RSV mRESVIA Label Update and Resources

Moderna has updated several mRESVIA resources to align with recent label changes. Please see details below:

  • Refrigeration Duration: Updated from 30 days to 90 days.

  • Refrigeration Thaw Duration:

    • For 1 carton: Updated from 60 minutes to 100 minutes.

    • For a carton of 10: Updated from 155 minutes to 160 minutes.

  • Room Temperature Thaw Duration:

    • For 1 carton: Updated from 45 minutes to 40 minutes.

    • For a carton of 10: Updated from 160 minutes to 80 minutes.

ACIP Updated Recommendations for Receipt of COVID-19 Vaccines

On October 23, 2024, the Advisory Committee on Immunization Practices (ACIP) updated its recommendations for receipt of COVID-19 vaccines. In addition to its previous recommendations for 2024-2025 vaccines, ACIP recommends (1):

  •  A second dose* of 2024-2025 COVID-19 vaccine for adults ages 65 years and older

  • A second dose† of 2024-2025 COVID-19 vaccine for people ages 6 months to 64 years who are moderately or severely immunocompromised

  • Additional doses (i.e., 3 or more doses) of 2024-2025 COVID-19 vaccine for people ages 6 months and older who are moderately or severely immunocompromised, under shared clinical decision making

*If previously unvaccinated and receiving Novavax, 2 doses are recommended as initial vaccination series followed by a third dose of any age-appropriate 2024-2025 COVID-19 vaccine 6 months (minimum interval 2 months) after second dose.1

†If previously unvaccinated or receiving initial vaccination series, a multidose vaccination series with an age-appropriate 2024- 2025 vaccine is recommended. This additional 2024-2025 vaccine dose is recommended 6 months (minimum interval 2 months) after completion of initial vaccination series.1

The Director of the Centers for Disease Control and Prevention has adopted these recommendations and has made them official.

We support your efforts to help protect vaccine-eligible patients from COVID-19. Please consider ACIP’s updated recommendations when identifying vaccine-eligible patients and forecasting demand for vaccines and talk with us about ensuring that you have an adequate stock of 2024-2025 formula COVID- 19 vaccines.

Reference:

(1) Centers for Disease Control and Prevention. Interim clinical considerations for use of COVID-19 vaccines in the United States. Updated October 31, 2024. Accessed November 1, 2024. https://www.cdc.gov/vaccines/covid-19/clinical- considerations/interim-considerations-us.html

Pfizer's Reminder Recall Resources are Available

There may be gaps in immunization coverage for your patients that leave them at risk for certain vaccine-preventable diseases.  The ACIP, AAP, and AAFP recommend the use of reminder recall systems by vaccination providers to increase vaccination rates.  

Pfizer offers reminder recall resources that may help support your organization's efforts to increase vaccination and well visit adherence through personalized postcards that can assist in your vaccination outreach efforts.  These postcards are not brand-specific and are intended for your patients who may have missed or are due for CDC-recommended vaccines, or who may be due for a well visit.

 To learn more, click here and share your contact information via email to request a call from a Pfizer Vaccines representative to review Pfizer's reminder recall resources and the program enrollment process.  As a note, by providing your contact information, you are therefore affirming your consent to provide your contact information to a local Pfizer Vaccine Representative.  

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.