Follow-Up Update: CDC Clarifies 2026-2027 COVID-19 Vaccination Recommendations

We are writing to provide an important update to our August 20 and September 2, 2026 communications regarding federal vaccine recommendations and their potential impact on pharmacy vaccine administration authority, standing orders, and protocols.

On September 23, 2026, the Centers for Disease Control and Prevention (CDC) issued updated “Interim Clinical Considerations for Use of COVID-19 Vaccines in the United States” for the 2026-2027 respiratory illness season. In light of the continuing legal uncertainty surrounding federal vaccine recommendations, the CDC clarified that the COVID-19 vaccination recommendations reflected in the July 2025 adult and pediatric immunization schedules remain in effect for the 2026-2027 season.

Under this guidance:

• A 2026-2027 COVID-19 vaccine is recommended for all adults 18 years of age and older.
• A 2026-2027 COVID-19 vaccine is recommended for children 6 months through 17 years of age who are moderately or severely immunocompromised.
• For other children 6 months through 17 years of age, COVID-19 vaccination is recommended through shared clinical decision-making between the parent or legal guardian and a healthcare professional.
• The recommended vaccine product and number of doses depend upon the patient’s age, vaccination history, and immune status.

For children who are not moderately or severely immunocompromised, the CDC states that the balance of benefits and risks is most favorable for those at increased risk for severe COVID-19 and lowest for those who are not at increased risk.

Additionally, the CDC specifically states that people can self-attest to their moderately or severely immunocompromised status and receive COVID-19 vaccine doses wherever vaccines are offered. Vaccinators should not deny COVID-19 vaccination to a person due to lack of documentation.

The updated guidance also reflects current FDA regulatory information for the 2026-2027 vaccine products. Certain CDC recommendations, such as vaccinating patients with no underlying condition that places them at high risk for severe COVID-19 outcomes, may extend beyond a product’s FDA-approved indication. The CDC identifies these circumstances as off-label use within its vaccination schedules and clinical guidance. Pharmacies should therefore carefully review the applicable product, age range, risk indication, vaccination history, and CDC schedule before administering a 2026-2027 COVID-19 vaccine.

The CDC identifies the following FDA-approved vaccines and indications:

• Spikevax (mRNA vaccine): Individuals 65 years of age and older, and individuals 6 months through 64 years of age with at least one underlying condition that places them at high risk for severe COVID-19 outcomes.
• mNexspike (mRNA vaccine): Individuals 65 years of age and older, and individuals 12 through 64 years of age with at least one underlying condition that places them at high risk for severe COVID-19 outcomes.
• Comirnaty (mRNA vaccine): Individuals 65 years of age and older, and individuals 5 through 64 years of age with at least one underlying condition that places them at high risk for severe COVID-19 outcomes. There is currently no FDA-approved or FDA-authorized Pfizer-BioNTech COVID-19 vaccine for children 6 months through 4 years of age.
• Novavax (protein subunit vaccine): Individuals 65 years of age and older, and individuals 12 through 64 years of age with at least one underlying condition that places them at high risk for severe COVID-19 outcomes.

This CDC clarification is significant because it provides healthcare professionals with COVID-19 vaccination guidance for the 2026-2027 season while the broader legal uncertainty discussed in our August 20, 2026 communication continues. It does not, however, eliminate the need to evaluate pharmacist vaccination authority under applicable state law.

As noted in our prior communications, pharmacist authority to administer COVID-19 vaccines may depend upon state statutes and regulations, patient age, vaccine type, CDC or ACIP recommendations, a prescription, standing order, collaborative practice agreement, or other state-specific requirements. Pharmacies should not assume that the CDC recommendation alone authorizes every pharmacist to administer every recommended vaccine in every jurisdiction.

Accordingly, we recommend that pharmacies:

• Review the CDC’s 2026-2027 COVID-19 vaccination schedules before administering a vaccine.
• Verify that the selected vaccine is appropriate for the patient’s age, vaccination history, and immune status.
• Identify situations in which the CDC recommendation represents off-label use outside the vaccine’s FDA-approved indication.
• Review applicable state laws, regulations, and Board of Pharmacy guidance regarding pharmacist vaccination authority.
• Confirm that existing standing orders, protocols, and collaborative practice agreements are consistent with the updated CDC guidance and applicable state requirements.
• Use shared clinical decision-making and appropriate documentation when vaccinating children who are not moderately or severely immunocompromised.
• Verify payer coverage and billing requirements, particularly when the contemplated use is outside the product’s FDA-approved indication.

R.J. Hedges & Associates will continue to monitor CDC guidance, FDA regulatory actions, ACIP activities, federal litigation, and state regulatory developments. We will evaluate whether revisions to our COVID-19 standing orders, protocols, or related compliance documents are warranted as additional information becomes available.

As always, please contact us if you have questions regarding your pharmacy’s vaccine compliance program, standing orders, or protocols.

R.J. Hedges & Associates
Pharmacy Compliance Team

Reference

• CDC Interim Clinical Considerations for Use of COVID-19 Vaccines in the United States
• CDC 2026-2027 COVID-19 Vaccination Guidance for People Who Are Not Immunocompromised
• CDC COVID-19 Vaccination Guidance for People Who Are Immunocompromised
• CDC Overview of COVID-19 Vaccines and Vaccination

Disclaimer: This communication is intended for educational and compliance awareness purposes only and does not constitute legal advice. Pharmacies should consult qualified legal counsel and applicable state regulatory authorities regarding state-specific requirements.

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