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Related: Editorials & Other Articles, Issue Forums, Alliance Forums, Region ForumsModerna Pulls Promising Covid-Flu Combo Shot as RFK Continues Antivax Campaign
Moderna had designs on releasing a combined influenza and covid-19 vaccine after some promising trials, but this week the drugmaker said it would withdraw its application seeking approval from the U.S. Food and Drug Administration for the time being, according to a report from Reutersthe latest indication that Department of Health and Human Services Secretary Robert F. Kennedy Jr.s vaccine skepticism has fully infected the federal government.
Moderna isnt giving up on the combo shot entirelyit plans to resubmit later this year after it collects more data from its Phase III trials, which test how well a new treatment works compared to existing options. But the early indicators out of its trials have been positive, with recipients of the dual vaccine generating the same or greater immune response compared to those given separate vaccines. But for the time being, the company is pulling back and doesnt anticipate approval being granted until at least 2026.
The companys decision to pump the brakes comes just one day after the FDA announced that it will require new clinical trials to be conducted before any of the annual covid-19 boosters receive approval for healthy Americans under the age of 65. The agency will require boosters to go through a randomized, controlled trial before getting approvala process that vaccine makers warned would likely delay the availability of the shots well beyond the point in which they would be useful to address the currently circulating strain of covid-19 that they were designed to address.
This new restriction has already had an impact. Novavaxs covid-19 vaccine shot received approval last week, more than a month later than the initial deadline for approval, but the FDA limited access to people over the age of 65 and people between the ages of 12 and 64 who have at least one underlying condition that puts them at risk of severe illness from a covid-19 infection.
Moderna isnt giving up on the combo shot entirelyit plans to resubmit later this year after it collects more data from its Phase III trials, which test how well a new treatment works compared to existing options. But the early indicators out of its trials have been positive, with recipients of the dual vaccine generating the same or greater immune response compared to those given separate vaccines. But for the time being, the company is pulling back and doesnt anticipate approval being granted until at least 2026.
The companys decision to pump the brakes comes just one day after the FDA announced that it will require new clinical trials to be conducted before any of the annual covid-19 boosters receive approval for healthy Americans under the age of 65. The agency will require boosters to go through a randomized, controlled trial before getting approvala process that vaccine makers warned would likely delay the availability of the shots well beyond the point in which they would be useful to address the currently circulating strain of covid-19 that they were designed to address.
This new restriction has already had an impact. Novavaxs covid-19 vaccine shot received approval last week, more than a month later than the initial deadline for approval, but the FDA limited access to people over the age of 65 and people between the ages of 12 and 64 who have at least one underlying condition that puts them at risk of severe illness from a covid-19 infection.
https://gizmodo.com/marvel-is-delaying-avengers-doomsday-and-avengers-secret-wars-2000606340
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Moderna Pulls Promising Covid-Flu Combo Shot as RFK Continues Antivax Campaign (Original Post)
justaprogressive
Friday
OP
BoRaGard
(5,579 posts)1. It's almost as if worms have eaten G.O.P. brains
or they are intentionally evil
ProudMNDemocrat
(19,639 posts)2. RFK must be turning in his grave as to what Jr. is doing.
This is insanity to say the least. I will insist on my COVID-Flu vaccinations regardless.
Jr. can go fuck himself and the fat elephant he rode in on.