[ad_1]
Upstart drugmaker Moderna is asking U.S. regulators to allow it to increase the amount of coronavirus vaccine put in each vial by up to 50%, arguing it can speed vaccines to patients by eliminating a simple manufacturing bottleneck: bottling drugs.
The Food and Drug Administration could decide within a few weeks how much vaccine Moderna, the developer of one of the two federally authorized Covid-19 vaccines, can put in its vials. Moderna says he can increase the number of doses per vial from 10 to 15.
The company has already ramped up production of its vaccine, only to find a bottleneck in the bottling, capping and labeling process. With FDA approval, more doses could quickly start entering each bottle, a welcome boost to the campaign to stem a pandemic that has killed more than 440,000 people in the United States alone. In a statement Monday night, Ray Jordan, a spokesperson for Moderna, said the vial dosage constraint was limiting Moderna’s production.
The Moderna proposal is part of a larger push by the Biden administration to speed up vaccine distribution, including removing barriers in the “fill and finish” phase of manufacturing. Although the nut-and-bolt stage receives less attention than vaccine development, it has been identified for years as a constraint on vaccine production.
White House Covid-19 response coordinator Jeffrey D. Zients said on Tuesday the federal government will allocate a minimum of 10.5 million doses of coronavirus vaccine to states for the next three weeks, an increase by five percent resulting from an increase in manufacturing.
At a White House press conference, Mr Zients presented the increase in doses as an achievement of the Biden administration, claiming that “we have increased supply by over 20% since taking office. “. But the rise in production is long overdue, as companies that make two federally licensed vaccines, one from Pfizer and BioNTech and the other from Moderna, have stepped up their efforts. Last week, companies increased their supply to the United States by 16%.
Governors were informed of the increase during a call Tuesday morning so they would have more time to schedule vaccinations, Zients said, with three weeks’ notice for the new allocation numbers – a cornerstone of a new effort by the Biden administration to improve a distribution system mired in uncertainty and confusion over limited supply and unused doses.
“It allows them to plan accordingly and know what endowment needs to have,” he said. “I think historically there have been fluctuations. We are very inclined not to have this fluctuation. “
Moderna has discussed the possible change in the number of doses in the vials with the FDA, but has not yet submitted supporting manufacturing data, people familiar with the discussions said. Federal regulators may be receptive to the idea of more doses in each vial, but might balk at the idea of a 50 percent increase.
The industry standard has long been 10 doses per vial, and federal regulators may be concerned that additional needle punctures in the rubber coating of the vial and the time required to extract more doses may increase the risk of contamination of the vial. vaccine by bacteria.
At one point, too much liquid can cause a vial to rupture. Moderna has tested what happens when he adds extra doses and has determined that the limit is 15 doses, according to people familiar with the company’s operations who were not authorized to speak publicly. Moderna’s proposal to the FDA for dose escalation first reported by CNBC.
Packing more vaccine into each vial of Moderna is one of the many options the White House and health officials are exploring as they try to ramp up production before spring, as officials expect a upsurge in infections due to emerging variants of the virus. Some proposals have already been considered and rejected, including a suggestion to combine the remaining dose fractions in vials.
The manufacturer of the other federally approved vaccine, Pfizer, is unable to increase the amount of vaccine in its vials because its manufacture is geared toward a particular vial size that can only hold about six doses. But Moderna’s vial is large enough to hold more than the 10 doses currently allowed.
When asked about Moderna’s proposal, a White House spokesman said Monday that “all options are on the table.”
Prashant Yadav, who studies health care supply chains with the Center for Global Development in Washington, said Moderna might be able to manufacture more of its vaccine “relatively quickly” if given the green light to add doses in each vial.
But he said it wouldn’t be an instant change. “I don’t think Moderna has a surplus,” he says.
Mr. Yadav said the finishing and filling process is intensely automated, dedicated to avoiding contamination and accurate to the microgram. At maximum speed, up to 1,000 vaccine vials can be filled per minute, he said.
He said a 15-dose vial comes with a trade-off: it could lead to more wasted doses if the healthcare professional ran out of people to vaccinate and had to throw away the rest of the doses. But in the midst of a raging pandemic, experts have said, it may well be a risk federal health officials are willing to take.
[ad_2]
Source link