A week after Pfizer Inc. PFE received the greenlight for its vaccine against the coronavirus, the Food and Drug Administration cleared a similar vaccine candidate, mRNA-1273, from Moderna Inc MRNA.
What Happened: The FDA authorized the emergency use of mRNA-1273 against COVID-19 in individuals 18 years and older, the Cambridge, Massachusetts-based biopharma said in a late Friday statement.
It is the second vaccine candidate approved conditionally in the U.S. It belongs to the new class of vaccines called messenger RNA vaccines. It contain a small piece of the SARS-CoV-2 virus' mRNA that instructs cells in the body to make the virus' distinctive "spike" protein. Once vaccinated, the body produces copies of the spike protein, which does not cause disease but triggers the immune system to react defensively, producing an immune response against SARS-CoV-2.
The decision was in line with expectations following a positive FDA committee review that favored approval by a vote of 20-0, with one abstention.
Deliveries to the U.S. government will begin immediately, the company said.
"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," said Stéphane Bancel, CEO of Moderna, in a statement.
FDA Commissioner Stephen Hahn said, "With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day."
The Logistics and Distribution: Given Moderna's vaccine was covered under the U.S. government's Operation Warp Speed, the Department of Defense, along with the Department of Health and Human Services and the U.S. Centers for Disease Control and Prevention, will manage allocation and distribution of the vaccine in the U.S.
Prioritization will be determined by the CDC's Advisory Committee on Immunization Practices, Moderna said.
The company expects to deliver 20 million doses to the U.S. government by the end of the month, and have another 100 million to 125 million doses available globally by in the first quarter of 2021. About 85 million to 100 million doses of the first-quarter availability will be supplied to the U.S. government, it added.
What's Next: Moderna said it will continue to gather additional data and look ahead to file a biologics license application with the FDA, requesting full licensure in 2021.
Moderna's shares, which ended Friday's session down 2.62% at $140.23, advanced 2.24% to $143.37 in the after-hours session. The stock has run up about 620% year-to-date.
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