Pfizer, Moderna and Johnson & Johnson execs say they're working all the angles on increasing COVID-19 vaccine production and expect to amp up weekly deliveries by tens of millions by the end of March.
Pfizer, which has been shipping 4 million to 5 million doses per week, plans to increase that to 13 million a week by mid-March, according to executive testimony planned for Tuesday morning's hearing before the House Energy and Commerce Committee's oversight arm.
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 wins FDA authorization as expected, Richard Nettles, M.D., vice president of U.S. medical affairs at Janssen’s infectious diseases and vaccines unit, said in his testimony. The shot is up for an FDA panel review later this week.
And Moderna, which 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, president Stephen Hoge's testimony states.
Moderna is well on its way to wrapping up three 100-million-dose pledges by the end of March, May and July, respectively, Hoge added. To hit 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,” Hoge said, citing fill-finish as an especially tricky hurdle.
CDMO Catalent currently tackles filling work for Moderna’s shot at its biologics facility in Bloomington, Indiana, and also inspects and packages filled vials for delivery. Meanwhile, Moderna is signing on an additional fill-finish partner in the U.S. to boost capacity.
Moderna also hopes to increase the number of doses in its vaccine vials, which are currently cleared 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 both speed up manufacturing runs and cut the need for high-demand consumable materials, Hoge said.
As of February 17, Pfizer had delivered some 40 million doses of its rival mRNA vaccine, Chief Business Officer John Young said in his prepared testimony. Pfizer and its German partner BioNTech have ramped up production and pledged to turn out at least 2 billion doses of their shot, Comirnaty, by year-end.
The company has pumped investments into its facilities in Saint Louis, Missouri; Andover, Massachusetts; Kalamazoo, Michigan; and Pleasant Prairie, Wisconsin. That’s in addition to new lines at the company’s McPherson, Kansas, site, and a lipid production start in Groton, Connecticut, Young said.
With that, Pfizer figures it can make good on its promise to ready 120 million doses for the U.S. by the end of March, followed by another 80 million doses in May, and expects to ship all 300 doses it’s committed by the end of July.
Meanwhile, Johnson & Johnson, whose single-dose adenovirus virus shot is up for an FDA advisory committee vote on Friday, is “working around the clock” to scale production in the U.S., Nettles said.
The company aims to deliver 20 million doses by the end of March if the shot wins FDA clearance. J&J says it will provide a total of 100 million in the first half of the year. The company is “continuing to partner with the U.S. government to explore all options to accelerate delivery,” Nettles added.
J&J started prepping its facility in the Netherlands for vaccine production last July, and since then, the company has hustled to beef up its own production muscle and sign contract manufacturers, Nettles said, adding that it plans to have seven COVID-19 vaccine manufacturing sites up and running by midyear.
The manufacturing process for Johnson & Johnson broadly breaks down into two steps: drug substance manufacturing and drug product manufacturing. Producing drug substance—which involves growing the necessary biological cells and then purifying the active vaccine—takes about two months, Nettles said.
It then takes another five to six weeks to produce, test and release the shots—work that will be done in Europe, Asia, Africa and at U.S. sites in Indiana, Pennsylvania and Michigan. Regulatory inspections for specialized equipment used in this step of the manufacturing process are also underway, Nettles said.
While a clinical trial setback last year slowed J&J's journey to the finish line, its shot still has a major role to play in vaccination efforts in the U.S. and beyond, analysts figure. In a note to clients, Cantor Fitzgerald wrote last week that the single-dose shot "has perfect characteristics to potentially make the product the most desirable vaccine in countries which have a less sophisticated supply chain than the U.S."
Namely, the shot's one-and-done dosing regimen would make administration easier; plus, Johnson & Johnson's shot can be stored at standard fridge temperatures of 36 degrees to 46 degrees Fahrenheit, bypassing the stringent cold chain requirements of Pfizer and Moderna's mRNA vaccines.
Editor's note: This story has been corrected to reflect that Catalent fills and packages Moderna's vaccine at its Bloomington plant.