WASHINGTON – The Food and Drug Administration has informed the modern pharmaceutical company that it can put up to 40% more coronavirus vaccine in each of its vials, a simple and potentially quick way to boost tense supplies, according to people familiar with the operations. from the company.
Although federal officials want Moderna to provide more data showing that the change would not compromise the quality of the vaccine, ongoing discussions are a promising sign that the country’s vaccine stock could increase faster than expected, simply by allowing the company load up to 14 doses in each bottle instead of 10.
Moderna currently supplies about half of the country’s vaccine stock. A 14-dose vial load could increase the country’s vaccine supply by up to 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 the manufacturing of Moderna, who spoke on condition of anonymity, said the redesign of the company’s production lines to accommodate the move could be done in less than 10 weeks, or before the end of April. That’s because, although the amount of liquid in each bottle changed, the bottles themselves would remain the same size, so the production process would not change dramatically.
“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 requested permission to increase the number of doses in its bottles to up to 15 from the industry standard of 10. The change would reduce the time needed for the final manufacturing stage, when millions of tiny bottles are filled, capped and labeled, a longstanding bottleneck in the manufacture of injectable drugs.
The company is also asking regulators to approve changes in the way its vaccine is stored and to allow healthcare professionals more time to use doses in a bottle once the rubber liner is punctured, all steps to increase flow to the arms.
Dr. Slaoui warned that Moderna may still have to increase its drug production so that it has more vaccine to fill the vials. “Whether it will be a 40% increase immediately or a 20% increase in the beginning” is unclear, he said. Another outside expert said that the FDA may require an on-site inspection of the company’s manufacturing process in the event of any changes.
In a recent email response to questions about the company’s discussions with regulators, Stéphane Bancel, CEO of Moderna, wrote: “No comment”. Ray Jordan, a spokesman for the company, said negotiations with federal officials continue.
On Thursday, President Biden announced that the federal government had blocked a total of 600 million doses of the vaccine from Moderna and Pfizer, who developed their drug with a German partner, BioNTech. Since each vaccine requires two doses, with an interval of three to four weeks, this would be enough to cover 300 million Americans.
But getting vaccine shipments out more quickly remains a priority. The Centers for Disease Control and Prevention have warned that in the next month, a significantly more contagious variant of the virus may become dominant. Another variant that appears to weaken the protection of existing vaccines has also appeared in the United States.
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 administering doses. But that argument will wear out as his term continues.
So far, about 10% of Americans have received at least one dose of the vaccine. Pfizer delivered about 52% of the national supply, while Moderna delivered 48%, according to the CDC. While both companies are accelerating production, fuller bottles of Moderna, if approved, could put it in the lead.
Pfizer’s manufacturing is aimed at six-dose bottles, but Moderna’s bottles have enough free space to accommodate extra doses. Still, there are limits to the amount of vaccine that can be introduced into them.
Furthermore, it can cause cracks in the bottle. Each vial must also contain enough space to ensure sufficient remnants to extract the final dose.
The regulations now specify that, once punctured, the entire bottle of Moderna should be emptied in six hours, so fuller bottles can lead to more waste if pharmacists struggle to extract more doses in that period of time.
The industry standard was set at 10 doses, in part because the more often the rubber lining of a bottle is punctured with a needle, the greater the risk of contamination. But Slaoui said those standards were not written for a pandemic that has already claimed the lives of more than 475,000 Americans.
The precise number of doses that can be extracted per bottle has become a highly worrying issue. Regulators have allowed Pfizer to label its bottles as containing six doses instead of five, so Pfizer is now receiving credit for administering more doses than before, although the amount has not changed. Six doses can be extracted if healthcare professionals use specialized syringes, and federal and state officials say the equipment is now included with every shipment of Pfizer vaccine.
Some doctors say the same ambiguity exists with Moderna’s product. Although the vials are labeled for 10 doses, they are sometimes able to withdraw an 11th dose using specialized syringes.
A third manufacturer, Johnson & Johnson, has applied to the FDA for approval of its single-dose vaccine for emergency use, and a decision may be made by the end of the month. The 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 speed up manufacturing.