FDA Authorizes Moderna’s COVID-19 Vaccine for Emergency Use

By Patricia Van Arnum - DCAT Editorial Director

December 21, 2020

The US Food and Drug Administration’s (FDA) has authorized the emergency use of Moderna’s vaccine against COVID-19 in individuals 18 years of age or older, making it the second vaccine against COVID-19 authorized for emergency use in the US. On December 11, 2020, Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, received an emergency use authorization from the FDA for their COVID-19 vaccine.

With the authorization by the FDA provided to Moderna on December 18, 2020, delivery to the US government began. Approximately 20 million doses will be delivered to the US government by the end of December 2020, according to the company. Moderna expects to have between 100 million and 125 million doses available globally in the first quarter of 2021 with 85 million to 100 million of those available in the US.

Under Operation Warp Speed, a US initiative to speed the development and distribution of COVID-19 vaccines and treatments, the US Department of Defense, in partnership with the US Department of Health and Human Services (HHS) and the US Centers for Disease Control and Prevention (CDC), will manage allocation and distribution of the vaccine in the US. Allocation and distribution will be prioritized according to populations identified by the CDC’s Advisory Committee on Immunization Practices (ACIP), which recommended the use of the vaccine in people 18 years of age and older. 

Moderna says it will continue to gather additional data and plans to file a biologics license application with the FDA requesting full licensure in 2021. The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the HHS, is supporting the continued research and development of the vaccine with $955 million in federal funding. BARDA is reimbursing Moderna for 100% of the allowable costs incurred by the company for conducting the program described in the BARDA contract.

EU exercises its option for additional supply of the vaccine

Separately, the European Commission has exercised its option to purchase an additional 80 million doses of Moderna’s COVID-19 vaccine to bring its confirmed order commitment to 160 million doses. The first deliveries to European countries from Modena’s dedicated European supply chain are expected to commence early in 2021 following regulatory approval by the European Medicines Agency (EMA). These deliveries are subject to receipt of the positive opinion from the EMA’s scientific committee for human medicines (CHMP) and the European Commission’s decision regarding the conditional marketing authorization for the vaccine. The CHMP meeting is planned for January 6, 2021.

Totals in all supply agreements

In total, Moderna has confirmed (as of December 18, 2020), the following supply agreements of committed orders totaling more than 390 million doses: (1) US: 200 million doses with an option for an additional 300 million doses; (2) European Union: 160 million doses; (3) Japan: 50 million doses; (4) Canada: 40 million doses with an option for an additional 16 million doses; (5) Switzerland: 7.5 million doses; (6) the UK: 7 million doses; (7) Israel: 6 million doses; (8) Qatar, undisclosed amount; (9) Singapore, undisclosed amount; and (10) other countries, which have placed orders and have not been disclosed.

Source: Moderna (emergency use authorization), FDA (emergency use authorization), Moderna (CDC recommendation), Moderna (EU supply).