BIO: Moderna, Merck execs see possible speed bumps in COVID-19 vaccine manufacturing

Moderna manufacturing site
Moderna is a COVID-19 vaccine front-runner, and the U.S. federal government is planning a phase 3 trial next month. (Moderna)

With more than 130 vaccines against COVID-19 under development, headlines highlighting their progress swirl at a dizzying pace. But behind the scenes, execs at some of the leading players are intensely focused on the details needed to produce the candidates on a massive scale.

For instance? Sourcing raw materials and assembling the labor force needed to produce hundreds of millions of shots in record time, execs for Moderna and Merck said at BIO’s digital conference this week.  

When Moderna started its vaccine program earlier this year, the company anticipated making about 100 million vaccine doses per year, CEO Stéphane Bancel said during a BIO virtual panel on vaccine manufacturing. That’s a “pretty good volume” for most vaccines but “very tiny” compared to the global need amid the current pandemic, he added.

In Moderna’s push to further scale up in conjunction with partner Lonza, Bancel outlined four requirements: manufacturing space, equipment, raw materials and people. With its Lonza partnership, the company is able to scale up its infrastructure, but Bancel still worries about materials, he said during the panel.

The CEO believes Moderna and Lonza can get their hands on supplies, but he anticipates a “bumpy” path. The materials come from China, Eastern Europe, Switzerland and the U.S., he said.

“I’ve never seen such a scale-up that wasn’t bumpy,” Bancel said.

RELATED: Moderna aims for a billion COVID-19 shots a year with Lonza manufacturing tie-up

Meanwhile, Merck’s vaccine president John Markels said he's concerned about staffing. Companies can build factories, but there’s a limited number of talented people to run the procedures, he said.

“There are a number of really good manufacturing vaccinologists out there, [such as] scientists and biochemical engineers, but it’s not unlimited,” Markels said. “Ultimately, I think you can build pipes, plants, factories, stirrers, mixers and freezers, but if you don’t have the people who can make it work, you run into trouble.”

Industrywide, Markels talked about the “kitchen sink” approach to scaling up COVID-19 vaccine manufacturing.  

“Everyone is trying to do whatever they can with existing facilities, with older facilities that can be retrofitted, with manufacturing partners” to try to find capacity, he said. In many cases, companies are building out factories based on mere predictions about what they’ll need.

Vaccine manufacturing itself is a “very intensive” process with “scores of steps” and “thousands of samples and tests that have to be validated and precise,” he added. Normally, companies develop their manufacturing process over years, but for COVID-19, it’s being shortened to months. The “good news,” though, is that much of the work is already happening, Markels said.

RELATED: Moderna, AstraZeneca and J&J coronavirus shots rev up for NIH tests beginning in July: WSJ

Still, the Merck exec cautioned that there won’t be nearly enough global capacity to make all of the candidates in development, so it’ll take a collaborative approach to select the best options for manufacturing. Plus, the first “process and product” to reach the market might not be the “final process and product.”

And while companies work through their manufacturing concerns, another expert outlined the need for a COVID-19 vaccine education and awareness push ahead of any immunization campaign.

“If we don’t have communities ready to accept [the vaccine] and trust it, that work is going to be for naught,” said Vivien Tsu, a clinical professor of global health at the University of Washington.

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