FDA authorizes Moderna's COVID-19 vaccine for emergency use
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The Food and Drug Administration has issued an emergency use authorization (EUA) for Moderna's COVID-19 vaccine, one day after it was endorsed by a panel of independent experts.
Why it matters: The authorization of a second coronavirus vaccine, coming exactly one week after the FDA cleared Pfizer-BioNTech's vaccine for emergency use, increases vaccine access for millions of Americans and marks another milestone on the country’s path to curbing the pandemic.
Between the lines: Moderna's vaccine, which the FDA confirmed is safe and has a 94.1% efficacy rate, does not need to be stored at ultracold temperatures and comes in smaller batches, making it easier to distribute to rural areas than Pfizer's vaccine.
What they're saying: "To have two vaccines against a novel virus authorized and distributed within a year is extraordinary, and to have one of these vaccines developed by scientists at the NIH should be a great source of pride for every member of the HHS family and every American," HHS Secretary Alex Azar said in response to the FDA's authorization.
- "The DoD, with the work of General Perna and Operation Warp Speed, stands ready to work with our public and private-sector partners to ensure doses reach Americans as soon as possible," Acting Secretary of Defense Christopher Miller said.
What's next: The FDA's decision means that the distribution of roughly 6 million doses of Moderna's vaccine will begin this weekend.
- The Centers for Disease Control has advised that frontline workers and nursing home patients be the first recipients of available vaccines. Thousands began receiving the first doses of Pfizer's vaccine last week.
- A CDC committee will decide on Sunday which "priority group" should come next, with "essential workers" like teachers and law enforcement likely to be recommended, according to the New York Times.
- Governors will then be responsible for determining which people within that group will receive their state's limited supply of vaccines.
The big picture: The authorization of Moderna's vaccine comes one day after a record 3,438 Americans were reported to have died from the virus. It also comes amid confusion and concern after the Trump administration informed state after state that they'll be getting 25%-40% fewer Pfizer vaccine doses next week than they'd been expecting.
What to watch: Operation Warp Speed officials said Johnson & Johnson closed recruitment for its Phase 3 trials — which have enlisted about 44,000 people — on Thursday.
- The company is expecting results on its one-dose vaccine candidate by early January.
