Moderna has asked the U.S. Food and Drug Administration for permission to fill its Covid-19 vaccine bottles with up to five additional doses to alleviate a manufacturing bottleneck, one person familiar with the matter said.
The change would allow Moderna to put 15 doses in the same size vials that are now free of 10, relieving pressure on the part of the manufacturing process known as fill / finish, said the person, who refused to. are called because the application is not yet public.
The availability of Covid-19 vaccines has been a source of frustration since they were released in the US in mid-December. Although the rate of administration has increased to an average of more than 1 million per day, the limited supply has hindered the ability of states to operate massive vaccination centers. According to the Centers for Disease Control and Prevention, the US had distributed 49.2 million doses and delivered 27.9 million doses as of Friday.
“We have problems producing these mRNA vaccines,” says Dr. Paul Offit, director of the Vaccine Education Center and a physician at the Children’s Hospital of Philadelphia. “We have about 1.2 million doses a day while we need 3 million doses a day.”
The FDA declined to comment and delayed questions to the company. Moderna did not immediately respond to a request for comment.
Moderna’s move comes after Pfizer sought and obtained an amendment from the FDA in its emergency use authorization to specify that its Covid-19 vaccine vials contain six doses instead of five, after pharmacists observed that a bonus dose could be extracted with the right syringes. Pfizer then said it would deliver fewer vials to the US, but the same number of doses specified in its contracts.
Moderna’s vials were also found to contain a bonus dose, but it is looking for a regulatory change to add more volume to the vials.
The bottleneck is not the bottles themselves, according to the famous person, it is the production capacity to fill the bottles. The filling / finishing process in manufacturing must be done under aseptic conditions to ensure there is no contamination and capacity is scarce.
Companies have begun to enter into production partnerships aimed at this step in the process of increasing output. Novartis said Friday it has signed an initial agreement to fill vials for BioNTech, Pfizer’s partner in Europe for the Covid-19 vaccine.
“We expect this to be the first of a number of such agreements,” said Steffen Lang, head of Novartis Technical Operations.