US FDA changes stance and agrees to review Moderna’s mRNA flu vaccine application
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Moderna says the US Food and Drug Administration (FDA) has agreed to review its influenza vaccine after the company made amendments, reversing an earlier decision to reject the application.
The change announced Wednesday comes just a week after the FDA’s surprise decision not to review the company’s experimental flu vaccine application.
The FDA has accepted Moderna’s revised approach, which calls for full approval for the shot for adults ages 50 to 64 and accelerated approval for those ages 65 and older. company It will also conduct post-marketing studies in older adults, he said.
The mRNA technology used in Moderna and most other COVID-19 shots, which are credited with saving millions of lives, comes with a change in health policy under U.S. Health Secretary Robert F. Kennedy Jr., a longtime anti-vaccine activist who has been particularly critical of mRNA vaccines.
US Health Secretary Robert F. Kennedy Jr. has canceled $500 million in funding for the development of MNRA vaccine technology. For The National, CBC’s Heather Hiscox asked infectious disease expert Dr. Alison McGirr and health researcher Bradley Wouters to explain what kind of impact it could have on fighting the disease in Canada and around the world.
The regulator had defended its initial decision, saying the company should have given the higher potency vaccine to older patients in the control arm of its trial.
“Pending FDA approval, we look forward to making our flu vaccine available later this year so America’s seniors can have access to a new option to protect themselves from the flu,” said Stephane Bancel, CEO of Moderna.
The regulator is expected to take a decision on the candidate by August 5.
