Politics

FDA allows Moderna to increase vaccine dose in each vial

The US Food and Drug Administration (FDA) has informed the drugmaker Moderna that it can put up to 40 percent more coronavirus vaccine into each of its vials, a simple and potentially rapid way to bolster strained supplies, according to people familiar with the company’s operations.

Report informs with reference to the New York Times.

While federal officials want Moderna to submit more data showing the switch would not compromise vaccine quality, the continuing discussions are a hopeful sign that the nation’s vaccine stock could increase faster than expected, simply by allowing the company to load up to 14 doses in each vial instead of 10.

Moderna currently supplies about half of the nation’s vaccine stock. A 14-dose vial load could increase the nation’s vaccine supply by as much as 20 percent.

Two people familiar with Moderna’s manufacturing, who spoke on the condition of anonymity, said retooling the company’s production lines to accommodate the change could conceivably be done in fewer than 10 weeks, or before the end of April. The amount of liquid in each vial would change, the vials themselves would remain the same size, so the production process would not drastically change.

Last month, Moderna asked for permission to increase the number of doses in its vials to as much as 15 from the industry standard of 10. The change would cut down on the time required for the final manufacturing phase when millions of tiny bottles are filled, capped and labeled, a longtime bottleneck in injectable drug manufacturing.

Report

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