Dr. Marks said he was barred from commenting about pending requests from pharmaceutical companies. But he said that vaccine manufacturers usually announce publicly when their applications are finished. “You can surmise what the situation is, because we will proceed with all due speed once we have completed applications,” he said.
Both Moderna and the partnership of Pfizer and BioNTech are developing doses of their coronavirus vaccines for very young children, but Moderna appears to be closer to filing its request for emergency authorization. A Moderna spokeswoman said last week that the company expects to file by the end of April, but did not say whether the company’s application would be complete by then. Pfizer is expected to file its application in May. Many such applications involve rolling submissions of data.
In an interview Thursday with C.N.N.+, Dr. Anthony S. Fauci, the chief medical adviser to the White House, suggested that the F.D.A. wanted to review data from Moderna and Pfizer simultaneously, in order to directly compare the merits of the companies’ vaccines and not “confuse people.” Moderna is proposing a two-shot dosing plan for children under 6, while Pfizer is developing a three-shot vaccination using weaker individual doses for children under 5.
Dr. Fauci’s comment prompted questions about whether the F.D.A. was deliberately holding up Moderna’s request to allow Pfizer to catch up. If so, then regulators would be “failing millions of parents and young children,” Dr. Zachary Rubin, an Illinois pediatric allergist, wrote o. Twitter. “If they are waiting for @pfizer to be ready, then something is rancid.”
In a letter to the F.D.A. on Monday, Rep. James E. Clyburn, Democrat of South Carolina and chairman of a House select subcommittee on the pandemic, wrote that waiting for Pfizer’s application could delay the authorization of Moderna’s vaccine by several weeks. He asked F.D.A. officials to brief the subcommittee’s staff on their plans.