Pharmacy Policy Updates for October 2025

ACIP Shifts COVID-19 Vaccine Guidance to Shared Decision-Making

The CDC Advisory Committee on Immunization Practices (ACIP) has fundamentally altered its approach to COVID-19 vaccination, moving away from a universal recommendation.¹ The committee now advises, after a unanimous vote on September 19, 2025, that COVID-19 vaccines be administered based on shared clinical decision-making for all individuals aged 6 months and older.¹

This change places pharmacists and other health care providers at the center of individualized discussions with patients. The new guidance emphasizes a collaborative process during which providers should discuss a patient’s specific risk factors for severe COVID-19, the known benefits and potential risks of vaccination, and any remaining uncertainties to help them make an informed choice. The committee also affirmed the need for more consistent informed consent processes.¹

This pivot raised immediate concerns about vaccine access and insurance coverage. Historically, ACIP recommendations have driven insurer coverage policies, and this move to a non-universal recommendation could impact future access.² However, a contentious proposal that would have required a prescription to receive the vaccine was defeated, a move that pharmacist committee member Hillary Blackburn, PharmD, MBA, argued was critical to preventing significant access barriers.¹

Pharmacists should be prepared to address data reaffirming the COVID-19 vaccines’ effectiveness, along with patient questions about debated safety topics, such as myocarditis, noting that major regulatory bodies continue to affirm the vaccines’ safety profile.

REFERENCES

1. Meeting of the Advisory Committee on Immunization Practices (ACIP) — September 19, 2025, Day 2 of 2. YouTube. Accessed September 25, 2025. https://www.youtube.com/live/_9ChY9SpPlY

2. AHIP statement on vaccine coverage. America’s Health Insurance Plans. News release. September 16, 2025. Accessed September 19, 2025. https://www.ahip.org/news/press-releases/ahip-statement-on-vaccine-coverage

ACIP Recommends Against Combined MMRV Vaccine for Young Children

The CDC Advisory Committee on Immunization Practices (ACIP) has voted to restrict the use of the combined measles-mumps-rubella-varicella (MMRV) vaccine for children younger than 4 years old. The new recommendation advises that this age group should instead receive the components as 2 separate injections: the MMR vaccine and the varicella vaccine.¹

ACIP’s decision was based on safety data indicating an elevated risk of febrile seizures in children aged 12 to 23 months occurring 7 to 10 days after receiving their first dose of the combined MMRV shot. This increased risk was not observed in children receiving separate MMR and varicella vaccines, nor was it seen after the second MMRV dose administered to children between the ages of 4 and 6 years.¹

In other business during ACIP’s meeting on September 18 and 19, 2025, the committee tabled a vote on changing the pediatric hepatitis B (HBV) vaccine schedule. The proposed change would have delayed the first dose for newborns of HBV-negative mothers until 1 month of age, a move partly intended to address public vaccine hesitancy. However, the vote was postponed for further refinement. For now, the HBV schedule remains unchanged.

Pharmacists will play a critical role in communicating the new MMRV guidance to caregivers and implementing the change in practice.

REFERENCE

Meeting of the Advisory Committee on Immunization Practices (ACIP) – September 18, 2025 – Day 1 of 2. Streamed on YouTube on September 18, 2025. Accessed on September 18, 2025. Accessible: https://www.youtube.com/live/-6uBNXsYRHQ

FDA Flags Acetaminophen Use in Pregnancy Despite No Causal Link to Autism

The FDA has announced it is initiating a label change process for acetaminophen to alert health care providers of a possible association between its use during pregnancy and an increased risk of attention-deficit/hyperactivity disorder (ADHD) and autism spectrum disorder in children. Despite this move, the agency and leading medical experts agree that a causal relationship has not been established.^1,2

The FDA’s action is based on several smaller studies that have suggested a correlation. However, major medical organizations such as the American College of Obstetricians and Gynecologists have strongly contested this decision, labeling it “irresponsible.” They point to significant methodological flaws in the cited research, such as a failure to control for confounding family and genetic factors.²

Experts highlight a much larger and more robust 2024 study published in JAMA that followed nearly 2.5 million children in Sweden. Using a sibling control model to account for confounding variables, the study found no evidence of an association between prenatal acetaminophen use and autism, ADHD, or intellectual disability.³

For pharmacists, this conflicting information requires careful patient counseling. Acetaminophen remains the only FDA-approved OTC medication to treat fever in pregnant individuals, as other common analgesics are not recommended.⁴ The health risks to a fetus from an untreated high fever during pregnancy are well documented and significant. Pharmacists should reassure patients that high-quality evidence does not support a causal link and that the safe management of fever and pain during pregnancy remains a priority.

REFERENCES

1. FDA responds to evidence of possible association between autism and acetaminophen use during pregnancy. FDA. News release. September 22, 2025. Accessed September 23, 2025. https://www.fda.gov/news-events/press-announcements/fda-responds-evidence-possible-association-between-autism-and-acetaminophen-use-during-pregnancy?utm_medium=email&utm_source=govdeliveryFjnk

2. Fleischman J. ACOG affirms safety and benefits of acetaminophen during pregnancy. American College of Obstetricians and Gynecologists. News release. September 22, 2025. Accessed September 23, 2025. https://www.acog.org/news/news-releases/2025/09/acog-affirms-safety-benefits-acetaminophen-pregnancy

3. Ji Y, Azuine RE, Zhang Y, et al. Association of cord plasma biomarkers of in utero acetaminophen exposure with risk of attention-deficit/hyperactivity disorder and autism spectrum disorder in childhood. JAMA Psychiatry. 2020;77(2):180-189. doi:10.1001/jamapsychiatry.2019.3259

4. March of Dimes. Can having a fever while pregnant hurt my baby? Published March 30, 2021. Accessed September 23, 2025. https://www.marchofdimes.org/find-support/blog/can-having-fever-while-pregnant-hurt-my-baby