Moderna is angling to produce upward of 1 billion doses of its COVID-19 vaccine in 2021, but that's nothing compared to what it has in store for next year.
Thanks to planned investments across its own U.S. facilities and those of its manufacturing partners in Europe, Moderna now expects to supply between 800 million to 1 billion doses of its COVID-19 vaccine this year—and that’s just the tip of the iceberg. By 2022, the company could supply up to 3 billion doses worldwide.
Moderna will use its own cash for the upgrades, which it aims to start paying out this year. The undisclosed sum should fuel a production ramp-up late into 2021 and early 2022, the company said Thursday morning.
As virus variants emerge, Moderna is increasingly hearing from a mix of governments, public health officials and scientists that mRNA vaccines are the best way forward, president Stephen Hoge, M.D., said in an interview.
“We believe that this virus has just started to fight back, and it is evolving, and we are seeing variants of concern emerge that are re-infecting people," he said. As those variants spread, vaccine makers who are able "need to update their vaccines really quickly," he said. Moderna, for its part, started work on a variant booster and a multi-valent booster in January, he noted.
Stateside, the cash will tee up a 50% increase in drug substance production at Moderna's own facilities. In Switzerland, CDMO Lonza is expected to double drug substance manufacturing from its Visp plant, while Rovi will more than double formulation, fill-finish and drug substance production at its facility in Spain.
The supply boost will come in addition to Moderna’s recently expanded fill-finish deal with contract manufacturer Catalent and the production tie-up with Sanofi it unveiled this week. Moderna says it’s in advanced talks for other manufacturing pacts, too.
“I do think in certain parts of our supply chain we are going to be making large, maybe multi-fold increases," Hoge said, noting that Moderna likely wouldn't need to chart the same sort of three-fold capacity boosts it outlined Thursday.
He offered fill-finish, the final step of the production process where vaccine doses are loaded into vials, as a potential example. The company is working with 10 and 14-dose vials now, “but in the future you can imagine that you might want to go down to the 5-dose vial or even single-dose vials because they might work better in different resource settings," Hoge said. Going from a 10-dose vial to a single dose vial would prompt the need for 10-times the filling capacity, he explained.
One potential clue about a Moderna partner-to-be? White House officials earlier this month set up a meeting between Moderna and specialty drugmaker Nexus Pharmaceuticals to discuss a potential manufacturing deal.
Meanwhile, Moderna clarified that its 3 billion dose target may shift based on the mix of vaccines it’s ultimately tasked to supply. The biotech has won FDA and EMA authorization for a 100-microgram dose of its mRNA vaccine, which is given as two injections, but it’s also working on lower-dose formulas for variant-specific boosters and pediatric vaccines.
If those shots pass muster in the clinic, Moderna could potentially be on the hook for a mélange of single-dose boosters, its standard two-course vaccination series and a two-dose regimen for kids, which may come at a lower dose.
The company says it will be able to offer a firmer supply estimate for 2022 as it hones its booster-shot business strategy and more data from its variant studies roll in.
Manufacturing delays and concerns about rare but serious blood clots have cast a shadow over AstraZeneca and Johnson & Johnson’s adenovirus-based shots in Europe. Meanwhile, the EU recently launched legal action against AZ for failing to deliver its promised supply of COVID-19 vaccines, while Italian daily La Stampa reported in mid-April that the EU wouldn’t re-up on its J&J and AZ contracts once they expire at the end of the year.
As a result, Pfizer and Moderna will likely take an upsized role in supplying their mRNA shots to the bloc. To make sure it can meet its deliveries, Moderna says it will also use a piece of the investment to increase its "safety stock" of raw materials and finished product.
“You wish you had months of all of the critical consumables and raw materials—everything from plastic bags to lipids and everything in between," Hoge said, but the reality is that Moderna, like all pandemic vaccine makers, has been working "hand-to-mouth."
The challenge is that “anytime we get our hands on something, we’re trying to convert it into a vaccine dose, and we’re working around the clock to do that," he said. The goal, to hear Hoge tell it, is to work more efficiently so it's not at risk of shortage.
“We’re aiming at 800 million to 1 billion doses this year, but to get the 3 billion doses we’ve got to run real efficient, and that means you’ve got to have a little bit of safety stock everywhere.”
Meanwhile, Moderna's vaccine could be looking at warmer days ahead. The company says it has ongoing development data on its authorized vaccine formula that could support three month's refrigerated storage for the shot in "alternative formats." Moderna's vaccine is authorized now for up to one month of storage at fridge temps of 2 degrees to 8 degrees Celsius (35.6 degrees to 46.4 degrees Fahrenheit) and can be kept for up to seven months at freezer temps of negative 20 degrees C (negative 4 degrees F).
That storage update could prove a "game changer" for distribution in low- and middle-income countries that may not have the freezers for cold chain distribution, Hoge said. Helping deliver those shots to low- and middle-income countries is an "explicit" focus of the expansion, he added.
This isn't the first time Moderna dialed up its production target this year. In February, the company said it was on track to supply a minimum of 700 million doses this year, up from a previous baseline of 500 million doses. At the time, it said it would shoot for a high-end target of 1.4 billion doses, or perhaps even 2 billion, in 2022.
As of Wednesday, April 28, Moderna had delivered around 128 million vaccine doses to the U.S, according to the Centers for Disease Control and Prevention. The company could reel in some $14 billion in vaccine revenues this year, Bernstein analyst Ronny Gal predicted earlier this month.
Editor's note: This story has been updated with comments from Stephen Hoge, M.D., president of Moderna.