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Moderna Receives FDA Nod to Add More Vaccine to Vials: Report

The change will allow Moderna to put 14 doses in each vial, up from 10 previously. Moderna now accounts for about 50% of U.S. supply.
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Moderna  (MRNA) - Get Moderna Inc. Report has received permission from the Food and Drug Administration to pack up to 40% more of its Covid vaccine into each vial to reduce a key production bottleneck, knowledgeable sources told The New York Times.

The size of vials used in distribution would remain the same, but putting more doses in each improve productivity and reduce the time needed for labeling and capping, the paper reported. 

U.S. regulators still want more data from Moderna showing vaccine quality won’t suffer from the increase, The Times said. The change will allow Moderna to put 14 doses in each vial, up from 10 previously, the industry standard for vaccine distribution. Moderna now accounts for about 50% of the U.S. vaccine supply.

The Times sources said Moderna can redo its manufacturing process to accommodate the increase in less than 10 weeks. In January, Moderna had sought permission to lift dosages to 15 per vial.

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So far, more than 30 million Americans have received at least one vaccine dose -- 52% from Pfizer  (PFE) - Get Pfizer Inc. Report and 48% from Moderna, according to The Times.

Friday’s news had little impact on Moderna shares. They recently traded up 0.12% at $183.66. The stock has skyrocketed 758% over the last year amid investor enthusiasm over vaccines.

Earlier this month, Bank of America analyst Geoff Meacham downgraded Moderna to underperform from neutral with a $150 price target, saying the company's valuation was stretched.

The stock is "attaining levels that are increasingly difficult to justify on a fundamental basis," he said. “The momentum has continued despite new covid-19 vaccine data from Novavax  (NVAX) - Get Novavax Inc. Report and Johnson & Johnson's  (JNJ) - Get Johnson & Johnson Report phase 3 study approval."

Meacham said that Moderna and Pfizer have best-in-class efficacy thus far, "but volumes and lower price points from Novavax, JNJ, Astra-Zeneca  (AZN) - Get AstraZeneca PLC Report and others should affect cumulative sales expectations from Moderna.”