Executives at Pfizer, Moderna, and Johnson & Johnson say they are working from all angles to increase production of the COVID-19 vaccine and expect to increase weekly deliveries by the tens of millions by the end of March.
Pfizer, which has been shipping 4-5 million doses per week, plans to increase that to 13 million per week by mid-March, according to executive testimony planned for Tuesday morning’s hearing before the oversight arm of the Committee on Energy and Commerce of the Chamber.
J&J, which reportedly had just 2 million doses in stock last week, should be able to ship 20 million by March 31, provided it gets FDA clearance as expected, Richard Nettles, MD, US vice president of medical affairs. In infectious diseases and vaccines Janssen unit said in his testimony. The vaccine is ready for an FDA panel review later this week.
And Moderna, which has already doubled its monthly deliveries to the feds this year and has so far supplied 45 million doses of its mRNA vaccine, aims to double monthly deliveries again by April, states President Stephen Hoge’s testimony.
Moderna is on track to deliver on three promises of 100 million doses by the end of March, May and July, respectively, Hoge added. To achieve that goal, the company is “continually learning and working closely with our partners and the federal government to identify ways to address bottlenecks and accelerate our production,” said Hoge, citing filling and finishing as an obstacle. especially complicated.
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CDMO Catalent is currently addressing the filling work for Moderna’s injection at its biological facility in Bloomington, Indiana, while Moderna inspects, tests and packages the filled vials for delivery. That could change soon, as Moderna signs an additional filling and finishing partner in the US to increase capacity and complement the company’s own testing and packaging processes.
Moderna also hopes to increase the number of doses in its vaccine vials, which are currently approved to hold 10. The FDA has offered “positive feedback” on Moderna’s effort to include up to 15 doses per vial, a move that would speed manufacturing. it works and reduces the need for high-demand consumables, Hoge said.
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As of February 17, Pfizer had delivered about 40 million doses of its rival mRNA vaccine, said commercial director John Young in his prepared testimony. Pfizer and its German partner BioNTech have increased production and are committed to producing at least 2 billion doses of their injection, Comirnaty, by the end of the year.
The company has invested in its Saint Louis, Missouri facility; Andover, Massachusetts; Kalamazoo, Michigan; and Pleasant Prairie, Wisconsin. That is in addition to new lines at the company’s site in McPherson, Kansas, and a lipid production start in Groton, Connecticut, Young said.
With that, Pfizer calculates that it can fulfill its promise to prepare 120 million doses for the US by the end of March, followed by another 80 million doses in May, and expects to ship the 300 committed doses by the end of July.
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Meanwhile, Johnson & Johnson, whose single-dose adenovirus vaccine will be voted on by the FDA advisory committee on Friday, is “working around the clock” to scale production in the United States, Nettles said.
The company aims to deliver 20 million doses by the end of March if the injection gets FDA approval. J&J says it will provide a total of 100 million in the first half of the year. The company “continues to partner with the US government to explore all options to expedite delivery,” Nettles added.
J&J began preparing its facility in the Netherlands for vaccine production last July, and since then the company has been quick to build its own production muscle and sign contract manufacturers, Nettles said, adding that it plans to have seven COVID-19 vaccine manufacturing sites. in operation in the middle of the year.
Johnson & Johnson’s manufacturing process is divided into two steps: manufacturing of pharmaceuticals and manufacturing of pharmaceuticals. Production of the drug substance, which involves growing the necessary biological cells and then purifying the active vaccine, takes about two months, Nettles said.
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Then it takes another five to six weeks to produce, test and release the shots, work to be done in Europe, Asia, Africa, and at the US sites in Indiana, Pennsylvania and Michigan. Regulatory inspections are also underway for specialized equipment used in this step of the manufacturing process, Nettles said.
While a setback in a clinical trial last year slowed J & J’s journey to the finish line, his injection still has an important role to play in vaccination efforts in the U.S. and beyond, analysts estimate. . In a note to clients, Cantor Fitzgerald wrote last week that the single-dose injection “has perfect characteristics to potentially make the product the most desirable vaccine in countries that have a less sophisticated supply chain than the US.”
That is, the single injection dosage regimen would facilitate administration; Additionally, the Johnson & Johnson injection can be stored at standard refrigerator temperatures of 36 degrees to 46 degrees Fahrenheit, avoiding the strict cold chain requirements of Pfizer and Moderna mRNA vaccines.