FDA Grants Emergency Use Authorization to Moderna COVID-19 Vaccine

Moderna’s new coronavirus disease 2019 (COVID-19) vaccine, mRNA-1273, has been granted Emergency Use Authorization (EUA) by the FDA,^1,2 only 1 day after the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) publicly expressed support for the action.³ Administration of mRNA-1273 is indicated for individuals aged 18 years and older.²

The FDA's action marks the second EUA for a vaccine targeting COVID-19, which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). On December 11, 2020, the FDA approved an EUA application for the first COVID-19 vaccine in the United States, BNT162b2, which was jointly developed by Pfizer and BioNTech.^1,4

According to FDA Commissioner Stephen M. Hahn, MD, the availability of 2 COVID-19 vaccines is a crucial step in combating the global pandemic, which has caused a vast number of hospitalizations and deaths in the United States.¹

“Through the FDA’s open and transparent scientific review process, 2 COVID-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA. These standards and our review process, which are the same we have used in reviewing the first COVID-19 vaccine and intend to use for any other COVID-19 vaccines, included input from independent scientific and public health experts as well as a thorough analysis of the data by the agency’s career staff,” said Hahn, in a prepared statement.¹

Neither vaccine has been granted FDA approval; however, EUA designation allows these vaccines to be used in addressing a public health emergency. Administration of BNT162b2 began on Monday with the initial wave of recipients.³

Under Operation Warp Speed, the Department of Defense—in partnership with the Department of Health and Human Services and the CDC—will manage allocation and distribution of mRNA-1273 in the United States. Allocation and distribution will be prioritized according to populations identified by the CDC’s Advisory Committee on Immunization Practices.²

According to Moderna, delivery of the mRNA-1273 vaccine to the US government will begin immediately, and it expects to have delivered approximately 20 million doses by the end of December 2020. The company expects to have between 100 million and 125 million doses available globally in the first quarter of 2021, with 85 to 100 million of those available in the United States. The company has also vowed to continue gathering additional data, and Moderna officials said it plans to file a Biologics License Application with the FDA requesting full licensure in 2021.²

Earlier on Friday, Moderna announced that the European Commission (EC) has exercised its option to purchase an additional 80 million doses of mRNA-1273, bringing the EC’s confirmed order commitment to 160 million doses. The doses purchased by the EC will commence from the company’s dedicated European supply chain, according to Moderna.⁵

The FDA’s EUA is based on scientific evidence shared by Moderna, including a data analysis from the pivotal phase 3 COVE clinical study. The primary efficacy analysis conducted on 196 cases in the study indicated a vaccine efficacy rate of 94.1%. The most common solicited adverse reactions (ARs) after the 2-dose series included injection site pain (88.2%), erythema (8.6%), swelling (12.2%), and ipsilateral lymphadenopathy (14.2%). While the majority of these ARs were grade 1 or grade 2, there was a higher occurrence of grade 3 reactions after the second injection. The majority of local solicited ARs occurred within the first 1 to 2 days after injection and generally persisted for a median of 1 to 2 days.²

Stéphane Bancel, CEO of Moderna, thanked company staff, government agencies, and clinical trial participants in a prepared statement. “I am proud of what the Moderna team has achieved in collaboration with our partners. We were able to create and manufacture the Moderna COVID-19 vaccine in 11 months from sequence to authorization, while advancing clinical development with a phase 1, phase 2 and pivotal phase 3 study of 30,000 participants. It has been a 10-year scientific, entrepreneurial, and medical journey, and I am thankful to all those who have helped us get here today. We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease,” said Bancel.²

Safety data continue to accrue, and the study continues to be monitored by an independent Data Safety Monitoring Board appointed by the National Institutes of Health. All participants in the COVE study will continued to be monitored for 2 years for the duration of the study to assess long-term protection and safety.²

REFERENCES

• FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine [news release]. Silver Spring, MD: December 18, 2020: FDA. Accessed December 18, 2020. https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid
• Moderna Announces FDA Authorization of Moderna COVID-19 Vaccine in U.S. [news release]. Cambridge, MA; December 18, 2020. Accessed December 18, 2020. https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-fda-authorization-moderna-covid-19-vaccine-us
• Moderna Receives FDA Advisory Committee Vote Supporting Emergency Use for Moderna’s Vaccine Against COVID-19 in the United States [news release]. Cambridge, MA; December 17, 2020: Moderna. Accessed December 17, 2020. https://investors.modernatx.com/news-releases/news-release-details/moderna-receives-fda-advisory-committee-vote-supporting
• FDA Grants Historic Emergency Use Authorization to COVID-19 Vaccine From Pfizer and BioNTech. Pharmacy Times^®. Published December 12, 2020. Accessed December 17, 2020. https://www.pharmacytimes.com/news/fda-grants-historic-emergency-use-authorization-to-covid-19-vaccine-from-pfizer-and-biontech
• European Commission exercises option for additional 80 million doses of Moderna’s COVID-19 vaccine candidate [news release]. Cambridge, MA; December 18, 2020: Moderna. Accessed December 18, 2020. https://investors.modernatx.com/news-releases/news-release-details/european-commission-exercises-option-additional-80-million-doses