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Prescribing information for Spikevax (COVID-19 Vaccine, mRNA) 2024-2025 Formula


FAQ

Have questions about Moderna vaccines? Browse the topics below to find the answers to some of the most frequently asked questions about placing, tracking, and receiving orders. If your question isn't addressed, our Customer Care Team is just a call away at 1-866-MODERNA (1-866-663-3762), or available by email at WeCare@modernatx.com.

Please contact our Customer Care Team at 1-866-MODERNA (1-866-663-3762) or email WeCare@modernatx.com.

In order to give you more control over your reservations, we have enabled a feature to allow ModernaDirect.com customers to edit their vaccine reservations directly through the website.

To edit your reservation:

  1. Navigate to your order history.
  2. Select the reservation you wish to modify.
  3. Input your new reservation details.

Moderna works with several Authorized Distributors to ensure a smooth customer experience. Customers who order through these distributors are considered "indirect customers."

TThe price shown on the site is per dose, however you must order in quantities of 10 (a single carton). This is based on either the list price or the price available to you through your contract affiliation.
Yes. In the Quick Order Form, click “DELIVER TO ADDITIONAL ADDRESS” to select an existing address or add a new address. For each shipping address, select the number of cartons you want delivered to each location.
Small parcel orders are shipped in insulated containers (with gel packs) that have been validated to maintain the proper temperature for the duration of the shipment. For COVID vaccines, this temperature is between 50°C and -15°C (-58°F and 5°F); for RSV vaccines it is -40°C to –15°C (-40°F to 5°F).

Truck deliveries contain Sensitech Temperature Monitoring Devices. Refer to the diagram here for details on the device.

If you placed your order directly with Moderna, please contact the Moderna Customer Care Team at 1-866-MODERNA (1-866-663-3762) or email WeCare@modernatx.com.

If you placed your order via an Authorized Distributor please contact them for assistance.

If the order was placed directly with Moderna, either on ModernaDirect.com or the Contact Center, please contact our Customer Care Team at 1-866-MODERNA (1-866-663-3762) or email WeCare@modernatx.com.

If you’re an indirect customer with questions regarding temperature excursions or vaccine viability, contact your Authorized Distributor.

If you need to return vaccines because there was a problem with your shipment (such as a temperature excursion), please contact our Customer Care Team at 1-866-MODERNA (1-866-663-3762) or email WeCare@modernatx.com.

The policy for end-of-season returns of unused products will vary by contract. Please consult your contract for more information about return eligibility and guidelines or contact our Customer Care Team at 1-866-MODERNA (1-866-663-3762) or email WeCare@modernatx.com if you still have questions.

See the full Return Policy.

Indication and Important Safety Information

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 (SARSCoV-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.

Please click for SPIKEVAX Full Prescribing Information.

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