to include Enflonsia. Additionally, ACIP reaffirmed routine annual influenza vaccination for all persons aged ≥ 6 months of age, who do not have contraindications, for the upcoming influenza season, and voted to recommend that children ≤ 18 years of age, pregnant women and all adults receive seasonal influenza vaccines only in single dose formulations that do not contain thimerosal as a preservative. The American Academy of Pediatrics (AAP) has stated the ACIP vaccination review is no longer a credible process; therefore, AAP will continue to publish their own immunization schedule as the organization has always done.  

In related news, the HHS announced on May 27, 2025 that the COVID-19 vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule. Following this announcement, the American College of Obstetricians and Gynecologists (ACOG) released a statement supporting the safety and efficacy of COVID-19 vaccination during pregnancy and the protection it provides to pregnant patients and their infants after birth. Furthermore, the CDC published the updated child and adolescent immunization schedule by age and recommends shared clinical decision-making for COVID-19 vaccination for individuals ages 6 months to 17 years who are not moderately or severely immunocompromised.

The U.S. Food and Drug Administration (FDA) has announced the Commissioner’s National Priority Voucher (CNPV) pilot program that intends to shorten the FDA review time for approval of drugs from 10 to 12 months to one to two months after final drug application submission. In the first year of the program, the FDA intends to give a limited number of vouchers to manufacturers who are aligned with U.S. priorities which include (1) addressing a national health crisis, (2) delivering innovative cures, (3) addressing unmet public health needs and (4) enhancing domestic drug manufacturing. A specific investigational new drug can receive a voucher, or vouchers can be granted to a company as “undesignated” which allows the company to use the voucher for a new drug at the company’s discretion in alignment with the program’s objectives. To qualify, drug developers must submit the chemistry, manufacturing and controls (CMC) portion of the application as well as the draft labeling at least 60 days prior to submission of the final application. Vouchers issued can then be redeemed by drug developers resulting in participation in the priority program that includes a team-based, one-day “tumor board style” review meeting. Prior to the team-based meeting, a multidisciplinary team of physicians and scientists will pre-review the submitted clinical information. The CNPV program will also include ongoing communication with the drug sponsor throughout the process, and it is expected that sponsors be available for prompt responses to FDA inquiries during the review. The FDA has authority to extend the review timeframe if application data are incomplete, results from clinical studies are ambiguous or in the event of a complex review.