Spikevax® (COVID-19 Vaccine, mRNA) 2024-2025 Formula by Moderna is Now Available to Order

We’re pleased to announce that the U.S. Food and Drug Administration (FDA) has approved our Biologics License Application (BLA) for Spikevax® (COVID-19 Vaccine, mRNA) 2024-2025 Formula for individuals aged 12yr+. The product is now FDA-approved.

The 2024-2025 vaccine is designed to protect against actively circulating variants, consistent with VRBPAC guidance.

Here’s what’s new:

  • Spikevax has been updated to help protect against actively circulating variants, and the 2024-2025 formula is designed to protect against the Omicron variant’s KP.2 sublineage.

  • Spikevax is now available in a pre-filled syringe (and no longer available in single-dose vials).

  • The 2024-2025 storage requirements for the Spikevax pre-filled syringe are:

INDICATION

SPIKEVAX (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

IMPORTANT SAFETY INFORMATION

Contraindications

Do not administer SPIKEVAX to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of SPIKEVAX or to individuals who had a severe allergic reaction (e.g., anaphylaxis) following a previous dose of a Moderna COVID-19 vaccine.

Warnings and Precautions

  • Management of Acute Allergic Reactions: Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of SPIKEVAX.

  • Myocarditis and Pericarditis: Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following vaccination. The observed risk is highest in males 18 through 24 years of age.

  • Syncope (fainting): May occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.

  • Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to SPIKEVAX.

  • Limitations of Vaccine Effectiveness: SPIKEVAX may not protect all vaccine recipients.

Adverse Reactions

The most commonly reported (≥10%) adverse reactions following any dose in any indicated patient population were pain at the injection site, fatigue, headache, myalgia, chills, arthralgia, axillary swelling/tenderness, nausea/vomiting, and swelling at the injection site.

Reporting Adverse Events and Vaccine Administration Errors

To report suspected adverse reactions, contact ModernaTX, Inc. at 1-866-663-3762 or VAERS at 1-800- 822-7967 or www.vaers.hhs.gov.

For Colorado and Connecticut price disclosure, please visit
https://modernadirect.com/wac-disclosure.

Click here for SPIKEVAX Full Prescribing Information.

If you have any questions about Spikevax or ordering directly from Moderna, please feel free to contact our Customer Care Team at
1-800-MODERNA (1-866-663-3762) Monday - Friday 8:00 AM to 8:00 PM ET (closed holidays) or by sending a message to WeCare@modernatx.com.

Thank you for your continued dedication to public health.

Best Regards,
Moderna

References:1. FDA, “FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants.” Updated August 22, 2024. Accessed August 22, 2024. 2. FDA, “Updated COVID-19 Vaccines for Use in the United States Beginning in Fall 2024. Updated.” Updated August 13, 2024. Accessed August 21, 2024. 3. Spikevax. Prescribing Information. ModernaTX, Inc., 2024.