F.D.A. Agrees Moderna Can Increase Vaccine Supply in Each Vial

[BumRushDaShow]

Source: New York Times

WASHINGTON — The Food and Drug Administration has informed the drugmaker Moderna that it can put up to 40 percent more coronavirus vaccine into each of its vials, a simple and potentially rapid way to bolster strained supplies, according to people familiar with the company’s operations. While federal officials want Moderna to submit more data showing the switch would not compromise vaccine quality, the continuing discussions are a hopeful sign that the nation’s vaccine stock could increase faster than expected, simply by allowing the company to load up to 14 doses in each vial instead of 10.

Moderna currently supplies about half of the nation’s vaccine stock. A 14-dose vial load could increase the nation’s vaccine supply by as much as 20 percent at a time when governors are clamoring for more vaccine and more contagious variants of the coronavirus are believed to be spreading quickly.

Two people familiar with Moderna’s manufacturing, who spoke on the condition of anonymity, said retooling the company’s production lines to accommodate the change could conceivably be done in fewer than 10 weeks, or before the end of April. That 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 drastically change. “It would be a great 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 for permission to increase the number of doses in its vials to as much as 15 from the industry standard of 10. The change would cut down on the time required for the final manufacturing phase when millions of tiny bottles are filled, capped and labeled, a longtime bottleneck in injectable drug manufacturing. The company is also asking regulators to approve changes in how its vaccine is stored and to allow health practitioners more time to use up the doses in a vial once the rubber coating is punctured, all steps to increase the flow into arms.

Read more: https://www.nytimes.com/2021/02/12/us/moderna-coronavirus-vaccine-supply.html

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They normally partially "overfill" the vials to allow for normal syringes to be able to pull the exact full quantity for the labeled number of doses per vial. However the overfill in this size vial apparently leaves enough headroom for more (am guessing with a low-volume syringe, some might have been able to get an 11th dose out). So if they can add just a bit more, they can get enough to pull an additional 4 doses and apparently still have a little left over to get a full aliquot of each.

[CaliforniaPeggy]

1. That sounds like a very good idea! n/t

[winstars]

2. Its definitely good news but "be done in fewer than 10 weeks, or before the end of April"

10 weeks is not 5 or 6 weeks... This thing is endless, though by June everything will be much much better IMHO...

[BumRushDaShow]

3. I think the reference is in terms of changing the calibration

for their automated manufacturing lines to increase the volume of liquid that will be dispensed in the vials, which is more than reprogramming in the new amount and then just flipping a switch. They would need to run multiple test batches with the new configuration and then assay some "x" number of vials in those batches to ensure that they contain the correct total concentration (within their stated range) of active ingredient in each vial. So there is a whole validation process that would need to happen before they are given the final go-ahead to go with the changed process and it would probably take that long so that they can be sure that their batches are not sub-potent or super-potent.

[Yo_Mama_Been_Loggin]

4. Good deal