COVID-19 Stresses Manufacturing Capacities and Funders’ Understanding

The race toward a COVID-19 vaccine is focused around scientific development right now, but companies also need to be planning for manufacturing.

This is a race of “virus vs. humans,” John Markels, president, global vaccines for Merck, said during a panel discussion at BIO 2020. “It’s the scientific and global health challenge or our generation, and it demands cooperation across our industry.”

“Vaccination is the only exit strategy,” said panel moderator Amanda Glassman, CEO of the Center for Global Development.

If that’s accurate, billions of people need vaccination. To that end, regulatory bodies around the world are harmonizing regulations. The biopharma industry is scrambling, too, using existing vaccine platforms to target the SARS-CoV-2 virus (and thus leverage production facilities) and pulling out all the stops to find manufacturing capacity.

Manufacturing capacity is a critical issue. Even before the pandemic, vaccine production was near capacity. Building a facility typically takes about three years, and planning begins only after proof of concept because the risk of failure is high. In the midst of a pandemic, however, companies lack that luxury. They are arranging manufacturing before they have all the scientific data.

“You can’t wait to have clinical data,” Stephane Bancel, CEO of Moderna, stressed. Instead, companies must accept the risk now. He started early, approaching large foundations and governments for help developing the necessary manufacturing.

“I even went to the World Bank. They all said it was too risky,” he recalled. “So, I went to the public market to raise $1 billion for manufacturing and vaccine stockpiling.” The company got to clinical trials in record speed and expects to produce 100 million doses this year and one billion in 2021. “The worst thing for the world is to have only a few million doses of a vaccine at the end of the year.

Moderna partners with Lonza, a leading contract manufacturing organization, in its bid to develop one billion doses in 2021.

“We needed GMP space, equipment, materials and trained people,” Bancel said.

To broaden the coverage and spread its risk, Moderna works with Lonza’s U.S. plant for tech transfer and a Swiss site for additional manufacturing, and is discussing a site in Singapore. Bancel said his greatest concern now was access to enough raw materials.

With more than 200 vaccines currently in development, “There will be pressure on raw materials,” Richard Hatchett, M.D., CEO, Coalition for Epidemic Preparedness Innovation (CEPI), said. He noted a shortage of glass vials, but other shortages are likely if many of these candidates are scaled up.

“The scale of development takes people out of their comfort zones,” Hatchett continued. “Ministers of health normally would be happy to vaccinate 300 million people. Now they’re looking at 3 to 5 billion, globally. Those are numbers they aren’t used to seeing and it’s hard for them to wrap their heads around it. Therefore, we need to make smart choices in terms of paring vaccine developers with manufacturing capacity.”

There also are concerns that the countries developing the vaccines will look to their own needs first and neglect poorer nations. Peter Marks, M.D., PhD, director, Center for Biologics Evaluation and Research, United States Food and Drug Administration (FDA), disagreed.

“Everyone realizes this is a global problem,” Marks said. “I think it will be like the oxygen masks on airplanes. You put on your own mask first, and then help others. As we make progress (on a vaccine), we want to share it as quickly as possible.”

To increase equitable access, some panelists proposed encouraging countries to self-procure vaccines by buying into a portfolio of vaccines. The most successful in that pool will flow into the manufacturing facility, where they will be available to those funding this pool. They suggested this would not only improve access to COVID-19 vaccines, but also provide funding to help promising vaccines advance.

As vaccines are rolled out, it will be important to know and explain which groups will get the vaccine first, and why, Vivien Tsu, Ph.D., clinical professor, global health, University of Washington, added. “We need to start working on this now and training healthcare workers so they can test these messages with communities.” Otherwise, mistrust of the healthcare system will increase. She also advocated for monitoring rumors, myths and misconceptions on social media.

Looking beyond this pandemic, panelists called on the biopharma industry to use the efforts being made today to put them in a better position for subsequent healthcare crises. “We need to be better prepared in the future,” Markels said. He defined that as being in a position to work together as a global society.

To Hackett, that means understanding the value of collective coordination and collaboration, and leaving some of the mechanisms developed for this pandemic in place. As numerous panelists pointed out throughout multiple sessions, “We’re all in this together.”