Moderna expected to miss Sept. 20 deadline for booster approval

WASHINGTON — U.S. regulators don’t expect to meet the Biden administration’s Sept. 20 timeline of making booster shots widely available to those who received the Moderna Covid vaccine, said a person familiar with the process.

Top health officials informed the White House they will need more time to review the Moderna application because the data the company submitted Sept. 1 was “found inadequate and needs strengthening,” the person said.

But officials believe regulators are still on track to make a decision on boosters for Pfizer’s vaccine by Sept. 20. The FDA has an advisory committee meeting scheduled to discuss the Pfizer boosters Sept. 17, the person said.

“These things happen and are part of the process,” the person said. “We have and will continue to follow the science.”

Top U.S. health officials announced Aug. 18 that the country plans to start offering Covid-19 booster shots to all Americans beginning the third week of September, citing evidence that protection against infection is waning, as the highly contagious delta variant continues to spread. The missed deadline could mean that only those who received Pfizer’s vaccine can get a booster for at least several more weeks.

“We always said we would follow the science and this is all part of a process that is now underway,” said White House spokesman Chris Meagher. “We are awaiting a full review and approval by the FDA and a recommendation by the ACIP. When that approval and recommendation are made, we will be ready to implement the plan our nation’s top doctors developed so that we are staying ahead of this virus.”

While officials said the timeframe was contingent on the FDA’s review, it was a highly unusual move for the most senior health officials to make such a strong recommendation before the FDA has completed their work.

The New York Times was first to report the delay.

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