FDA open to Moderna proposal to increase vaccine doses in vials
By Laurie McGinley and Carolyn Y. Johnson
The Food and Drug Administration has told Moderna that it is open to allowing the biotech company to fill vials with additional doses of coronavirus vaccine — up to 14 from the current 10 — to increase throughput, according to an individual with knowledge of the situation who was not authorized to discuss the matter and spoke on the condition of anonymity.
However, the FDA has not officially approved the change. The company first must submit a proposed amendment to the agency’s emergency use authorization for the vaccine, which was issued Dec. 18. The agency is expected to quickly review it.
Moderna said earlier this month it would ask federal regulators for permission to fill vials with more doses in a bid to ease manufacturing bottlenecks and allow for more production. The company has said that a key capacity constraint is how many vials can be filled in a given period of time.
Moderna said in a statement Friday that it “continues to engage in discussions” with the FDA and other countries “about this potential increase in fill volumes, thus enabling extraction of additional doses from each vial delivered. The increased level of doses per vial would not require different vials than those being currently used.”
It also said it would take two to three months to implement the change after approval from regulators.
It is not clear how the change would affect the supply Moderna will provide to the United States and elsewhere. President Biden said Thursday that his administration had finalized deals to buy an additional 100 million doses of the Moderna and Pfizer-BioNTech vaccines, giving the country enough vaccine by the end of July to cover every American adult. Those transactions are in addition to previously bought supplies of 200 million doses each from Moderna and Pfizer-BioNTech, which are being delivered earlier.