As Moderna seems to be to extend the doses in vaccine vials, the White Home publicizes an anticipated increase in manufacturing.
Up-and-coming drug maker Moderna is calling on U.S. regulators to increase the amount of coronavirus vaccine put in each vial by up to 50 percent, arguing that it can speed up vaccination of patients by removing a simple manufacturing bottleneck: drugs in Fill bottles.
The Food and Drug Administration could decide within a few weeks how much more vaccine Moderna, the developer of one of the two state-approved Covid-19 vaccines, can put in its vials. According to Moderna, the number of doses per vial can be increased from 10 up to 15.
The company has already ramped up production of its vaccine only to find a bottleneck in filling, capping and labeling. With FDA approval, more doses could quickly get into each bottle. This is a welcome boost to the campaign to contain a pandemic that killed more than 440,000 people in the US alone. In a statement late Monday, Ray Jordan, a Moderna spokesman, said limiting the dosage per vial was limiting the production of Moderna.
The Moderna proposal is part of a broader effort by the Biden government to accelerate vaccine distribution, including removing barriers to the “fill and finish” phase of manufacturing. Although the nuts and bolts stage has received less attention than vaccine development, it has been identified for years as a limitation on vaccine production.
On Tuesday, Jeffrey D. Zients, the White House’s Covid-19 response coordinator, announced that the federal government would allocate at least 10.5 million doses of coronavirus vaccines to states for the next three weeks, an expected increase of five percent Increase in manufacturing.
At a press conference in the White House, Zients presented the increase in doses as an achievement of the Biden government and said: “We have increased the supply by more than 20 percent since we took office.” The increase in production has long been expected, however, as the companies that make two government-approved vaccines, one from Pfizer and BioNTech and one from Moderna, stepped up their efforts. Last week, companies increased their supply to the US by 16 percent.
Governors were notified of the increase on a call Tuesday morning to give them more time to schedule vaccinations, Zients said with three weeks notice for new allocation numbers – a cornerstone of a new effort by the Biden government to improve a distribution system that immersed in uncertainty and confusion over limited supply and unused doses.
“This allows them to plan accordingly and know which employees they need to have,” he said. “I think historically there have been fluctuations. We are very prepared not to have this fluctuation. “
Moderna has discussed the possible change in the number of doses in vials with the FDA but has not yet provided manufacturing data to support it. Federal regulators may be receptive to the idea of more doses in each vial, but may oppose the idea of a 50 percent increase.
The industry standard has long been 10 doses per vial, and federal regulators may fear that the extra punctures of the vial’s rubber cover and the time it takes to extract more doses increases the risk of bacterial contamination of the vaccine could increase. Moderna’s proposal to the FDA to increase the dose was first reported by CNBC.
Packing more vaccine in each Moderna vial is one of several options the White House and health officials are considering to ramp up production before spring, when authorities expect a renewed spike in infections from emerging variants of the virus.
The manufacturer of the other federally approved vaccine, Pfizer, cannot increase the amount of vaccine in its vials because its manufacture is geared towards a specific vial size that can only hold about six doses. But Moderna’s bottle is big enough to hold more than the 10 doses now allowed.
When asked about Moderna’s proposal, a White House spokesman said Monday that “all options are on the table”.
Among other things, Mr. Zients said that the government has now arranged for special syringes with Pfizer’s vials to be sent so that practitioners can extract a sixth dose. Dr. Albert Bourla, CEO of Pfizer, told investors Tuesday that the company was now two months ahead of schedule and would deliver a total of 200 million cans to Americans by the end of May instead of the end of July. The acceleration is at least partially due to the government’s decision to count the Pfizer vial as six doses instead of five.
Prashant Yadav, who studies healthcare supply chains at the Washington Center for Global Development, said Moderna could potentially make more of its vaccine “relatively quickly” if it were given the green light to add doses to each vial.
But he said it wasn’t an instant change. “I don’t think Moderna has a surplus,” he said.
Mr. Yadav said the finish-and-fill process is highly automated, dedicated to deterring contamination, and accurate to the microgram. It can fill up to 1,000 vaccine bottles per minute at top speed, he said.
He said that having a 15-dose vial involves a compromise: if healthcare professionals run out of people to get vaccinated and the rest of the doses have to be thrown away, it could lead to more wasted doses. But amid a raging pandemic, experts say, that could be a risk federal health officials would take.