Moderna (MRNA) is expanding both its in-house and partner COVID-19 vaccine production capabilities, putting its 2022 production target at 1.4 billion doses.
The new goal, announced Wednesday, is nearly triple the original half-billion goal it set last year. The company has increased its 2021 target to 700 million, but hopes it can produce as many as 1 billion doses this year. Moderna also recently said it would double its output for the U.S. government by April, noting that it has already shipped 55 million doses to date.
Moderna CEO Stéphane Bancel told Yahoo Finance that demand for the company's vaccine, which has among the highest efficacy rates globally, prompted the ramp up. In addition, the federal government stated that there will be a need to produce COVID-19 vaccines beyond this year.
Moderna currently partners with Swiss-based Lonza to manufacture its vaccine and with NJ-based Catalent (CTLT) to fill and finish the vaccine doses. It also has several key suppliers of specialized raw material, such as lipid nanoparticles, which are used to help deliver the vaccine formula.
As a result of the the newness of the mRNA platform, used in both the Moderna and Pfizer (PFE) vaccines, production hit some bottlenecks due to the unprecedented demand. Only a handful of companies had some of the necessary items, and suppliers of more generic vaccine equipment and supplies were squeezed by the global demand — especially with vaccine production efforts also in Europe and Asia.
Bancel said that for the company's part, it paid raw material suppliers upfront in cash, which in turn helped them buy equipment and increase their hiring.
The suppliers were worried that if the vaccine fails in the clinical trials, "you might go bankrupt and not pay us," Bancel said.
The White House invoked the Defense Production Act (DPA) under the Trump administration to help Moderna get priority rating for any needed supplies and equipment.
White House COVID-19 Response Team supply-chain coordinator Tim Manning said on February 5 that the priority rating means that vaccine manufacturers can get access first to whatever they need.
During a U.S. House Energy and Commerce subcommittee hearing this week, officials from leading COVID-19 vaccine companies told lawmakers they expect manufacturing to run more smoothly now that many bottlenecks have been addressed. Moderna's president, Stephen Hoge, said the company is "still learning" how to scale up the new technology, but that it is on track to meet its expedited timeline of 300 million doses in total to the U.S. by July.
Moderna is expanding production as a result of talks with federal officials indicating that the need for COVID-19 vaccines will be long-term. And the expansion will also allow the company to have more flexibility in the production of potential variant-specific booster shots.
That includes the booster targeting B.1.351, the variant which originated in South Africa, that is being submitted to the National Institutes of Health for clinical studies, the company announced separately Wednesday.
The company plans to test the booster, at 50 micrograms — or half the current dose— as well as a combination of the existing and booster shot, and a separate test of half the current dose alone as a booster. The three studies will show which option has stronger efficacy results, and the company would seek regulatory approval once the data is in.
"We expect our additional capital investments to drive our capacity to 1.4 billion doses for 2022, assuming the current 100 microgram dose. If our variant vaccine booster requires a lower dose, such as 50 micrograms, we could have more than 2 billion doses of capacity for 2022," Bancel said.
But even with the expansion plans, the real impact won't be felt until 2022.
"Given a six- to nine-month timeframe to add capacity and an additional timeframe to permit regulatory validation and ramp-up, it is estimated that up to 12 months may be necessary before the additional production is available," the company said in a statement.
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