Moderna Wraps Up Covid Booster Filing, Setting Up FDA Review
(Bloomberg) -- Moderna Inc. said it completed its submission to U.S. regulators for clearance of a booster dose of its Covid-19 vaccine, starting the clock on a closely watched federal review.
The company announced the news in a tweet Friday, two days after saying that it had filed initial data concerning the supplemental dose with the Food and Drug Administration.
The drug regulator will now pore over the data and make a determination about whether it supports clearance of a third shot to enhance the immune protection afforded by the existing regimen. The rapid spread of the delta variant has stirred fears that the efficacy of messenger RNA vaccines made by Moderna and Pfizer Inc.-BioNTech SE could wane within months.
Moderna said when it filed its initial tranche of documentation Wednesday that the booster shot, given at half the 100-microgram dose already taken by more than 65 million Americans, raised antibody levels against delta by more than 40-fold in a clinical trial.
The Biden administration has said it wants to begin giving booster shots more widely beginning Sept. 20. With Moderna and Pfizer-BioNTech having both submitted full booster data, whether that target is met is in the lap of regulators at the FDA and the Centers for Disease Control and Prevention.
There have been signs in recent days that some officials and experts are chafing at what they perceive as political pressure to move quickly on a question where there is substantial scientific disagreement. Members of the CDC’s immunization advisory panel complained about the White House’s public comments on its booster plans at a meeting this week.
The FDA has scheduled a meeting of its vaccine advisory committee to scrutinize Pfizer’s submission for Sept. 17. It wasn’t clear Friday whether a separate meeting would be scheduled for the panel to weigh Moderna’s data.
Moderna also submitted booster-shot data to the European Medicines Agency for a conditional marketing approval, the company said in a statement late Friday.
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