Moderna sends COVID-19 booster shot for NIH testing as it hikes production targets past 2B doses

In the span of about a year, Moderna has gone from being a clinical-stage biotech with no marketed products to a key partner in the global COVID-19 vaccination effort. Now, it's doubling down on its manufacturing push, with more than 2 billion doses in its sights.

Moderna on Wednesday said it's now on track to produce 700 million vaccine doses this year, and it's still aiming for 1 billion at the high end. Last year, the company had said 500 million would be its minimum output this year, and it ratcheted up that minimum to 600 million in January.

And for 2022, the biotech is planning for 1.4 billion doses—or perhaps even 2 billion, depending on the dose required for booster shots targeting new variants. The company has shipped a booster candidate to the National Institutes of Health for testing, according to Wednesday's statement; it's targeted specifically at the South Africa variant now worrying public health experts.

To support the scale-up, Moderna on Wednesday said it's planning new investments at manufacturing sites, whether in its own network or sites operated by partners.

For next year, Moderna’s 1.4 billion target is based on the assumption that potential vaccine boosters will require the 100-μg dose. If boosters end up using a lower dose, such as 50 μg, the company could potentially churn out more than 2 billion doses in 2022, CEO Stephane Bancel said in a statement.

So far in its global rollout, Moderna has shipped 60 million doses worldwide. Most of those, 55 million, have gone to the U.S. Meanwhile, the biotech says its ex-U.S. supply chain is “in the process of ramping up.” The company plans to deliver 100 million doses to the U.S. before the end of next month and another 200 million by the end of July.

Part of the company's work to ramp up production includes identifying bottlenecks, and Moderna offered one example of progress on that front. The biotech and its partners found that fill-and-finish services were slowing down the overall manufacturing timelines, so Moderna is exploring the potential of 15-dose vials to relieve those services and reduce the need for “consumable materials that are in high demand.”

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Even as Moderna scales up its original shot, mRNA-1273, the company is laying plans to tackle variants. The biotech plans to test its original shot as a half-dose booster and variant-specific and multivariant boosters at 50 µg and lower in people who’ve already had the standard vaccine regimen, today's announcement said.

In addition, the company is planning to study those variant-specific and multivariant vaccine candidates as primary vaccines for people who don’t yet have antibodies.

Moderna is one of the leading players in the COVID-19 vaccine push, but it isn’t alone in its aggressive efforts to scale up capacity. Pfizer and BioNTech are pushing to produce 2 billion doses in 2021, while Johnson & Johnson has pledged hundreds of millions of doses to the U.S. and other governments.  

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AstraZeneca has tapped a global network of manufacturing partners and is aiming to produce 200 million doses per month. Novavax, for its part, laid out a production goal of 150 million doses per month with the help of partners, its CEO said in January.

During a congressional hearing earlier this week, execs for Pfizer, Moderna and J&J said the companies could provide a combined 140 million new doses to the U.S. by the end of March. An AstraZeneca exec said the company could provide 50 million doses by the end of April, but that drugmaker hasn’t yet submitted its program to the FDA. Novavax is awaiting phase 3 trial results from a U.S. study, expected early next quarter.