TUESDAY, Feb. 2, 2021 (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.
Moderna’s vaccine is one of two approved coronavirus 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. The current dose limit is slowing Moderna’s output of the vaccine, company spokesman Ray Jordan said in a statement.
While it’s discussed the proposed change with the FDA, Moderna hasn’t 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% 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 of contaminating the vaccine.
And at some point, too much liquid can cause a vial to break. Moderna has tested what happens when it adds additional doses, and determined that the limit is 15 doses, according to people familiar with the company’s operations who were not authorized to speak publicly, the Times reported.
Putting more vaccine into each vial could also lead to more wasted doses if a health care professional runs out of people to get shots 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.
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