Moderna Completes FDA Submission for Full Approval of COVID-19 Vaccine

Moderna has announced completion of the Biologics License Application (BLA) rolling submission process for its messenger RNA (mRNA) COVID-19 vaccine, according to a company press release.¹

Moderna has applied for full licensure of its vaccine for active immunization to prevent COVID-19 in individuals 18 years of age and older and has requested Priority Review designation. The Fast Track designation granted in May 2020 has allowed the company to submit sections of the BLA on a rolling basis and the BLA submission was initiated on June 1, 2021.¹

“This BLA submission for our COVID-19 vaccine, which we began in June, is an important milestone in our battle against COVID-19 and for Moderna, as this is the first BLA submission in our company’s history,” said Stephane Bancel, chief executive officer of Moderna, in the press release. “We are pleased that our COVID-19 vaccine is showing durable efficacy of 93% through 6 months after dose 2.”¹

The completed submission includes clinical data from the phase 3 COVE study, which enrolled more than 30,000 participants in the United States. In a final analysis of the study data, the vaccine’s 93% efficacy remained durable through 6 months after administration of the second dose.¹ Reported adverse reactions included pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea or vomiting, axillary swelling or tenderness, swelling at the injection site, and erythema at the injection site.¹

The vaccine is currently available under Emergency Use Authorization (EUA) for individuals 18 years of age and older, and more than 300 million doses have been released to the US government since its EUA was granted on December 18, 2020. Moderna has also filed for an EUA for adolescents 12 years of age and older.¹

In addition, the FDA recently authorized a third dose of the vaccine for immunocompromised individuals 18 years of age and older who have undergone solid organ transplantation or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. A recent trial of 120 individuals who had undergone solid organ transplant procedures demonstrated that a third dose improved immune response compared to placebo, according to a press release.²

“We recognize the need to protect immunocompromised individuals who are at the highest risk of severe COVID-19 disease,” Bancel said in the press release. “It is promising to see recent studies demonstrating that a third dose of the Moderna COVID-19 vaccine may enhance immune response in immunocompromised populations. We will continue to generate data on protection against SARS-CoV-2 variants and we remain committed to helping to end the COVID-19 pandemic with our mRNA vaccine.”²

Data have also shown that the vaccine generates neutralizing antibodies against variants of concern, including Alpha, Beta, Gamma, Delta, Epsilon, and Iota. According to a paper published in Science, the majority of individuals vaccinated with Moderna’s vaccine maintained both binding and functional antibodies against SARS-CoV-2 variants for 6 months following the second dose.³

“These data support the durable efficacy of 93% seen with the Moderna COVID-19 vaccine through 6 months,” Bancel said in the press release announcing these data. “We expect that these data and the growing body of real-world evidence will help inform health regulators’ approaches to how and when to administer additional boosting doses.”³

REFERENCE

1. Moderna Completes Submission of Biologics License Application to the US Food and Drug Administration for its COVID-19 Vaccine. News release. Moderna; August 25, 2021. Accessed August 25, 2021. https://investors.modernatx.com/news-releases/news-release-details/moderna-completes-submission-biologics-license-application-us

2. Moderna Announces FDA Authorization of Third Dose of COVID-19 Vaccine for Immunocompromised Individuals. News release. Moderna; August 13, 2021. Accessed August 25, 2021. https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-fda-authorization-third-dose-covid-19-vaccine

3. Moderna Announces New Study Showing Its COVID-19 Vaccine Maintains Antibodies Against Variants of Concern and Interest to 6 Months. Moderna; August 12, 2021. Accessed August 25, 2021. https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-new-study-showing-its-covid-19-vaccine