Modern asked the US Food and Drug Administration for permission to fill its vials of Covid-19 vaccine with up to five additional doses to ease the blockage in the manufacturing process, according to a person familiar with the problem.
The change would allow Moderna to put 15 doses in vials of the same size now removed to maintain 10, easing pressure from the manufacturing process known as filling / finishing, said the person who refused to be named because the application is not yet public. .
The availability of Covid-19 vaccines has been a source of frustration since their elimination in the United States in mid-December. While the pace of administration has increased by an average of more than 1 million a day, limited supply has hampered the ability of states to operate mass vaccination sites. As of Friday, the United States 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 producing these mRNA vaccines,” said Dr. Paul Offit, director of the Vaccine Education Center and physician at Children’s Hospital of Philadelphia. “We’re up to about 1.2 million doses a day, when we have to be at 3 million doses a day.”
The FDA declined to comment, postponing questions to the company. Moderna did not immediately respond to a request for comment.
The move to Moderna comes after Pfizer sought and obtained a change from the FDA in the emergency use authorization to specify its Covid-19 vaccine vials contain six doses, rather than five, after pharmacists noticed that a the bonus dose could be extracted with the appropriate syringes. Pfizer then said it would deliver fewer vials to the United States, but the same number of doses specified in its contracts.
It has also been found that Moderna vials contain a bonus dose, but are looking for a regulatory change to add more volume to the vials.
The blockage is not the vials themselves, according to the family person, it is the manufacturing ability to fill the vials. The manufacturing filling / finishing process must be performed in aseptic conditions to ensure that there is no contamination and the capacity is at a higher level.
Companies have begun to enter into production partnerships focused on this step in the process of increasing production. Novartis said on Friday it had signed an initial bottle-filling agreement for BioNTech, Pfizer’s European partner on the Covid-19 vaccine.
“We expect it to be the first in a series of such agreements,” said Steffen Lang, head of technical operations at Novartis.