FDA agrees Moderna can increase vaccine supply in each vial

FDA agrees Moderna can increase vaccine supply in each vial

cbaker_admin
Tue, 02/16/2021 – 23:00

FDA has concluded that Moderna may place up to 40% more COVID-19 vaccine into each of its vials. The increase could allow the company to load up to 14 doses in each vial instead of 10. Last month, Moderna sought permission to increase the number of doses in its vials to as much as 15 to cut the time required to fill, cap, and label millions of vials. The company also asked regulators to approve changes in how its vaccine is stored and allow health care providers to have more time to administer doses from a vial once its rubber coating is punctured. Federal officials still require Moderna to provide more data to indicate that increasing the doses per vial would not affect vaccine quality. Moderna currently supplies roughly one-half of the nation’s COVID-19 vaccine stock. People familiar with Moderna’s manufacturing say revising the company’s production lines to accommodate the change could potentially be accomplished in fewer than 10 weeks, or before the end of April. Moderna estimated on Friday that modifications could be made within 2-3 months.