‘We look forward to making our flu vaccine available later this year,’ Moderna CEO Stephane Bancel said.
The Food and Drug Administration has agreed to review a revised application from Moderna for its experimental influenza vaccine.
Moderna executives and FDA officials recently held a meeting, and after discussing the FDA’s recent refusal to consider an application for approval of the flu shot, Moderna filed an amended application.
“Discussions with the company led to a revised regulatory approach and an amended application, which FDA accepted,” Andrew Nixon, a spokesperson for the Department of Health and Human Services, the FDA’s parent agency, told The Epoch Times in an email on Feb. 18.
“FDA will maintain its high standards during review and potential licensure stages as it does with all products.”
“We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review,” Moderna CEO Stéphane Bancel said in a statement.
“Pending FDA approval, we look forward to making our flu vaccine available later this year so that America’s seniors have access to a new option to protect themselves against flu.”
Regulators recently declined to accept the original application for review. They took issue with how Moderna used in an efficacy trial a different flu vaccine that, while already approved by the FDA, is a standard dose rather than a high dose.
The Centers for Disease Control and Prevention recommends high-dose influenza vaccines for older adults.
“Your control arm does not reflect the best-available standard of care in the United States,” Dr. Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research, said in a Feb. 3 letter made public by Moderna.
“Moderna exposed participants age 65 and over to increased risk of severe illness by giving them a substandard of care against the recommendation of FDA scientists,” a spokesperson for the Department of Health and Human Services, the FDA’s parent agency, told The Epoch Times in an email.
Prasad said that officials recommended Moderna. If it disagreed with the refusal to accept the application, it should request an urgent meeting, known as a Type A meeting.
