According to a person familiar with the matter, Moderna has asked the U.S. Food and Drug Administration for permission to supplement its Covid-19 vaccination scales with up to five additional doses.
The change allows Moderna to place 15 doses in the same size vials that have now been cleaned to hold 10, relieving the pressure of the manufacturing process, known as filling / finishing, said the person, who refused has to be named because the application does not disclose anyway.
The availability of Covid-19 vaccines has been a source of frustration since they were approved in the US in mid-December. While the pace of administration averaged more than 1 million a day, limited supply hampered the ability of states to conduct mass vaccinations. According to the Centers for Disease Control and Prevention, the U.S. distributed 49.2 million doses as of Friday, and 27.9 million were administered.
“We have problems with the production of these mRNA vaccines,” said Dr. Paul Offit, director of the Center for Vaccines and a physician at Philadelphia Children’s Hospital, said. “We are about 1.2 million doses a day when we need to have 3 million doses a day.”
The FDA declined to comment and postponed questions to the company. Moderna did not immediately respond to a request for comment.
The Moderna move comes after Pfizer sought and obtained an FDA change in emergency authorization to specify that the Covid-19 vaccine vials contain six doses, rather than five, after pharmacists noted that a bonus dose with the real syringes could be withdrawn. Pfizer then said it would deliver fewer vials in the US, but the same number of doses as indicated in the contracts.
Moderna’s vials have also been found to contain a bonus dose, but it is seeking a change in regulation to add more volume to the vials.
The bottle neck is not the vials, according to the famous person it is the manufacturing ability to fill the vials. The filling / finishing process in the manufacture must be done under aseptic conditions to ensure no contamination, and the capacity is high.
Companies have started making manufacturing partnerships, focusing on this step in the process of increasing production. Novartis said on Friday it had signed an initial agreement to fill bottles for BioNTech, Pfizer’s European partner, over 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.