Pfizer, Moderna and Johnson & Johnson executives say they are working every angle to increase COVID-19 vaccine production and expect to increase weekly deliveries by tens of millions by the end of March.
Pfizer, which has sent between 4 and 5 million doses per week, plans to increase it to 13 million a week by mid-March, according to the executive witness scheduled for Tuesday morning’s hearing in front of the oversight of the House Energy and Commerce Committee.
J&J, which reportedly only had 2 million doses in stock last week, should be able to ship 20 million by March 31, as long as it gets FDA approval as expected, Richard Nettles, MD, vice president of US Medical Matters to Infectious Diseases and Janssen Vaccines unity, he said in his testimony. The plan is scheduled for a review by the FDA panel 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 its monthly deliveries by April, according to the witness of President Stephen Hoge.
Hoge has advanced that Moderna is on track to finish three promises of 100 million doses by the end of March, May and July, respectively. To achieve this goal, the company “continuously learns and works closely with our partners and the federal government to identify ways to address bottlenecks and accelerate our production,” said Hoge, who cited the process of filling as an especially complicated obstacle.
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CDMO Catalent is currently working on the modernization of Moderna’s shot at its biological facility in Bloomington, Indiana, while Moderna itself inspects, tests and packs the filled vials to deliver them. That could change soon, as Moderna signs an additional filler finishing partner in the United States to increase capacity and complement the company’s own packaging and testing processes.
Moderna also hopes to increase the number of doses in its vaccine vials, which are currently authorized to maintain 10. The FDA has offered “positive feedback” on Moderna’s effort to include up to 15 doses per vial, a movement that would accelerate manufacturing. it works and reduces the need for high-demand consumables, Hoge said.
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As of Feb. 17, Pfizer had administered 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 pledged to produce at least two billion doses of their shot, Comirnaty, by the end of the year.
The company has boosted investment in its Saint Louis, Missouri facility; Andover, Massachusetts; Kalamazoo, Michigan; and Pleasant Prairie, Wisconsin. This adds to the new lines at the company’s McPherson, Kansas site, and a start of lipid production in Groton, Connecticut, Young said.
With that, Pfizer estimates it can deliver on its promise to prepare 120 million doses for the United States by the end of March, followed by 80 million more doses in May, and expects to ship the 300 doses it has committed by the end of July.
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Meanwhile, Johnson & Johnson, whose single-dose adenovirus virus is scheduled for an FDA advisory committee vote Friday, “works all day” to scale production in the U.S., Nettles said.
The company plans to administer 20 million doses by the end of March if the shot gets FDA approval. J&J says it will provide a total of $ 100 million during the first half of the year. The company “continues to work with the U.S. government to explore all options to expedite delivery,” Nettles added.
J&J began preparing its facilities in the Netherlands for vaccine production last July and since then the company has been quick to strengthen its own production muscle and sign manufacturers by contract. say Nettles, adding that he plans to have seven COVID-19 vaccine manufacturing centers. in operation in the middle of the year.
The Johnson & Johnson manufacturing process is divided into two phases: pharmaceutical manufacturing and pharmaceutical manufacturing. The production of a pharmacological substance — which involves culturing 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 launch the plans, work that will be done in Europe, Asia, Africa, and in U.S. locations in Indiana, Pennsylvania, and Michigan. Nettles has also conducted regulatory inspections of specialized equipment used in this step of the manufacturing process.
While a reversal of clinical trials last year slowed J&J’s journey toward the goal, his shot still plays an important role in vaccination efforts in the U.S. and beyond, analysts say. In a note to customers, Cantor Fitzgerald wrote last week that the single-dose shot “has perfect characteristics to potentially make the product the most desirable vaccine in countries with a less sophisticated supply chain than the U.S.”
That is, the complete dosing regimen of the shot will facilitate administration; in addition, the Johnson & Johnson shot can be stored at a standard refrigerator temperature of 36 to 46 degrees Fahrenheit, bypassing the strict cold chain requirements of Pfizer and Moderna mRNA vaccines.