Posted on Jun 8, 2022
Advisers to the FDA back Novavax COVID vaccine
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https://www.npr.org/sections/health-shots/2022/06/07/ [login to see] /advisers-to-the-fda-back-novavax-covid-vaccine
In a 21-0 vote with one abstention, advisers to the Food and Drug Administration recommended that the agency authorize Novavax's two-dose vaccine against COVID-19.
In comments to the committee before its vote, Dr. Peter Marks, the FDA's top vaccine official said, "We speak to making available another option for those who might not otherwise take a vaccine."
During the panel's deliberations, Dr. Eric Rubin, editor in chief of The New England Journal of Medicine, said that data for the Novavax vaccine look a lot like those for the mRNA vaccines made by Moderna and Pfizer-BioNTech.
By the same regulatory criteria, he said, "it's not that difficult a decision now" to recommend authorization. Nonetheless, he said he was disappointed that there wasn't more data about how the Novavax vaccine performed against current variants of the coronavirus. "We're looking at efficacy against strains that don't exist any longer," he said.
In a 21-0 vote with one abstention, advisers to the Food and Drug Administration recommended that the agency authorize Novavax's two-dose vaccine against COVID-19.
In comments to the committee before its vote, Dr. Peter Marks, the FDA's top vaccine official said, "We speak to making available another option for those who might not otherwise take a vaccine."
During the panel's deliberations, Dr. Eric Rubin, editor in chief of The New England Journal of Medicine, said that data for the Novavax vaccine look a lot like those for the mRNA vaccines made by Moderna and Pfizer-BioNTech.
By the same regulatory criteria, he said, "it's not that difficult a decision now" to recommend authorization. Nonetheless, he said he was disappointed that there wasn't more data about how the Novavax vaccine performed against current variants of the coronavirus. "We're looking at efficacy against strains that don't exist any longer," he said.
Advisers to the FDA back Novavax COVID vaccine
Posted from npr.org
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Posted 2 y ago
Responses: 2
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PO1 William "Chip" Nagel
..."The Novavax vaccine uses copies of the SARS-CoV-2 spike protein produced in a factory rather than snippets of genetic code to instruct the body's cells to make the protein that prompts an immune response. Both approaches have proved succesful against COVID-19.
There is some evidence the Novavax vaccine may cause a rare swelling of the heart that also occurs sometimes in people who get one of the other COVID-19 vaccines. The problem has also been seen with mRNA vaccines. But the committee concluded that the benefits of the Novavax vaccine outweigh the risks.
The FDA typically follows the recommendations of its advisers but isn't bound to do so.
If the agency authorizes the Novavax vaccine, the final step before it could be rolled out would be an endorsement by the Centers for Disease Control and Prevention."
..."The Novavax vaccine uses copies of the SARS-CoV-2 spike protein produced in a factory rather than snippets of genetic code to instruct the body's cells to make the protein that prompts an immune response. Both approaches have proved succesful against COVID-19.
There is some evidence the Novavax vaccine may cause a rare swelling of the heart that also occurs sometimes in people who get one of the other COVID-19 vaccines. The problem has also been seen with mRNA vaccines. But the committee concluded that the benefits of the Novavax vaccine outweigh the risks.
The FDA typically follows the recommendations of its advisers but isn't bound to do so.
If the agency authorizes the Novavax vaccine, the final step before it could be rolled out would be an endorsement by the Centers for Disease Control and Prevention."
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