FDA advisory committee votes to recommend emergency use of Moderna COVID-19 vaccine
WASHINGTON - A key advisory committee to the U.S. Food and Drug Administration on Thursday voted to recommend the approval of Moderna’s COVID-19 vaccine for emergency use, one of the final hurdles before a second shot could be approved by the agency for emergency use and distributed across 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 reviewed available data during an all-day meeting where votes were cast at approximately 5 p.m. ET.
The FDA’s Dr. Doran Fink opened the daylong meeting reiterating that the agency’s review would be "transparent, scientifically sound and data-driven."
Moderna’s vaccine is largely following the same path as Pfizer-BioNTech’s, which relies on the same groundbreaking technology. Most traditional vaccines use dead or weakened virus, but both of the new vaccines use snippets of COVID-19’s genetic code to train the immune system to detect and fight the virus. Both require two doses, weeks apart.
The thumbs-up by the panel comes ahead of a decision by the FDA on the authorization of emergency use of the vaccine. The FDA is expected to give the green light within hours or days — which is needed before the vaccine can officially be distributed to the masses.
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.
The rapid development of two highly effective vaccines using the novel technique is one of the scientific triumphs in the race against coronavirus.
"This is coming much faster than what anybody thought," said Dr. Jesse Goodman, of Georgetown University, former chief of the FDA’s vaccine division. "Something that might have otherwise taken several years -- to take this new vaccine technology and test it and approve it -- was compressed into within a year."
But he added both vaccines have only been studied in volunteers for a few months and more follow-up is needed to answer important questions, such as how long protection lasts.
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Another unanswered question is whether the vaccine also prevents people from symptomless infection – but Moderna found a hint that it may. Study participants had their noses swabbed before a second dose of either vaccine or placebo. At that one timepoint, tests from 14 vaccine recipients and 38 placebo recipients showed evidence of asymptomatic infection, said Moderna’s Dr. Jacqueline Miller.
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.
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.
This story was reported from Cincinnati. The Associated Press contributed.