CurrentIndependent HealthPolicy N/A

Standing order for administration of Moderna COVID-19 Vaccine (2025-2026 Formula, SPIKEVAX) by pharmacists

Statewide New York non-patient specific standing order authorizing pharmacists in licensed NY pharmacies to administer the Moderna COVID-19 Vaccine (2025-2026 Formula, SPIKEVAX) to eligible individuals aged 3 years and older under specified conditions and regulatory requirements.

Policy Summary

PayerIndependent Health

PolicyStanding order for administration of Moderna COVID-19 Vaccine (2025-2026 Formula, SPIKEVAX) by pharmacists

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionAssess vaccination status and follow age- and immunocompromise-specific dosing guidance; if previously vaccinated, administer approximately 2 months after the last COVID-19 vaccine.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3minimum age for administration

0.25/0.5 mLsyringe sizes

2 monthsmin interval after prior vaccine

Sept 5, 2025 - Sept 4, 2026order effective period

Coverage & Administration Criteria

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inv-01: Eligibility and dosing

Covered when ALL of the following are met

Standing order prerequisites: Pharmacist is an employee/volunteer/contractor of a New York State licensed pharmacy and is authorized to administer vaccines under applicable NYS certification; administration follows FDA approval/EUA and applicable federal/state law and the standing non-patient-specific order.

supports: chunks 4,36

Eligible recipient groups: Individuals meeting at least one of: age ≥65 years; age 6 months through 64 years with ≥1 underlying condition that increases risk for severe COVID-19 (see Table 1 for list); those who self-attest to being moderately or severely immunocompromised; persons aged ≥3 years per age-specific dosing guidance.

supports: chunks 11,12,51-55

Age and dose definitions: For persons ages 3 through 11 years: single dose = 0.25 mL; for persons age 12 years and older: single dose = 0.50 mL. Vaccine supplied as prefilled single-dose frozen syringes for intramuscular use.

supports: chunk 16,38

Interval since prior COVID-19 vaccination: If previously vaccinated with any COVID-19 vaccine, administer this dose approximately 2 months after the last COVID-19 vaccine dose.~2 months

supports: chunks 18,19

inv-02: Dosing and interval schedules by prior vaccine history

Dose and interval guidance by prior COVID-19 vaccination history and age:

Unvaccinated (ages 3-11, immunocompetent): Indicated number of 2025-2026 Moderna doses = 4; Dosage = 0.25 mL. Schedule: Dose 1 = Day 0; Dose 2 = 4 weeks after Dose 1; Dose 3 = 4 weeks after Dose 2; Dose 4 = at least 6 months after Dose 3 (minimum interval 2 months).

chunk refs: 20,25

Unvaccinated (ages ≥12 or immunocompromised older groups): Indicated number of 2025-2026 Moderna doses = 4; Dosage = 0.50 mL. Schedule: Dose 1 = Day 0; Dose 2 = 4 weeks after Dose 1; Dose 3 = 4 weeks after Dose 2; Dose 4 = at least 6 months after Dose 3 (minimum interval 2 months).

chunk ref: 29

Previous 1 dose Moderna: Indicated number of 2025-2026 Moderna doses = 3; Dosage age-dependent (0.25 mL for ages 3–11; 0.50 mL for ≥12). Schedule: Dose 1 = at least 4 weeks after previous dose; Dose 2 = at least 4 weeks after Dose 1; Dose 3 = at least 6 months after Dose 2 (minimum interval 2 months).

chunk refs: 20,25,29

inv-03: Coverage / Administration Criteria

Covered when the following are met:

Eligibility and documentation: Patient is age 3 years or older; pharmacists administering vaccine are employees/volunteers/contractors of a NY-licensed pharmacy operating under the standing non-patient-specific order; required screening, informed consent and Vaccine Information Statement (VIS) provided; required vaccination documentation and reporting completed per NY requirements.

Order effective 9/5/2025–9/4/2026; supports: chunks 36,41-42

Dose volume by age: If patient age 3–11 years administer 0.25 mL; if patient age ≥12 years administer 0.50 mL.

Intramuscular administration in deltoid (anterolateral thigh alternate). Supports: chunks 16,39

High-risk indication note: FDA approval language includes use in ages 3–64 years with ≥1 underlying condition that increases risk for severe COVID-19 and in persons ≥65 years; underlying conditions include (but are not limited to) asthma, cancer (including hematologic malignancies), cerebrovascular disease, chronic kidney disease (including dialysis), chronic lung diseases, chronic liver disease, cystic fibrosis, diabetes (type 1 and 2), disabilities (including Down syndrome), epilepsy, hemophilia, and heart conditions.

inv-04: Observation Periods

Post-vaccination observation recommendations:

Observation duration: Observe for 30 minutes for people with history of a non-severe immediate (<4 hours) allergic reaction to a prior COVID-19 vaccine, history of an allergy-related contraindication to a different COVID-19 vaccine, or history of anaphylaxis to non-COVID injectable therapies; observe all other people for 15 minutes.

supports: chunk 43

This standing order authorizes intramuscular administration of the Moderna COVID-19 Vaccine (2025-2026 Formula, SPIKEVAX) supplied as prefilled, single-dose syringes only. The product is provided frozen in 0.25 mL and 0.50 mL presentations and the standing order applies to those prefilled single-dose syringes administered intramuscularly; other formulations are not described in this portion of the order.

Screen patients for a history of severe allergic reaction prior to vaccination. A history of a severe allergic reaction (for example, anaphylaxis) after a previous dose of Moderna vaccine or to a component of the Moderna COVID-19 vaccine is a contraindication to administration under this order; exercise caution and follow contraindication guidance if such a history is identified.

The document does not list a separate, explicit exclusion list beyond the contraindication for prior severe allergic reaction. Providers must follow FDA product information and state/federal guidance for any additional contraindications or product-specific exclusions and communicate FDA approval status, risks/benefits, and alternatives to the recipient or caregiver prior to administration.

No additional exclusions are specified in these referenced sections. Providers should refer to the CDC and the product fact sheet for full lists of underlying conditions, pediatric evidence notes, and any condition-specific guidance.

Not explicitly stated in this portion of the document.

No not-medically-necessary items are specified in these chunks of the document.

Provider Responsibilities & Documentation

Prior Authorization

No prior authorization is required for administration of the Moderna COVID-19 Vaccine (2025-2026 Formula) under this non‑patient specific standing order. Vaccine administration is authorized when the pharmacist meets the standing order and certification requirements described herein.

Standing order valid 9/5/2025–9/4/2026

Documentation Required

Regulatory Compliance Requirement

Pharmacists must follow the requirements set forth in 8 NYCRR §§63.9 and 64.7, including providing patients with requisite information, maintaining adequate records, and adhering to reporting requirements. Failure to comply may constitute regulatory noncompliance and could expose the provider or pharmacy to enforcement actions.

Provide required patient information per 8 NYCRR §§63.9 & 64.7
Maintain records in retrievable format and retain as required
Adhere to state reporting requirements, including NYSIIS/CIR and CDMS as applicable

Denial Risk

Contraindication — Anaphylaxis

Do not administer the vaccine to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose of Moderna vaccine or to a component of the Moderna COVID-19 vaccine. Screen each patient for this contraindication prior to vaccination.

Contraindication: anaphylaxis after prior Moderna dose or to a component

Note

Authorization Scope

Authorization to administer under this standing order is limited to pharmacists who are employees, volunteers, or contractors of a pharmacy licensed in New York State, who hold a certificate of administration from the NYS Department of Education authorizing vaccine administration under non‑patient specific standing orders, and who are certified in cardiopulmonary resuscitation (CPR). Administration must conform to the standing order's scope and applicable federal/state authorizations.

Pharmacist must be employee/volunteer/contractor of NY licensed pharmacy
Must hold NYS Department of Education certificate for vaccine administration under non‑patient specific standing orders
Must be certified in CPR
Administer only per the non‑patient specific standing order and applicable FDA/state/federal authorizations

Note

No Denial Triggers Present

There are no specific denial triggers beyond the clinical contraindications and requirements noted in this standing order. If vaccine is not administered, record the reason (e.g., medical contraindication, patient refusal) in the medical record.

If vaccine not administered, document reason(s) for non‑receipt (medical contraindication, refusal)

Documentation Required

Required Documentation & Reporting

Document each vaccination in the patient's medical record (and CDMS, as applicable) within 24 hours. Include patient name, date administered, vaccine name, manufacturer and lot number, vaccination site and route, address of administering site, and the name and title of the authorized person who administered the vaccine. Provide a signed Certificate of Immunization to the patient and report doses to NYSIIS/CIR per age and consent rules.

Document: patient name; date; vaccine name; manufacturer and lot number; vaccination site and route; administering site address; name and title of vaccinator
Complete documentation within 24 hours and retain per 8 NYCRR §29.2(a)(3)
Provide Signed Certificate of Immunization to patient with required details
Report all doses for ages ≤18 to NYSIIS/CIR within 14 days; report doses for ≥19 to NYSIIS/CIR after obtaining consent; follow CDMS→NYSIIS transmission rules as applicable

Initial and Booster Dosing Rules

inv-32: Initial and booster dosing

Dosing and timing for initial and booster doses

Dose by age: 3–11 years: 0.25 mL per single intramuscular dose; ≥12 years: 0.50 mL per single intramuscular dose (prefilled single‑dose syringes).

supports: chunks 16,38

Timing after prior vaccine: If previously vaccinated with any COVID-19 vaccine, administer subsequent 2025–2026 Moderna dose approximately 2 months after the last COVID-19 vaccine dose.~2 months

supports: chunks 18,19

inv-33: Initial series

Initial vaccine series by vaccination history and age

Unvaccinated children (3-11): Primary/initial schedule: 4 doses of 0.25 mL each. Timing: Dose 1 = Day 0; Dose 2 = 4 weeks after Dose 1; Dose 3 = 4 weeks after Dose 2; Dose 4 = at least 6 months after Dose 3 (minimum interval 2 months).

supports: chunks 20,25

Unvaccinated adolescents/adults (≥12): Primary/initial schedule: 4 doses of 0.50 mL each. Timing: Dose 1 = Day 0; Dose 2 = 4 weeks after Dose 1; Dose 3 = 4 weeks after Dose 2; Dose 4 = at least 6 months after Dose 3 (minimum interval 2 months).

supports: chunk 29

Definitions & Notes

inv-28: SPIKEVAX (2025-2026 Formula) — Moderna COVID-19 Vaccine (2025-2026 Formula) / SPIKEVAX

Product name(s)Moderna COVID-19 Vaccine (2025-2026 Formula) — SPIKEVAX

Variant basisMonovalent formulation based on Omicron sublineage LP.8.1

Packaging and supplyPrefilled single-dose frozen syringes in 0.25 mL and 0.5 mL volumes

inv-29: Immunocompromised considerations — vaccinate without delay for immunosuppressed; timing relative to therapy initiation

General guidance for immunosuppressed patientsDo not delay COVID-19 vaccination for patients on immunosuppressive therapies; vaccinate when available

Timing before initiation of immunosuppressionWhen possible, administer ≥2 weeks before initiation or resumption of immunosuppressive therapy

B-cell–depleting therapy timingFor patients on continuing B-cell–depleting therapy, administer approximately 4 weeks before the next scheduled therapy

HCT/CAR-T revaccinationRevaccinate following current schedule starting ≥3 months (12 weeks) after transplant or CAR-T therapy

inv-30: Recipient counseling — provider must communicate FDA approval status, risks/benefits, and alternatives prior to vaccination

Required counseling topicsInform recipient/caregiver that FDA has approved the Moderna (2025-2026) vaccine for ages 3–64 years with ≥1 high-risk condition and for ages ≥65; recipient may accept or refuse

Risks and benefitsExplain significant known and potential risks and benefits and the extent to which risks/benefits are unknown

Alternative vaccinesProvide information about available alternative vaccines and their risks/benefits

inv-31: Pediatric evidence indication — underlying conditions with pediatric evidence indicated and documented in CDC reference

Reference sourceCDC: Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19 (accessed 9/4/2025)

Provider actionDocument pediatric evidence indication as shown in CDC reference when assessing underlying conditions

OpenPayer

Standing order for administration of Moderna COVID-19 Vaccine (2025-2026 Formula, SPIKEVAX) by pharmacists

Coverage & Administration Criteria

Provider Responsibilities & Documentation

Initial and Booster Dosing Rules

Dose Volume & Quantity Limits

Where and How to Administer

Definitions & Notes

Background