WASHINGTON – The Food and Drug Administration has informed drug manufacturer Moderna that it can put up to 40 percent more coronavirus vaccine in each of its vials, a simple and potentially quick way to support strained stocks, according to people familiar with the activities of the drug. company.
While federal officials want Moderna to submit more data showing that the switch will not jeopardize vaccine quality, the ongoing discussions are a hopeful sign that the nation’s vaccine supply could grow faster than expected, simply by adding the company to stand to load up to 14 doses in each vial instead of 10.
Moderna currently supplies about half of the country’s vaccine supply. A 14-dose vial 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 rapidly.
Two people familiar with Moderna’s production, speaking on condition of anonymity, said adjusting the company’s production lines to accommodate the change could potentially be done in less than 10 weeks or before the end of April. That’s because while the amount of liquid in each bottle would change, the bottles themselves would remain the same size, so the manufacturing process wouldn’t change drastically.
“It would be a big 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 reduce the time it takes for the final stage of production when millions of small bottles are filled. covered and labeled, a long-standing bottleneck in injectable drug production.
The company is also asking regulators to approve changes to the storage of the vaccine and to give health professionals more time to use up the doses in a vial once the rubber coating is punctured, all steps to reduce flow to the arms. to increase.
Dr. Slaoui warned that Moderna may need to speed up its drug production so that it had more vaccine to fill the vials. “Whether it will be an increase of 40 percent initially or 20 percent initially,” is unclear, he said. Another outside expert said the FDA may require an on-site inspection of the company’s manufacturing process if it changes.
In a recent email response to questions about the company’s discussions with regulators, Stéphane Bancel, Moderna’s CEO, wrote, “No comment.” Ray Jordan, the company spokesman, said talks with federal officials were continuing.
On Thursday, President Biden announced that the federal government had locked down a total of 600 million doses of vaccine from Moderna and Pfizer, who were developing his drug together 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.
But delivering vaccines faster remains a top priority. The Centers for Disease Control and Prevention have warned that by next month, a significantly more contagious variant of the virus could become dominant. Another variant that appears to weaken the protection of existing vaccines has also emerged in the United States.
Mr Biden said the country would not be able to vaccinate all Americans by the end of the summer, citing “gigantic” logistical challenges. He blamed the Trump administration for not creating a better system for shooting. But that argument will grow weaker as his tenure progresses.
So far, about 10 percent of Americans have received at least one dose of the vaccine. Pfizer provided about 52 percent of the national supply, according to the CDC, while Moderna delivered 48 percent, according to the CDC. While both companies are speeding up production, fuller bottles from Moderna, if approved, can put it in charge.
Pfizer’s production is focused on six-dose vials, but Moderna vials have ample clearance for additional doses. Yet there are limits to the amount of vaccine that can be crammed into it.
Too much can cause a vial to rupture. Each vial should also have enough space to ensure that there is enough left to extract the last dose.
The regulations now specify that once punctured, the entire Moderna vial must be emptied within six hours, so fuller vials can lead to more waste if pharmacists struggle to extract more doses during that time.
The industry standard was set at 10 doses, in part because the more often the rubber coating of a vial is pierced with a needle, the greater the risk of contamination. But Dr. Slaoui said those standards were not written for a pandemic that had now claimed the lives of more than 475,000 Americans.
The precise number of doses that can be extracted per vial has become a very fraught issue. Regulatory agencies allowed Pfizer to relabel its vials with six doses instead of five, so Pfizer now gets the credit for delivering more doses than before, although the quantity has not changed. Six doses can be extracted if health professionals use specialized syringes, and federal and state officials say equipment now comes with every shipment of Pfizer vaccine.
Some health professionals say the same ambiguity exists with Moderna’s product. Although the bottles are labeled for 10 doses, they have sometimes managed to draw up an 11th dose with special syringes.
A third manufacturer, Johnson & Johnson, has asked the FDA to approve the single-dose vaccine for emergency use, and a decision could be made by the end of the month. That company has promised to deliver an additional 100 million doses by the end of June, but federal officials say the company is still trying to ramp up production.