The FDA has signalled it will approve the Moderna vaccine. By Press Association Friday 18 Dec 2020, 7:26 AM Dec 18th 2020, 7:26 AM 7,384 Views 9 Comments
Image: Shutterstock/89stocker
Image: Shutterstock/89stocker
THE HEAD OF the US Food and Drug Administration (FDA) has said the agency will move to quickly authorise Moderna’s Covid-19 vaccine.
Stephen Hahn’s announcement came just hours after the vaccine won the endorsement of a government advisory panel.
The FDA commissioner said in a statement that regulators have communicated their plans to the pharmaceutical company, which co-developed the vaccine with the National Institutes of Health.
The announcement came after a panel of FDA advisers, in a 20-0 vote, ruled that the benefits of the vaccine outweighed the risks for those 18-years-old and up.
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A second COVID-19 vaccine moved closer to joining the US fight against the pandemic on Thursday as government experts convened for a final public review of its safety and effectiveness.
The head of the Food and Drug Administration said late Thursday that his agency will move to quickly authorize the second COVID-19 vaccine to fight the pandemic, hours after the shot won the key endorsement of a government advisory panel.
FDA Commissioner Stephen Hahn said in a statement that regulators have communicated their plans to drugmaker Moderna, which co-developed the vaccine with the National Institutes of Health. The announcement came after a panel of FDA advisers, in a 20-0 vote, ruled that the benefits of the vaccine outweighed the risks for those 18 years old and up.
Ashlee Rezin Garcia/Sun-Times
WASHINGTON A government advisory panel endorsed a second COVID-19 vaccine Thursday, paving the way for the shot to be added to the U.S. vaccination campaign.
The Food and Drug Administration is expected to follow the recommendation and quickly OK the vaccine from Moderna and the National Institutes of Health. The FDA advisers, in a 20-0 vote, agreed the benefits of the vaccine outweighed the risks for those 18 years old and up.
Once emergency use authorization is granted, Moderna will begin shipping millions of doses, earmarked for health workers and nursing home residents, to boost the largest vaccination effort in U.S. history.
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FDA authorizes Moderna COVID-19 vaccine for emergency use
By Matthew Perrone and Lauran Neergaard
Published
FDA advisory committee votes to recommend emergency use of Moderna COVID-19 vaccine
A key advisory committee to the FDA on Thursday voted to recommend the approval of Moderna’s COVID-19 vaccine for emergency use, one of the final hurdles before FDA authorization.
WASHINGTON - The U.S. Food and Drug Administration authorized Moderna’s coronavirus vaccine for emergency use on Friday, the second vaccine to be approved by U.S. regulators to prevent severe COVID-19 illness.
FDA Commissioner Stephen M. Hahn, called the approval another crucial step in the fight against this global pandemic.