@Hauler
Expedited review can take 6 months (average 10 in reality). Not sure on Moderna but Pfizer applied for Fast Track which guidelines say can be approved in 60 days. Pfizer applied July 13 and they are projecting an answer in September.
Interesting side note, they have replaced the head honcho in the FDA that will be approving this. They replaced the vaccine researcher with a biologics director.
@sparkuri !!!!
Under the FDA’s new plan, the director of FDA’s biologics center, Peter Marks, will largely oversee review of the Pfizer application, taking over for Marion Gruber, a 32-year veteran of the FDA who currently heads the office of vaccine research and review within the larger biologics center, according to a second FDA source. A third source familiar with the plan, who like the others spoke on condition of anonymity, said Marks was heavily involved in the review, but did not comment on whether he was formally replacing Gruber in the agency’s chain of command.