CAMBRIDGE, Mass. — A Cambridge company is on the brink of history.
Moderna’s coronavirus vaccine has been recommended for use by independent experts and could be cleared for use in the U.S. Friday.
Right now there are millions of doses of Moderna’s vaccine ready and waiting to be shipped across the United States. All that is needed is formal approval from the FDA & CDC. That could come quickly because independent experts on an FDA advisory panel recommended the vaccine be approved Thursday in an almost unanimous vote.
One person did abstain but everyone else voted yes. One of the 20 favorable votes came from Dr. Eric Rubin of the New England Journal of Medicine.
Wale: “Why did you vote yes?”
Dr. Rubin: “Their data are really impressive. This vaccine and the other vaccine we considered last week work almost 95% of the time to prevent disease. The side effects so far, it’s not a large number group of people, it’s not a long time, but the side effects so far look very manageable.”
Side effects, its efficacy, and how to deal with distrust especially amongst groups of color were the discussions that filled up eight hours between the panel, members of the public, and presenters.
“There is an increase in grade three reactions after the second injection and the mRNA groups,” said David Martin, MD, MPH, of Moderna. “Again the grade for reactions occurred at very low rates. Overall most reactions were still mild to moderate resolved within one to two days.”
“There have been reports of a reaction occurring in the U.K. and also in Alaska,” said Dr. Ruben, an infectious disease doctor & microbiologist. “It’s something to at least pay close attention to.”
The FDA & CDC are expected to also pay close attention to this panel’s endorsement that the benefits of the vaccine outweighed the risks for those 18 years old and up. If so, the combination of Moderna and Pfizer-BioNTech vaccine, government officials confident that 20 million Americans will be able to have their first shots by the end of the year.
“You had a room full of experts,” said Dr. Ruben. “None of them would have any connection with the company, none of whom make money off of this and all of whom were really quite convinced that this vaccine is the way to go and my guess is that almost all of them are going to be standing in line to get the vaccine themselves and get it for their families.”
Moderna is just starting to study its vaccine in children ages 12 to 17. Testing in younger children is expected to start early next year.
Health experts said in the meeting that, either way, we should all be impressed. One year ago, we knew nothing about this virus and now we have two potential vaccines. As far as which vaccine people should choose to get, doctors say based on the data, they’re pretty indistinguishable so take whatever you can get your hands on. It’s just important to make sure that the second dose is with the same vaccine as the first dose.
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