HealthDay News — A decision on whether to allow Moderna to increase the number of doses in its vials of COVID-19 vaccine is expected from the U.S. Food and Drug Administration within a few weeks.
The Moderna vaccine is one of two approved COVID-19 vaccines in the United States, and boosting the number of doses in its vials could increase vaccination rates across the nation, The New York Times reported. The company would like to bump the number of doses in its vials from 10 to as many as 15.
While it has discussed the proposed change with the FDA, Moderna has not yet provided the agency with manufacturing data to support it, people familiar with the discussions said, The Times reported. The FDA may be open to the idea of permitting more doses in each vial but may not be willing to approve a 50 percent increase, the newspaper said.
There are potential downsides to putting more vaccine in each vial: The industry standard has long been 10 doses per vial, and federal regulators may be concerned that the extra punctures by needles of the rubber covering of the vial and the time required to extract more doses could raise the risk for contaminating the vaccine. And at some point, too much liquid can cause a vial to break.
Putting more vaccine into each vial could also lead to more wasted doses if a health care professional runs out of people to give shots to and has to throw out the rest of the vial. But in the midst of a pandemic, experts said, that may well be a risk that federal health officials would be willing to take, The Times reported.