Moderna is asking the FDA to permit 5 further doses per Covid vaccine bottle: supply

Moderna has asked the U.S. Food and Drug Administration for permission to fill their Covid-19 vaccine bottles with up to five extra doses to help clear a manufacturing bottleneck, according to a person familiar with the matter.

The change would allow Moderna to fill 15 cans into vials of the same size, now cleared for 10, which eases the pressure on the manufacturing process known as filling / finishing, said the person who refused to named because the application is not public yet.

The availability of Covid-19 vaccines has caused frustration since their approval in the US in mid-December. While the pace of administration has increased to an average of more than 1 million a day, the limited supply has hampered states’ ability to operate mass vaccination centers. By Friday, the US had distributed 49.2 million doses and 27.9 million had been administered, according to the Centers for Disease Control and Prevention.

“We have problems making these mRNA vaccines,” said Dr. Paul Offit, director of the Vaccine Education Center and a doctor at the Children’s Hospital in Philadelphia. “We have up to 1.2 million doses a day when we need 3 million doses a day.”

The FDA declined to comment and asked questions to the company. Moderna did not immediately respond to a request for comment.

The switch from Moderna came after Pfizer requested and received a change to FDA approval for emergency use to state that the Covid-19 vaccine bottles contain six doses instead of five after pharmacists determined that a bonus dose was correct Syringes could be extracted. Pfizer then said it would ship fewer vials to the US, but the same number of doses specified in its contracts.

Moderna vials have also been found to contain a bonus dose, however a policy change is sought to add volume to the vials.

The bottleneck is not the bottles themselves, but the production capacity for filling the bottles. The manufacturing filling / finishing process must be performed under aseptic conditions to avoid contamination and the capacity is high.

Companies have started to form manufacturing partnerships that focus on this step in the process to increase production. Novartis announced on Friday that it had signed an initial vial fill agreement for BioNTech, Pfizer’s partner in Europe, for the Covid-19 vaccine.

“We expect this to be the first in a series of such agreements,” said Steffen Lang, head of technical operations at Novartis.

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