Pfizer to nearly halve COVID-19 vaccine production timeline, sterile injectables VP says

With an upsized production goal of 2 billion COVID-19 vaccine doses this year, Pfizer and its German partner BioNTech aren’t resting on their laurels now that their shot, Comirnaty, has emergency nods in the U.S., Europe and beyond. As the companies continue to build out capacity, manufacturing efficiency is getting its own boost, Pfizer revealed. 

The time it takes the company to produce a COVID-19 vaccine batch could soon be cut from 110 days to an average of just 60, Chaz Calitri, vice president of sterile injectables, told USA Today. “We call this ‘Project Light Speed,’ and it’s called that for a reason,” he said. “Just in the last month, we’ve doubled output.”

One element teed up for acceleration is DNA production—the first step in Pfizer’s vaccine manufacturing process, Calitri explained. Making that DNA originally took 16 days, but the process will soon take just nine or 10 days, he said.

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Production efficiencies aside, the company is also looking to dial up capacity with the addition of new manufacturing lines at all three of its U.S. plants, USA Today said. Demand for a functional shot meant Pfizer didn’t have the span of several years typically required to refine its manufacturing process, so the company is improving as it goes, Calitri noted. “We just went straight into commercial production," he said.

Engineers took an eye to improving manufacturing the moment vials started coming off production lines, which led the company to make “a lot of really slick enhancements,” he added.

A Pfizer spokesperson confirmed Calitri’s comments to Fierce Pharma via email.

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Pfizer and BioNTech’s manufacturing network depends on six facilities split between Europe and the U.S. Stateside, the vaccine starts its life at Pfizer’s Chesterfield, Missouri, plant, where the DNA is produced. It then heads to the company’s facility in Andover, Massachusetts, for transcription into mRNA, before finally making its way to Kalamazoo, Michigan for fill-finish—with lipid and lipid nanoparticle production and formulation taking place somewhere prior to that final step. Calitri heads up operations at the Kalamazoo plant.

Pfizer and BioNTech’s mRNA-based vaccine last year became the first COVID-19 shot authorized in Europe and the U.S. On deck to supply hundreds of millions of doses to those two regions alone, BioNTech’s CEO Uğur Şahin recently said the companies would boost their 2021 output target to 2 billion doses from a prior goal of 1.3 billion.

At the time, Şahin pinned those production hopes on six global manufacturing sites tapped in the companies’ alliance, including a facility in Marburg, Germany, that he said was expected to go live by the end of February.

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A little more than a week later, the biotech won approval to start manufacturing its vaccine at the Marburg site, which employs 300 people and is set to produce up to 750 million doses annually, German news outlet Hessenschau reported.

The announcement ran up against news that BioNTech was carrying out a factory upgrade in Puurs, Belgium that would allow it to deliver “significantly more doses in the second quarter”—though that production boost came with a catch: namely, “a short-term disruption of supply” in Europe, Canada and a few other countries.

Meanwhile, in a sign of the unconventional alliances COVID-19 has fostered, Pfizer and BioNTech recently got some added manufacturing muscle from two Big Pharma rivals. Sanofi in late January said it would produce more than 100 million Comirnaty doses in Europe in 2021, with the first deliveries from its site in Frankfurt, Germany, expected by August, a company spokesperson told Fierce Pharma.

Just a few days later, Swiss drugmaker Novartis said it would pitch in, too, agreeing to carry out fill-finish work at its facility in Stein, Switzerland, where production is pegged to start in the second quarter.