FDA Agrees Moderna Can Enhance Vaccine Provide in Every Vial

FDA Agrees Moderna Can Increase Vaccine Supply in Each Vial

WASHINGTON – The Food and Drug Administration has informed drug maker Moderna that it can add up to 40 percent more coronavirus vaccines to each of its vials.

While federal officials want Moderna to come up with more data showing the switch wouldn't affect vaccine quality, the ongoing discussions are a hopeful sign that the country's vaccine inventory could grow faster than expected by simply adding up to 14 doses can load into each vial instead of 10.

Moderna currently supplies around half of the national vaccine inventory. A 14-dose vial could increase the country's vaccine supply by up to 20 percent if governors ask for more vaccines and more contagious variants of the coronavirus are likely to spread quickly.

Two people familiar with Moderna's manufacturing, speaking on condition of anonymity, said a retooling of the company's production lines to accommodate the change could possibly be done in less than 10 weeks or before the end of April. This 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 change drastically. In a statement Friday, Moderna estimated that changes could be made in two to three months.

"It would be a big step forward," said Dr. Moncef Slaoui, who served as the science director of the Trump administration's vaccine development program. "I think that will affect the short term."

Last month, Moderna asked for permission to increase the number of doses in its vials from the industry standard from 10 to up to 15. The change would reduce the time it takes to the final manufacturing phase when millions of tiny bottles are filled. sealed and labeled, a longstanding bottleneck in the manufacture of injectable drugs.

The company is also urging regulators to approve changes to the vaccine storage and give doctors more time to use up the doses in a vial once the rubber coating is punctured. These are all steps to increase the flow into your arms.

Dr. Slaoui warned that Moderna may still have to stop its drug production so it has more vaccine to fill the vials. "It is unclear whether it is 40 percent immediately or 20 percent initially," he said. Another outside expert said the F.D.A. An on-site review of the company's manufacturing process may be required if it changes.

In a recent email response to questions about the company's discussions with regulators, Moderna CEO Stéphane Bancel wrote: "No comment." Ray Jordan, the company's spokesman, said talks with federal officials would continue. More back and forth with the F.D.A. expected before Moderna receives final approval for changes.

On Thursday, President Biden announced that the federal government had locked up a total of 600 million vaccine doses from Moderna and Pfizer, who developed their drug with a German partner, BioNTech. Since each vaccine requires two doses three to four weeks apart, that would be enough to cover 300 million Americans.


Feb. 12, 2021, 11:21 p.m. ET

However, faster delivery of vaccines remains a top priority. The Centers for Disease Control and Prevention has warned that a significantly more contagious variant of the virus could dominate by next month. Another variant that appears to weaken the protection of existing vaccines has also emerged in the United States.

Mr Biden said Thursday that the nation will not be able to vaccinate all Americans by the end of summer, citing "gigantic" logistical challenges. He accused the Trump administration of failing to create a better system for managing gunfire. But this argument gets thinner and thinner as the term of office progresses.

To date, about 10 percent of Americans have received at least one dose of vaccine. Pfizer supplied around 52 percent of the national supply, while Moderna, according to C.D.C. As both companies accelerate production, if approved, Moderna fuller vials could take the lead.

Pfizer's manufacturing is geared towards six-dose vials, but the Moderna vials provide enough free space for additional doses. Even so, there are limits to how much vaccine can be crammed into them.

Too much can crack a vial. Each vial must also contain enough space to ensure that there is enough residue to extract the final dose.

The regulations now state that the entire vial of Moderna must be emptied within six hours of a puncture, so fuller vials can lead to more waste if pharmacists have difficulty extracting more doses during this period.

The industry standard was set at 10 doses, in part because the number of times a vial's rubber coating is pierced with a needle, the greater the risk of contamination. But Dr. Slaoui said these standards were not written for a pandemic that had now claimed the lives of more than 475,000 Americans.

The exact number of doses that can be extracted per vial has become an extremely difficult problem. Regulators allowed Pfizer to re-label its six-dose vials instead of five. As a result, Pfizer is now receiving credit for dispensing more doses than before, even though the amount has not changed. Six doses can be extracted if doctors use special syringes, and federal and state officials say the kit is now included in every shipment of the Pfizer vaccine.

Some naturopaths say the same ambiguity persists with Moderna's product. While the vials are labeled for 10 doses, it was sometimes possible to withdraw an 11th dose with special syringes.

A third manufacturer, Johnson & Johnson, has the F.D.A. The single-dose emergency vaccine could be approved by the end of the month. The company has promised to ship another 100 million cans by the end of June, but federal officials say the company is still trying to speed up its manufacturing.


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