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WASHINGTON - A key advisory committee to the U.S. Food and Drug Administration on Thursday is set to vote on whether to recommend the approval of Moderna’s COVID-19 vaccine, one of the final hurdles before a second shot could be distributed in the United States.
The two-dose vaccine, from Moderna and the National Institutes of Health, was found to be more than 94% effective in preventing COVID-19 for individuals 18 and older. Earlier this week, the FDA released a preliminary analysis confirming the shot’s effectiveness and safety.
The independent panel of outside experts will next review the data available during an all-day meeting. It’s scheduled to begin at 9 a.m. ET to 5:15 p.m. ET, according to an agenda — with discussion and a vote planned for the afternoon.
A final FDA decision is expected soon thereafter, which is needed before the vaccine can be officially distributed to the masses.
A file image shows medical syringes in front of the Moderna pharmaceutical logo on Dec. 14, 2020. (Photo by Nicolas Economou/NurPhoto via Getty Images)
A week ago, the committee recommended the vaccine developed by Pfizer and BioNTech. After it was given emergency use authorization by the FDA, shipments to the nation’s hospitals quickly began.
The first 3 million shots are being strictly rationed to front-line health workers and elder-care patients, with hundreds of millions more shots needed over the coming months to protect most Americans.
A second vaccine can’t come soon enough as the country’s death toll has surpassed a staggering 307,000 deaths, according to COVID-19 data compiled by Johns Hopkins University. The devastating toll is only expected to grow in coming weeks, fueled by holiday travel, family gatherings and lax adherence to public health measures meant to curb the spread of the virus.
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Dr. Chin-Hong explains how COVID-19 vaccines differ from traditional vaccines.
Moderna requested emergency use authorization from the FDA on Nov. 30. Its Phase 3 trial, which began in late July, consisted of 30,000 volunteers — half of whom received a placebo.
The most common side effects were injection site pain, fatigue, headache, joint pain, muscle aches and redness at the injection site, according to a news release. The second dose produced the most frequent adverse reactions, Moderna said.
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This story was reported from Cincinnati. The Associated Press contributed.