Moderna has asked permission from the U.S. Food and Drug Administration to fill its Covid-19 vaccine vials with up to five additional doses to facilitate bottlenecks in manufacturing, according to a person familiar with the matter. .
The change would allow Moderna to put 15 doses in the vials of the same size that 10 can now be preserved, relieving the pressure of the manufacturing process known as filling / finishing, said the person who rejected the name because the application did not it is still public.
The availability of Covid-19 vaccines has been a source of frustration since they were phased out in the U.S. in mid-December. While the pace of administration has increased to more than a million a day on average, restricted 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 trouble producing these mRNA vaccines,” said Dr. Paul Offit, director of the Vaccine Education Center and physician at Philadelphia Children’s Hospital. “We have up to about 1.2 million doses a day when we need 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.
Moderna’s move comes after Pfizer sought and obtained a change from the FDA in its emergency use authorization to specify that its Covid-19 vaccine vials contain six doses, rather than five, after the pharmacists noted that an additional dose could be extracted with the appropriate syringes. Pfizer then said it would deliver fewer vials to the US, but the same number of doses specified in its contracts.
It was also found that Moderna vials contained an additional dose, but is looking for a regulatory change to add more volume to the vials.
According to the family person, the bottleneck is not the vials, but the manufacturing capacity to fill the vials. The filling / finishing process of the manufacture must be done in aseptic conditions to ensure contamination and the capacity is maximum.
Companies have begun to establish manufacturing partnerships focused on this step of the process to increase production. Novartis said Friday that it signed an initial agreement to fill vials for BioNTech, Pfizer’s partner in Europe on the Covid-19 vaccine.
“We hope this is the first of these agreements,” said Steffen Lang, Novartis ’chief technical officer.