- Moderna has asked U.S. regulators for permission to boost the number of doses in each vial of its coronavirus vaccine from 10 to as many as 15.
- The proposal, first reported by CNBC, is under consideration with the Food and Drug Administration and could be authorized in a matter of weeks. Adding as much as 50% more doses to each vial could help substantially increase the near-term supply of Moderna's vaccine. The biotech has said it expects to make between 600 million and 1 billion doses this year; the U.S. has ordered 200 million, and is in talks to acquire another 100 million.
- Moderna's plan is one of several steps developers and regulators are working on to urgently scale up production output for coronavirus vaccines. Over the past week, multiple large drugmakers have joined forces to help make, fill and distribute shots across Europe more quickly. The Biden administration is reportedly negotiating similar deals in the U.S.
The emergence of new coronavirus variants has intensified the already urgent push to immunize as many people as possible. Some variants appear to spread more quickly than the original version of SARS-CoV-2. Others are acquiring a mutation that may reduce the potency of vaccines and engineered antibody drugs. A recent report suggested another one possessing both features has been identified as well.
To help stem the spread of those variants — as well as the development of others — drugmakers and regulators are working on creative solutions to accelerate the pace of vaccinations. Some are focused on increasing manufacturing capacity. Sanofi and Novartis, for instance, each cut separate deals with Pfizer and BioNTech to help the partners fill and ship more vaccine doses. Novartis said last week that it's working on other, similar deals. And Merck KGaA is reportedly considering helping Pfizer and BioNTech as well.
Addressing constrained capacity, however, will take time. In the near term, manufacturers are attempting to get more doses out of each vaccine vial they fill and ship.
The Food and Drug Administration, for instance, recently cleared new labeling for Pfizer and BioNTech's vaccine to indicate each vial holds six doses, rather than five.
The change came after some vaccinators found extra doses in vials of Pfizer's shot, leading the pharma to ask the FDA to change the language in its vaccine authorization. As a result, Pfizer is now shipping fewer vials to meet its contracted deliveries, arguing the "extra" doses count towards the total number the U.S. preordered.
Moderna now has similar plans. In an e-mailed statement, company president Stephen Hoge confirmed Moderna has asked for FDA clearance to fill vials with as many as 15 doses of its vaccine, up from 10, which would "address one of the manufacturing bottlenecks and ... allow for additional production."
A Moderna spokesperson said the company would need to have further discussions with the FDA to "assure the agency's comfort with this approach before implementing.”"The company declined to comment on potential timing, though a New York Times report suggested a decision could come within a few weeks.
The U.S. has administered roughly 14.8 million shots of Moderna's vaccine since its clearance in December, according to data from the Centers for Disease Control and Prevention.