FDA Issues Full Approval for Moderna COVID-19 Vaccine

The 2-dose Spikevax COVID-19 vaccine was approved by the FDA based on a comprehensive submission package including efficacy and safety data approximately 6 months after the second dose.

Moderna has received full FDA approval for its vaccine to prevent COVID-19 in individuals 18 years of age and older, according to a company press release.

The 2-dose vaccine, called Spikevax, was approved based on a comprehensive submission package including efficacy and safety data approximately 6 months after the second dose. According to the press release, 807 million doses of the vaccine were shipped globally in 2021, approximately 25% of which were shipped to low- and middle-income countries.1

“Our COVID-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from COVID-19 infection, hospitalization, and death,” said Stephane Bancel, CEO of Moderna, in the press release. “The totality of real-world data and the full [Biologics License Application] for Spikevax in the United States reaffirms the importance of vaccination against this virus.”1

The FDA decision is based on scientific evidence including follow-up data from the phase 3 COVE study, which showed high efficacy and a favorable safety profile approximately 6 months after the second dose.1 Research has also found that 2 doses of the vaccine were highly effective against all SARS-CoV-2 variants, although the vaccine’s efficacy against the delta variant slightly waned over time.

In final analysis of the phase 3 COVE study data, the vaccine showed 93% efficacy, which remained durable through 6 months after administration of the second dose. Reported adverse reactions included pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea or vomiting, axillary swelling or tenderness, fever, swelling at the injection site, and erythema at the injection site.2

The approval does not include a booster dose, although researchers have found encouraging results with booster candidates at 50 µg and 100 µg levels. The 50 µg dose is currently authorized and has shown an approximately 37-fold increase in neutralizing antibody levels against the omicron variant, according to Moderna. Furthermore, the 100 µg booster dose has shown an approximately 83-fold increase in antibody levels against the Omicron variant, according to Moderna.3

The main 2-dose vaccine series was available under Emergency Use Authorization (EUA) in the United States starting December 18, 2020. A 50 µg booster dose is authorized for emergency use under EUA for adults 18 years of age and older. Furthermore, a third 100 µg dose is authorized for emergency use in immunocompromised individuals 18 years of age or older who have undergone solid organ transplantation, or who are diagnosed with conditions that have an equivalent level of immunocompromise.1

“The full licensure of Spikevax in the US now joins that in Canada, Japan, the European Union, the UK, Israel, and other countries, where the adolescent indication is also approved,” Bancel said in the press release. “We are grateful to the US FDA for their thorough review of our application. We are humbled by the role that Spikevax is playing to help end this pandemic.”1

REFERENCES

  1. Moderna Receives Full US FDA Approval for COVID-19 Vaccine Spikevax. Moderna. News release. January 31, 2022. Accessed January 31, 2022. https://investors.modernatx.com/news/news-details/2022/Moderna-Receives-Full-U.S.-FDA-Approval-for-COVID-19-Vaccine-Spikevax/default.aspx
  2. Moderna Completes Submission of Biologics License Application to the US Food and Drug Administration for Its COVID-19 Vaccine. Moderna. News release. August 25, 2021. Accessed January 31, 2022. https://investors.modernatx.com/news/news-details/2021/Moderna-Completes-Submission-of-Biologics-License-Application-to-the-U-S--Food-and-Drug-Administration-for-its-COVID-19-Vaccine-08-25-2021/default.aspx
  3. Moderna Announces Preliminary Booster Data and Updates Strategy to Address Omicron Variant. Moderna. December 20, 2021. Accessed January 31, 2022. https://investors.modernatx.com/news/news-details/2021/Moderna-Announces-Preliminary-Booster-Data-and-Updates-Strategy-to-Address-Omicron-Variant/default.aspx