Moderna has asked the United States Food and Drug Administration for permission to fill its Covid-19 vaccine bottles with up to five additional doses to ease a bottleneck in manufacturing, according to a person familiar with the matter.
The change would allow Moderna to place 15 doses in vials of the same size now released to contain 10, relieving pressure on the part of the manufacturing process known as filling / finishing, said the person, who did not want to be identified because the application is not yet public. .
The availability of Covid-19 vaccines has been a source of frustration since its release in the United States in mid-December. Although the pace of administration has increased to more than 1 million per day on average, the restricted supply has hampered states’ ability to operate mass vaccination sites. As of Friday, the United States had distributed 49.2 million doses and 27.9 million were administered, according to the Centers for Disease Control and Prevention.
“We are having trouble producing these mRNA vaccines,” said Dr. Paul Offit, director of the Vaccine Education Center and physician at Children’s Hospital of Philadelphia. “We have about 1.2 million doses a day, when we need to take 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.
Moderna’s move comes after Pfizer sought and obtained an FDA change in its emergency use authorization to specify that its Covid-19 vaccine bottles contain six doses, instead of five, after pharmacists noted that one dose bonuses could be extracted with the right syringes. Pfizer then said it would deliver fewer bottles to the United States, but the same number of doses specified in its contracts.
Moderna’s vials also contained a bonus dose, but she is seeking a regulatory change to add more volume to the vials.
The bottleneck is not the bottles themselves, according to a family member, it is the manufacturing capacity to fill the bottles. The filling / finishing process in manufacturing must be done under aseptic conditions to ensure that there is no contamination, and capacity is minimal.
The companies started to enter into manufacturing partnerships focusing on this stage of the process to increase production. Novartis said on Friday that it signed an initial agreement to fill bottles for BioNTech, Pfizer’s European partner in the Covid-19 vaccine.
“We hope this will be the first in a series of such deals,” said Steffen Lang, head of Technical Operations at Novartis.