Moderna and its partners in the federal government are just now gearing up for a late-stage COVID-19 vaccine trial set to launch later this month, but at the same time, the mRNA biotech is prepping a supply of doses for quick shipment if the shot gets an FDA go-ahead.
On a conference call detailing positive phase 1 data for mRNA-1273, the company’s COVID-19 vaccine, Moderna CEO Stéphane Bancel said the company has “already started to make commercial product at risk and will continue to do so every day, every week, every month.”
The company and its partners are working to produce millions of doses at three sites for the U.S. market, Bancel said. Moderna itself is turning out vaccine supplies for the U.S. market at its site in Massachusetts and in conjunction with partner Lonza, which is producing supplies in New Hampshire, Bancel said. Catalent will handle fill and finish duties in Indiana.
The company believes it can produce 500 million doses to 1 billion doses annually, and has set out to make enough product “to be able to vaccinate everybody in the U.S.,” Bancel said.
As for distribution, which poses its own challenges during a pandemic, Bancel said a partnership with the government would be “very important" under an emergency authorization from the FDA. The government, not a company, should prioritize early shipments and decide who gets the first vaccinations, he told analysts. Early on, Bancel expects “very tight supply,” while “traditional channels” of distribution would take over after some time.
Moderna late Tuesday posted phase 1 data showing the vaccine candidate elicited a “robust" immune response across all dose levels in all patients, with no serious side effects. With the results, the company is gearing up for a randomized phase 3 study in 30,000 participants set to launch later this month.
The new data, and phase 3 trial preparations, raised hopes that a vaccine could be available later this year or early next year, which is the stated goal of the United States’ Operation Warp Speed program. But even as Moderna and other frontrunners race ahead, Merck CEO Ken Frazier issued a word of caution.
In a June 30 interview with Tsedal Neeley, the Naylor Fitzhugh Professor of Business Administration at Harvard Business School, Frazier said COVID-19 vaccine hype could actually be hurting the pandemic response as it allows the public to ignore common-sense measures to slow the spread of COVID-19. Historically, vaccines have taken several years or longer to develop, Frazier said.