Under the terms of the proposed agreement, the company will commence distribution of the vaccine in the second quarter of 2021.
The Moderna COVID-19 vaccine has not been approved or licensed by the US Food and Drug Administration (FDA) or any other health authority.
However, the vaccine has been authorised by the US FDA for emergency use in individuals 18 years of age and older.
Moderna’s mRNA-1273 is said to be the second Covid-19 vaccine candidate after Pfizer and BioNTech’s mRNA vaccine BNT162b2 to have been granted the emergency use authorisation by the FDA.
Recently, Moderna has been authorised by Health Canada for its vaccine against Covid-19 for the immunisation of people 18 years of age and older under an Interim Order.
In a press statement, Moderna said: “The authorization comes under Health Canada’s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 and is based on a rolling review of data that was announced on October 12, 2020. The rolling review includes data from the Phase 3 COVE study involving 30,000 participants.”
Moderna is planning to continue to gather additional data and plans to file a Biologics License Application (BLA) with the US FDA and seeks to secure full licensure in 2021.
Under Operation Warp Speed, the US Department of Defense (DoD) will work with US Department of Health and Human Services (HHS) and US Centers for Disease Control and Prevention (CDC) to manage allocation and distribution of the vaccine in the US.
The company plans to deliver approximately 20 million doses to the US government by the end of December 2020.
In the first quarter of 2021, the firm intends to deliver between 100 million and 125 million doses globally, including 85-100 million of dosed planned to be made available in the US.