Written by Sharon LaFraniere, Noah Weiland and Sheryl Gay Stolberg
The Food and Drug Administration has informed Modern Pharmaceuticals that it can put up to 40% more coronavirus vaccine in each of its vials, a simple and potentially quick way to reinforce scarce supplies, according to people familiar with the operations of the company.
While federal officials want Moderna to present more data showing that the change will not compromise vaccine quality, the ongoing discussions are a hopeful sign that the nation’s vaccine stock could grow faster than expected, simply allowing it to the company loads up to 14 doses in each vial. instead of 10.
Moderna currently supplies about half of the country’s vaccine stocks. A 14-dose vial load could increase the country’s vaccine supply by as much as 20% at a time when governors are clamoring for more vaccines and the most contagious variants of the coronavirus are believed to be spreading rapidly.
Two people familiar with Moderna’s manufacturing, who spoke on condition of anonymity, said the remodeling of the company’s production lines to accommodate the change could be done in less than 10 weeks, or before the end of April. This is because while the amount of liquid in each vial would change, the vials themselves would remain the same size, so the production process would not change drastically. In a statement on Friday, Moderna estimated that the modifications could be made in two to three months.
“It would be a big step forward,” said Dr. Moncef Slaoui, who served as the scientific leader of the Trump administration’s vaccine development program. “I think it will have an impact in the short term.”
Last month Moderna asked permission to increase the number of doses in its vials to 15 from the industry standard of 10. The change would reduce the time required for the final manufacturing phase when millions of small bottles are filled. capping and labeling, a long-standing bottleneck in injectable drug manufacturing.
The company is also asking regulators to approve changes to the way its vaccine is stored and to allow doctors more time to use the doses in a vial once the rubber lining is punctured, all steps to increase flow into arms.
Slaoui cautioned that Moderna may still have to speed up its drug production to have more vaccines to fill the vials. “It is not clear whether it will be a 40% increase immediately or a 20% increase at the beginning,” he said. Another outside expert said the FDA could require an on-site inspection of the company’s manufacturing process if it changes.
In a recent email response to questions about the company’s discussions with regulators, Stéphane Bancel, Moderna’s chief executive, wrote: “No comment.” Ray Jordan, the company spokesman, said talks with federal officials were continuing. More exchanges with the FDA are expected before Moderna obtains final authorization for any changes.
On Thursday, President Joe Biden announced that the federal government had blocked a total of 600 million doses of vaccines from Moderna and Pfizer, which developed their drug with a German partner, BioNTech. Because each vaccine requires two doses, spaced three to four weeks apart, that would be enough to cover 300 million Americans.
So far, about 10% of Americans have received at least one dose of the vaccine. Pfizer has delivered about 52% of the national supply, while Moderna has delivered 48%, according to the CDC. While both companies are speeding up production, Moderna’s fuller vials, if approved, could lead it to the lead.
Pfizer manufacturing is geared towards six-dose vials, but Moderna’s vials have enough clearance to accommodate additional doses. However, there are limits to the amount of vaccine that can be added.
Too much could cause a vial to crack. Each vial should also contain enough space to ensure there is enough left to draw the final dose.
Regulations now specify that once pierced, the entire Moderna vial must be emptied within six hours, so filled vials could result in more waste if pharmacists struggle to extract more doses in that time frame.
The industry standard was set at 10 doses in part because the more times the rubber lining of a vial is punctured with a needle, the greater the risk of contamination. But Slaoui said those standards were not written for a pandemic that has now claimed the lives of more than 475,000 Americans.
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She is a freelance blogger, writer, and speaker, and writes for various entertainment magazines.