FDA Panel Recommends Moderna’s COVID-19 Vaccine For Emergency Use
Updated at 5:04 p.m. with results of the vote.
In a 20-0 vote, with 1 abstention, a panel of advisers to the Food and Drug Administration recommended that the COVID-19 vaccine being developed by Moderna be authorized for emergency use in adults during the pandemic.
The vote in favor of the vaccine was taken to answer the agency’s question: Do the benefits of the Moderna vaccine outweigh its risks for use in people 18 years of age and older.
The agency typically follows the advice of its expert advisers.
A quick FDA decision is expected given the state of the pandemic, of 94% effectiveness of the Moderna vaccine in preventing COVID-19 and a determination by the FDA that there are no specific safety concerns that would stand in the way. The FDA authorized the Pfizer-BioNTech COVID-19 vaccine last Friday, a day after the same panel voted in favor of it.
The original story continues.
The same group of advisers to the Food and Drug Administration that voted to recommend the Pfizer-BioNTech COVID-19 vaccine for emergency use a week ago convenes again today to consider the Moderna vaccine.
The agency frequently seeks advice from these committees of independent experts when considering whether to make available a new drug or vaccine. In this case, the agency will ask the committee to vote on whether the evidence shows that the benefits of the Moderna vaccine outweigh its risks.
On Tuesday, the FDA released its analysis of the vaccine, along with an information packet from Moderna. The agency found the vaccine to be 94% effective and to have a “favorable safety profile” that raises “no specific safety concerns identified that would preclude issuance of an EUA,” or emergency use authorization.
Some side effects were very common in the main clinical trial of the Moderna vaccine, which included more than 30,000 people, half of whom received two shots of vaccine and half of whom received two shots of placebo a month apart. Most everyone experienced pain at the injection site — 92%. Other common reactions included fatigue (69%), headache (63%) and muscle pain (60%).
Serious adverse reactions were uncommon. There were three reports of a facial paralysis called Bell’s palsy in the vaccine group and one in the placebo group. The FDA said there wasn’t enough information to determine if the vaccine caused the cases.
One goal of the public meeting is to provide transparency about the evidence for the vaccine. Another is to build confidence in the process.
The documents and testimony from agency and company officials will inform the discussion, which will culminate in a vote late Thursday afternoon.
The FDA analysis supports a case that the Moderna vaccine should be authorized for emergency use, a quicker approach than the standard for full licensure.
During the panel meeting about the Pfizer vaccine, the main sticking point was whether the evidence for use of the vaccine in 16- and 17-year-olds was sufficient to include them in the population to get the vaccine. The vote 17-4, with one abstention, to recommend an EUA including those people reflected some doubts among a few of the experts that the evidence was adequate. Still, the solid majority vote paved the way for the agency to OK the vaccine, including for use in older adolescents.
Authorization of Moderna’s vaccine will be considered only for adults, so the meeting may go more smoothly.
The agency acted the day after the panel meeting for Pfizer’s vaccine. FDA granted it emergency use authorization late last Friday night, making it the first COVID-19 to be mobilized in the fight against the disease in the U.S.
Moderna’s vaccine could become the second.
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