CNBC's Meg Tirrell reports on the FDA's approval recommendation for Moderna's vaccine for emergency use. With CNBC's Melissa Lee and the Fast Money traders, Guy Adami, Tim Seymour, Karen Finerman and Dan Nathan. For access to live and exclusive video from CNBC subscribe to CNBC PRO: [ Ссылка ]
An influential Food and Drug Administration advisory panel on Thursday overwhelmingly backed Moderna’s coronavirus vaccine, a key step paving the way to distribute the second Covid-19 vaccine in the United States next week.
The nonbinding decision, which was adopted 20-0 with one abstention, by the FDA’s Vaccines and Related Biological Products Advisory Committee came exactly a week after the outside group of vaccine and infectious disease experts voted to recommend Pfizer and BioNTech’s vaccine for an emergency use authorization, or EUA. The agency granted Pfizer’s EUA the next day, and the first inoculations in the U.S. were given Monday.
The FDA advisory committee plays a key role in approving flu and other vaccines in the U.S., verifying the shots are safe for public use. While the FDA doesn’t have to follow the advisory committee’s recommendation, it often does. The U.S. plans to ship just under 6 million doses next week, pending the agency’s OK, Gen. Gustave Perna, who oversees logistics for the Operation Warp Speed vaccine project, told reporters Monday.
Prior to the vote, some members of the committee stressed that their endorsement for Moderna’s vaccine was not for a full FDA approval, reiterating that the agency will still need to review more data on safety and effectiveness.
“I don’t want people to interpret this the same way they would a licensed vaccine,” said Dr. Cody Meissner, a voting member of the committee and an infectious diseases expert at Tufts University School of Medicine. The endorsement is “based on the available evidence, but that’s limited.”
An EUA means the FDA will allow some people to receive the vaccine as the agency continues to evaluate data. It isn’t the same as full approval, which requires more data and can typically take several months longer. Moderna has submitted only two months of follow-up safety data. The agency usually requires six months for full approval. The committee recommended emergency authorization of the vaccine for people who are 18 years old and older.
Member Dr. Michael Kurilla, an infectious diseases expert with the National Institutes of Health, was the only member to not vote yes. He said he decided to abstain because he was “uncomfortable” endorsing the vaccine for everyone age 18 and older.
“In the midst of a pandemic and with limited vaccine supply, a blanket statement for individuals for 18 years and older is just too broad,” said Kurilla. “I’m not convinced for all of those age groups the benefits do actually outweigh the risk.”
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