Moderna's COVID Vaccine — Which Seems to Prevent Severe Cases — Is Up for Emergency FDA Approval
Moderna Inc. is taking the next step to distribute its experimental coronavirus vaccine.
In a statement on Monday, the biotech company said it intends to request approval from the Food and Drug Administration (FDA) for their COVID-19 vaccine, which Moderna says is 94 percent effective at preventing the virus and 100 percent effective at preventing severe COVID-19 cases.
Moderna said that a meeting with the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) to review the safety of the vaccine will likely take place on Dec. 17.
"This is striking," Dr. Paul Offit, a member of the FDA's vaccine advisory committee, told CNN. "These are amazing data."
Moderna is the second company to seek approval from the FDA after Pfizer, whose coronavirus vaccine is at least 95 percent effective.
Earlier this month, Moderna announced the promising results of its vaccine trial. The trial, known as the COVE study, included 30,000 participants, with half getting the vaccine and the other given a placebo.
The participants were instructed to live their lives as usual, and 90 of those with the placebo contracted COVID-19 during that time, 11 of which were severe cases. Of the vaccine group, just five got COVID-19, and none of their cases were severe.
That data showed a 94.5 percent effectiveness for the vaccine.
Moderna, part of the U.S. government's Operation Warp Speed program, also said the COVE study did not show any "significant safety concerns" and that the vaccine was generally well-tolerated.
“This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” Moderna CEO Stéphane Bancel said in a statement.
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Meanwhile, Pfizer has already submitted requests for emergency approval from the FDA.
Pfizer, along with their German partner BioNTech, said they could have 50 million doses available this year, and 1.3 billion in 2021.
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