The new modern pharmaceutical company is asking US regulators to increase the amount of coronavirus vaccine placed in each vial by up to 50 percent, arguing that it can speed up vaccines for patients by eliminating a simple manufacturing bottleneck: placing the drug in bottles.
The Food and Drug Administration may decide within a few weeks how much more Modern vaccine, the developer of one of the two Covid-19 vaccines authorized by the federal government, can put in their vials. Moderna says it can increase the number of doses per bottle from 10 to up to 15.
The company is already increasing the production of its vaccine, only to find a bottleneck in the bottling, capping and labeling process. With FDA approval, more doses can start to go to each bottle quickly, a welcome boost to the campaign to contain a pandemic that has killed more than 440,000 people in the United States alone. In a statement on Monday, Ray Jordan, a spokeswoman for Moderna, said the restriction on dosing per bottle was limiting Moderna’s production.
Moderna’s proposal is part of a broader push by the Biden government to accelerate the distribution of the vaccine, including removing obstacles in the “fill and finish” manufacturing phase. Although the stage of nuts and bolts receives less attention than vaccine development, it has been identified for years as a restriction on vaccine production.
On Tuesday, Jeffrey D. Zients, Covid-19 White House response coordinator, said the federal government would allocate a minimum of 10.5 million doses of coronavirus vaccines to states in the next three weeks, a a five percent increase resulting from an expected increase in manufacturing.
At a press conference at the White House, Zients framed the dose increase as an achievement by the Biden government, saying “we have increased supplies by more than 20 percent since we took office.” But the increase in production has been expected for a long time, as companies that manufacture two vaccines authorized by the federal government, one from Pfizer and BioNTech and the other from Moderna, have stepped up their efforts. Last week, companies increased their supply to the US by 16%.
Governors were informed of the increase in a call on Tuesday morning to give them more time to plan vaccinations, said Zients, with three weeks notice for new allocation numbers – a cornerstone of a new government effort Biden to improve a distribution system mired in uncertainty and confusion about limited supply and unused doses.
“This allows them to plan properly and know what personnel they will have,” he said. “I think that, historically, there has been fluctuation. We are very attuned to not having this fluctuation. “
Moderna discussed the possible change in the number of doses in vials with the FDA, but has yet to provide manufacturing data to support it, said people familiar with the discussions. Federal regulators may be receptive to the idea of more doses in each bottle, but they may hesitate at the idea of a 50% increase.
The industry standard has long been 10 doses per bottle, and federal regulators may be concerned that extra punctures through the needles of the bottle’s rubber cover and the time needed to extract more doses may increase the risk of contamination of the vaccine with bacteria . Moderna’s proposal to the FDA to increase the dose was first reported by CNBC.
Putting more vaccine into each vial of Moderna is one of several options that the White House and health officials are exploring as they push to expand production before spring, when authorities expect a new outbreak of infections from emerging variants of the virus .
The manufacturer of the other federally approved vaccine, Pfizer, is unable to increase the amount of vaccine in its vials because its manufacture is aimed at a specific vial size that can contain only about six doses. But the Moderna bottle is large enough to hold more than the 10 doses allowed now.
Asked about Moderna’s proposal, a White House spokesman said on Monday that “all options are on the table”.
Among other efforts, Mr. Zients said the government had now ensured that specialized syringes were sent with Pfizer vials so that doctors could extract a sixth dose from them. Dr. Albert Bourla, chief executive of Pfizer, told investors on Tuesday that the company was now two months ahead and hoped to deliver a total of 200 million doses to Americans by the end of May, instead of the end July. The acceleration is at least in part because the government decided to count the Pfizer bottle as six doses instead of five.
Prashant Yadav, who studies health supply chains with the Center for Global Development in Washington, said Moderna may be able to “relatively quickly” make more of its vaccine if it gets the green light to add doses to each vial.
But he said it would not be an instant change. “I don’t think Moderna has a surplus out there,” he said.
Yadav said that the finishing and filling process is intensely automated, dedicated to avoid contamination and accurate for the microgram. At full speed, up to 1,000 vials of vaccine can be filled per minute, he said.
He said that a bottle of 15 doses has a disadvantage: it can lead to more missed doses if the health professional runs out of people to be inoculated and has to discard the rest of the doses. But in the midst of a violent pandemic, experts said, this could be a risk that federal health officials would be willing to take.