It seems like a solution that’s almost too simple: Make more COVID-19 vaccines available by allowing one of the drug manufacturers to increase the amount of vaccine inserted into each vial.
Moderna is asking the federal Food and Drug Administration to allow it to fill the empty space in the vials used to package its vaccine. The vials now are filled with 10 doses of the drug, but company officials say they can easily fill the vials with up to 15 doses. That would amount to a 50% increase at a time when health officials nationwide are clamoring for additional shipments to inoculate the millions of people awaiting the vaccine.
Federal health officials should move quickly to determine there are no safety issues with increasing the number of doses in a vial and expedite the request from Moderna.
Company officials said they could produce more vaccine and increase the quantity of shipments with the simple change, although they did not say how quickly they could adjust production.
The increase would address a problem in what health officials call the “fill and finish” phase of the manufacturing process. Moderna has been increasing its vaccine production, but has run into a bottleneck in the final phase where vials are filled and labeled. Increasing the amount in the vial would help alleviate the bottleneck with little change to the process.
Although the industry standard has long been 10 doses per vial, FDA officials must consider this option to quickly increase availability of the vaccine. There are concerns that higher doses per vial could increase the risk of bacterial contamination because of the additional times a syringe would puncture the rubber covering of the vial. Officials also worry that fuller vials may be more prone to breaking.
Those are valid concerns that should be analyzed, but assessments should be done quickly to address the ongoing shortage. Even if the FDA balks at 15 doses per vial, an increase to even 12 doses would mean a 20% increase in availability.
The other vaccine now in use is produced by Pfizer-BioNTech, but the size of the vials it uses limits capacity to six doses.
The two companies have promised to each deliver 200 million doses by July — enough to cover roughly three-fourths of the country’s adult population — but that timetable could be moved up considerably by boosting the dosage per vial. If a third vaccine from Johnson & Johnson now being tested for use gets FDA approval, health officials say the entire U.S. population could be vaccinated by early summer.
The request from Moderna is one of several options federal officials are considering to increase vaccine availability. It’s one that seems to promise both expediency and low risk. The FDA must make the proposal a priority.
— Tribune News Service
