Moderna’s coronavirus vaccine on its way to states after FDA grants approval
By
Alicia Lasek
Dec 21, 2020
The FDA announced its approval late Friday, and roughly six million doses of the COVID-19 drug began shipping from warehouses two days later, officials said.
FDA approves first fully at-home COVID-19 test
By
Alicia Lasek
Dec 17, 2020
Results are available in about 20 minutes via a mobile phone app, and the test is more than 90% accurate in both symptomatic and asymptomatic individuals, the agency announced Tuesday.
Moderna’s vaccine highly effective against COVID-19: FDA review
By
John O'Connor
Dec 16, 2020
Moderna’s COVID-19 vaccine is 94% effective in preventing symptomatic illness, according to information released Tuesday. The initial review’s findings appear to set the table for federal authorization...
Monitor vaccinated residents for signs of Bell’s palsy, feds warn
By
John O'Connor
Dec 16, 2020
Long-term care residents will be among the first people in the nation to receive COVID-19 vaccinations. On Tuesday, Food and Drug Administration staff recommended that they be checked for possible cases...
First doses of federally approved COVID-19 vaccine en route to nursing homes
By
Danielle Brown
Dec 14, 2020
Nursing home residents and workers may start receiving the first doses of Pfizer-BionNTech’s COVID-19 vaccine as early as today after the vaccine gained key federal approvals over the weekend.
FDA panel recommends emergency use for Pfizer COVID vaccine
By
Danielle Brown
Alicia Lasek
Dec 11, 2020
“I think we know enough now to say this [vaccine] appears to be our way out of this awful, awful mess,” one committee member told CNN after the Thursday vote. The vaccine is highly effective, with...
As FDA panel endorses Pfizer vaccine, CVS Health says it’s ready to administer doses in nursing...
By
Danielle Brown
Dec 11, 2020
CVS Health’s top executive is confident that the company will be administering coronavirus vaccines in “thousands” of long-term care facilities before the Christmas holiday pending federal approval.
‘Most dangerous’ pandemic months ahead, former FDA leader tells providers
By
Danielle Brown
Nov 18, 2020
A former leader of the Food and Drug Administration is warning long-term care providers to stay vigilant and proactive as they head into the “seventh inning” of the coronavirus public health crisis.
FDA advisers vote ‘no’ on drug that may slow Alzheimer’s progression
By
Alicia Lasek
Nov 09, 2020
If approved by the FDA, aducanumab would be the first-ever drug marketed to slow progression of the brain-wasting disease, according to its developer. But an advisory committee was unconvinced of the drug’s...
Expect false positives: FDA letter to providers explains COVID antigen test results
By
Alicia Lasek
Nov 05, 2020
The agency clarifies that rapid antigen tests, “like all diagnostic tests,” are subject to false positive results, especially in low prevalence settings. It offers recommendations for administering...