Our Continued Innovation at Work: Celebrating U.S. FDA Approval of Our Updated COVID-19 Vaccine

Stéphane Bancel

Chief Executive Officer

I am pleased to announce that the U.S. Food and Drug Administration (FDA) has approved our supplemental Biologics License Application (sBLA) for Spikevax® (COVID-19 Vaccine, mRNA) for individuals 12 years of age and older, which helps protect against the most dominant variants as recommended by the June 2023 FDA VRBPAC. This timely approval helps ensure everyone will have the tools they need to do their part in protecting themselves and slowing the spread of the virus as we head into the fall and winter months in the U.S.

My deepest gratitude goes to the Moderna team for their work to reach this significant milestone and for their relentlessness in the continued fight against COVID-19. In three years, we have received a full regulatory approval for our COVID-19 vaccine, advanced not one, but two variant-targeted COVID-19 vaccines in record time, and delivered the vaccine to millions of people during the pandemic.¹ Our team’s vigilance and proactivity in tackling the latest threats means we can provide an essential piece of protection as we enter peak respiratory virus season, especially in light of rising hospitalization rates over the last several weeks.

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This approval is yet another example of what our mRNA platform can accomplish with incredible speed, scale and flexibility. At Moderna, we have been studying mRNA and its various applications across a broad range of therapeutic areas for more than 12 years. Our mRNA platform offers a solid foundation for us to quickly pivot and prioritize the most pressing public health needs as they emerge.

On the heels of this exciting milestone, I would also like to express my thanks and appreciation to our government and manufacturing partners, and our suppliers for their dedication to making this year’s updated COVID-19 vaccine a reality. We have worked together to build a robust global supply of the vaccine and study it in emerging variants of concern, including EG.5, FL.1.5.1 and BA.2.86.² I am grateful for your contributions in protecting the population from COVID-19.

What’s Next

In the U.S., we expect Spikevax to be at pharmacies and care settings in the coming days. Once available, we encourage the public to get both their updated COVID-19 vaccine and flu vaccine this fall. Outside of the U.S., regulatory applications for our updated COVID-19 vaccine are under review and we expect to share an update in the coming weeks.

This is a proud moment for us all at Moderna, but we know there is much more to do as we work to deliver the greatest possible impact to people through mRNA medicines.

Thank you for your continued trust and support as we continue the fight against COVID-19.

INDICATION (U.S.)

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

- Do not administer the vaccines to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.

- Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the vaccine.

- Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following vaccination.

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

- Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to the vaccine.

- The vaccine may not protect all vaccine recipients.

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

- The vaccination provider is responsible for mandatory reporting of certain adverse events to the Vaccine Adverse Event Reporting System (VAERS) online at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967.

Please see the SPIKEVAX full Prescribing Information.

References

https://www.modernatx.com/en-US/responsibility/our-commitment https://investors.modernatx.com/news/news-details/2023/Moderna-Clinical-Trial-Data-Confirm-Its-Updated-Covid-19-Vaccine-Generates-Strong-Immune-Response-in-Humans-Against-BA.2.86/default.aspx