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.
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.
Coding for COVID-19 vaccines can be complicated, with specific codes for vaccine presentations, patient age, and dose administered. But finding the right codes for Moderna’s products just got easier.
When using the tool, simply answer a few questions, and it will generate the codes you need. Then, just copy and paste them into your EMR or print the codes for future reference.
To retrieve updated coding as new presentations are introduced, make sure you bookmark the page.
Moderna is here to support your immunization efforts. Ensure your team is ready for the upcoming COVID-19 season by reserving your vaccine supply today.
Click the links below for more information:
2024-2025 Expected Presentation: Spikevax (COVID-19 Vaccine, mRNA) - 12 years of age and older
As we navigate a world where COVID-19 is one of many health concerns, your commitment to patient care remains invaluable. Your expertise and counsel continue to play a crucial role in disease prevention and patient health.
With the number of COVID-19 hospitalizations topping 19,000 the week of November 19 – 25, 2023, vigilance and preventative measures remain essential. The ACIP continues to recommend updated COVID vaccines for all patients aged 6 months and older, and your guidance can make a powerful difference.
To assist you, Moderna has assembled a concise resource that sheds light on the latest research and the importance of extended vigilance in combatting the spread of the SARS-CoV-2 virus.
The role of healthcare professionals is pivotal in guiding vaccine decisions. Studies show that messages involving a personal physician or a scientist recommending vaccination were the most compelling ways to improve vaccine adherence.
Together, we continue to strive to protect patients from COVID-19. Thank you for your relentless dedication and the difference you make every day.
For inquiries call 1-866-MODERNA (1-866-663-3762).
Important Announcement from Moderna:
Moderna is pleased to announce an important update to their vaccine return policy that they hope will have a positive impact on pediatric health and immunization rates.
Effective immediately, all privately purchased pediatric COVID-19 vaccine doses (NDC No. 80777-0287-92) purchased on or after January 9, 2024 will be 100% returnable for the entire season, pursuant to the return policies and procedures provided in your contract with Moderna.
This change is part of Moderna’s commitment to support healthcare providers and ensure that all children under the age of 12 have access to the COVID-19 vaccine.
Moderna understands the challenges faced by providers in predicting the exact number of doses needed. By allowing for increased returnability of unused pediatric COVID-19 vaccines, Moderna aims to eliminate the risk of unused excess supply for providers and encourage them to keep a healthy stock on-hand without the worry of excess inventory.
Let's work together to keep our children safe and healthy.
Many caregivers feel there’s no serious COVID-19 risk for their children, but hospitalizations and deaths persist in this age group, even without comorbidities.
Please join Moderna along with a panel of national experts on Tuesday, December 5, 2023 at 12:00 p.m. EST for a live, virtual event discussing COVID-19 and kids.
Topics will include:
The burden of pediatric COVID-19
Factors associated with severe outcomes
Past versus current vaccination uptake
Pediatric-specific risks and benefits
Common caregiver questions
In order to receive a webinar replay link, you must be registered for the event.
