How Moderna is Taking on the Pharma Giants With its COVID-19 Vaccine
As some of the world’s largest drugmakers gear up to manufacture and distribute COVID-19 vaccines, a relatively tiny competitor, Massachusetts-based Moderna, faces some unique challenges.
Moderna generated revenues of just over $60 million in 2019 while Pfizer — currently leading in the race for an FDA-approved vaccine — earned almost $52 billion.
With scant infrastructure of its own to draw upon, the company is depending heavily on manufacturing and distribution deals with established players in the industry. Swiss-based global manufacturer Lonza is currently making the first commercial batches of the drug substance for Moderna’s COVID-19 vaccine in the U.S. and will manufacture the first European batches in one or two weeks, Lonza Chairman Albert Baehny said in an interview this week.
Baehny said that while the massive endeavor to meet global vaccine demand involves significant logistical challenges, the company is nearly done ironing them out. For example, it’s been difficult to find the experienced people needed to man the firm’s four vaccine manufacturing lines, especially given the company’s rapid work rate and restrictions imposed by the pandemic.
“The speed has been a challenge. [The] second challenge is to find the people,” he said. “For each manufacturing line, you need 60 to 70 educated persons. We installed four manufacturing lines, so we have to identify and train these people. Then … you need to have access to the equipment, install the equipment and then test your manufacturing facility.”
Those manufacturing challenges, however, have been “almost resolved” in less than a year, Baehny said.
Distribution, another key aspect of large-scale vaccination, poses its own problems. Moderna has never seen an FDA approval for any of its products and has never had to initiate rollout of a drug, let alone one with such imposing manufacturing and distribution requirements. Baehny predicted, however, that Moderna’s vaccine will not be that hard to ship and store.
Unlike the vaccine candidates from Pfizer and AztraZeneca, which must be held at ultra-cold temperatures, the Moderna vaccine, which is based on unproven messenger-RNA technology, can be held at -4 Fahrenheit (-20 Celsius) for six months and remain stable. “Then you can put it in the refrigerator [for 30 days],” he said. “Those are standard conditions in the pharmaceutical industry, so I don’t see many problems for the distribution, for the shipping, and for the storage of Moderna’s vaccine.”
Pfizer’s vaccine, which was found to be 95 percent effective, may prove more difficult to distribute and store, as it must be kept at the ultra-cold temperature of -94F (-70 Celsius). The company is currently exploring how to best distribute it through a pilot program in four states, and its partner, BioNTech, is working on a vaccine formula that would enable it to be shipped at room temperature (DID, Nov. 18).
Both Moderna and Pfizer/BioNTech are expected to submit Emergency Use Authorization applications to the FDA in the next few weeks with predictions that they could deploy their vaccines to frontline healthcare workers and the vulnerable elderly populations before year’s end.
The 10-year manufacturing agreement between Lonza and Moderna tasks the Swiss company with producing the drug substance for Moderna’s coronavirus vaccine, mRNA-1273, which was this week reported to be 94.5 percent effective and will soon go through its final phase 3 efficacy analysis (DID, Nov. 17).
Under the manufacturing pact, Lonza will produce the equivalent of 400 million doses of the vaccine annually, while Moderna will be responsible for making 100 million doses, according to Baehny, who said expanding beyond half a billion doses per year would require the setup of additional manufacturing lines.
Moderna expects to have approximately 20 million doses of its vaccine ready to go in the U.S. by the end of the year and still anticipates producing 500 million to 1 billion doses globally in 2021. — James Miessler