Global coronavirus vaccine makers have been rolling out details about their manufacturing and launch plans—even ahead of any clinical data. Now, Pfizer says it will draw on three sites in the U.S., plus one in Belgium, for the early stages of a launch, provided its BioNTech-partnered shot wins a green light.
Pfizer plans to draw on sites in Kalamazoo, Michigan, and Andover, Massachusetts, as well as St. Louis for the early stages of its mRNA vaccine ramp-up. The company is in human testing with four candidates alongside partner BioNTech, which will supply doses for clinical testing.
The company plans raw material manufacturing in St. Louis and drug substance manufacturing in Andover. The Kalamazoo site is slated to handle formulation and filling.
Aside from Pfizer's U.S. sites, the drugmaker has identified a plant in Puurs, Belgium, as a COVID-19 vaccine manufacturing center. The company plans to select other sites as well. For its part, BioNTech intends to add capacity at two of its facilities in Germany.
Pfizer believes it can deliver millions of doses by the end of 2020—which would be a remarkable accomplishment—and then deliver hundreds of millions in 2021.
Even though the partners just entered human testing and haven't reported any data, Pfizer employees are taking steps to prepare for the possible rollout now.
Those include exchanging technology to plan the manufacturing process, ordering materials, preparing “parallel” supply chains and hiring new staff. Like other companies, Pfizer is doing the work “at risk,” or before the vaccine demonstrates efficacy, to cut crucial time it would take to launch if the data turn out positive.
In response to the news, Michigan Gov. Gretchen Whitmer said in a statement that she's "so proud that one of the largest pharmaceutical manufacturing facilities in the world is the Pfizer site right here in Kalamazoo," citing how global supply chains have hindered the U.S. COVID-19 response.
Pfizer isn’t alone in planning for a massive COVID-19 vaccine ramp-up. Part of the reason Sanofi and GlaxoSmithKline entered their unprecedented tie-up was to combine scale for a massive rollout in 2021. Those companies, plus Pfizer and Merck & Co., are the largest vaccine players in the world.
Johnson & Johnson, meanwhile, has struck multiple manufacturing deals for its own COVID-19 vaccine program with plans to produce more than 1 billion doses. The New Jersey drugmaker’s deal with Emergent BioSolutions was intended to ensure U.S. production for early batches, The New York Times reported. J&J has also signed a deal with Catalent.
Meanwhile, AstraZeneca has signed on to produce and distribute vaccines for the University of Oxford's promising program, which is speeding ahead.
And Moderna, which has one of the most advanced COVID-19 vaccine projects, has signed a manufacturing deal with Lonza for up to a billion doses per year. Moderna on Thursday said it has received FDA approval to enter phase 2 testing and is planning phase 3 testing in the "early summer."