Pharmacy Practice NewsFDA Rescinds EUA but Approves Updated 2025-2026 COVID Vaccines

The FDA rescinded COVID-19 vaccine EUAs while approving 2025-2026 JN.1-lineage formulations with restricted indications: adults 65+ and high-risk individuals 5-64 years. This contradicts AAP, IDSA, and CDC recommendations supporting broader vaccination. The policy shift limits pharmacist off-label authority while physicians retain prescribing rights, creating operational challenges for pharmacy-based vaccination programs during respiratory virus season.

⚖️ Professional Impact Points

• Pharmacist off-label prescribing authority severely constrained under new labeling, unlike physicians who retain broader rights, limiting pharmacy vaccination programs serving as primary community access points.
• Liability concerns arise from FDA restrictions conflicting with AAP, IDSA, CDC recommendations, requiring pharmacists to navigate contradictory guidance when counseling families requesting vaccines for healthy children.
• Insurance coverage uncertainty for off-label vaccination creates administrative burdens as payers may deny claims outside FDA-approved populations despite medical society endorsement.
• Patient communication challenges intensify as pharmacists explain restricted access, address HHS messaging contradicting scientific consensus, and manage parent confusion about pediatric vaccination.
• Regulatory precedent restricting vaccine access based on policy versus evidence undermines pharmacy’s public health role, potentially signaling future limitations on pharmacist-administered preventive services.

🏥 Practice Management Considerations

• Documentation Strategy: Establish protocols for off-label vaccination discussions, medical necessity justification, informed consent, and physician collaboration to protect against liability and reimbursement denials.
• Insurance Workflows: Communicate with payers to clarify coverage policies, develop appeal processes, and create patient financial assistance resources for denied claims.
• Staff Training: Train teams on indication restrictions, state scope limitations, physician referral pathways, and communication scripts addressing policy contradictions and parent concerns.
• Patient Communication: Develop messaging distinguishing FDA restrictions from medical society recommendations and explaining pharmacist versus physician prescribing authority differences.

HCN Medical Memo
Maintain evidence-based vaccination practices consistent with IDSA, AAP, CDC guidance while communicating FDA restrictions. Establish physician collaboration agreements for off-label access. Engage state associations to preserve pharmacist authority and communicate with insurers to maintain coverage aligned with clinical guidelines.

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