FDA review confirms effectiveness, safety of Moderna vaccine, clearing way for emergency authorization
By MATTHEW PERRONE The Associated Press,Updated December 15, 2020, 8:14 a.m.
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A bicyclist stops to check his phone in front of Moderna in Cambridge. Moderna said Monday that its experimental COVID-19 vaccine was nearly 95 percent effective at preventing infections, in the first glimpse of data from its late-stage clinical trial.Jessica Rinaldi/Globe Staff
WASHINGTON (AP) â Hundreds more U.S. hospitals are set to begin vaccinating their workers Tuesday as federal regulators issued a positive review of a second COVID-19 vaccine shot needed to boost the nationâs largest vaccination campaign.
In Florida, government officials expect to have 100,000 doses of the vaccine by Tuesday at five hospitals across the state. This is 20,000 doses of hope, said John Couris, president and chief executive officer, Tampa General Hospital, after the delivery of 3900 vaccine vials on Monday. Each vial has five doses.
Because the vaccine requires two rounds, the people getting injections now will need a second shot in about three weeks.
In this July 27, 2020, file photo, nurse Kathe Olmstead prepares a shot that is part of a possible COVID-19 vaccine, developed by the National Institutes of Health and Moderna Inc. Moderna said on November 16, 2020, its COVID-19 shot provides strong protection against the coronavirus surging around the world. (AP)
Colleen Teevan, System Pharmacy Clinical Manager at Hartford HealthCare, administers the Pfizer-BioNTech vaccine for COVID-19 to healthcare worker Connor Paleski outside of Hartford Hospital, Monday, Dec. 14, 2020, in Hartford, Conn. (AP Photo/Jessica Hill) Photo: Associated Press
By MATTHEW PERRONE and LAURAN NEERGAARD AP Health Writer
WASHINGTON (AP) Hundreds more U.S. hospitals geared up to vaccinate their workers Tuesday as federal regulators issued a positive review of a second COVID-19 vaccine that’s likely to soon boost the nation’s largest vaccination campaign.
The Food and Drug Administration said its preliminary analysis confirmed the effectiveness and safety of the vaccine developed by Moderna and the National Institutes of Health, bringing it to the cusp of U.S. authorization.
Moderna COVID-19 vaccine shows no specific safety concerns, FDA says
Updated on: December 15, 2020 / 10:42 AM / CBS/AP FDA clears way for second COVID-19 vaccine
The Food and Drug Administration on Tuesday issued an encouraging briefing document about the Moderna COVID-19 vaccine ahead of a meeting by experts on whether to grant it emergency approval.
The FDA was upbeat on the vaccine, saying there were no specific safety concerns identified that would preclude issuance of an EUA (Emergency Use Authorization) and confirmed an overall efficacy of 94.1%.
A panel of outside experts will offer their recommendation on the Moderna vaccine on Thursday, with a final FDA decision expected soon thereafter. If the FDA gives the green light, the first shipments could start rolling out across the country next week.
FDA confirms effectiveness, safety of Moderna vaccine
Hundreds more U.S. hospitals are gearing up to vaccinate their workers as federal health officials posted a positive review of a second COVID-19 shot.
By MATTHEW PERRONE and LAURAN NEERGAARDAP Health Writer
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WASHINGTON Hundreds more U.S. hospitals geared up to vaccinate their workers Tuesday as federal regulators issued a positive review of a second COVID-19 vaccine needed to boost the nation’s largest vaccination campaign.
The Food and Drug Administration said its preliminary analysis confirmed the effectiveness and safety of the vaccine developed by Moderna and the National Institutes of Health, bringing it to the cusp of U.S. authorization.