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Lonza to manufacture Moderna COVID-19 vaccine, lifting annual capacity to 1B doses

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Moderna has secured mass manufacturing capacity for its COVID-19 candidate vaccine through a deal with Lonza and is already scoping out a Phase III trial design, Moderna CEO Stéphane Bancel told BioCentury.

The deal comes in the same week that AstraZeneca plc (LSE:AZN; NYSE:AZN) and Serum Institute of India announced plans to mass produce a COVID-19 vaccine that Oxford University’s Jenner Institute is developing (see “AstraZeneca to Make COVID-19 Vaccine” and “India Emerging as Major COVID-19 Vaccine Manufacturer”).

The deals underscore the importance and urgency of securing capacity and starting to make candidate COVID-19 vaccines at-risk before safety and efficacy has been demonstrated.

Moderna Inc. (NASDAQ:MRNA) teamed up with Lonza Group Ltd. (SIX:LONN) in part because the contract manufacturer can ramp-up production rapidly, Bancel said.

Lonza’s manufacturing will start to supplement Moderna’s starting in July, Bancel said. “The goal this year is to produce several million doses per month; by the beginning of next year several tens of millions of doses per month; and later hundreds of millions of doses per month.”

Moderna’s estimates are based on the expectation that individuals will receive two 25 μg injections. The number of doses available would change if the dosage is different.

“If everything goes perfectly -- and that’s a big ‘if’ -- we could start the pivotal study in late summer or early fall.”

Stéphane Bancel, Moderna

In a best-case scenario, mRNA-1273 could be ready for emergency use in the fall and Moderna could start submitting a rolling BLA in December or January, Bancel said.

Ten-year deal

Moderna and contract manufacturer Lonza entered into a 10-year agreement for Lonza to make mRNA-1273 in the U.S. and Switzerland. Lonza could expand the agreement to manufacture the vaccine at its Singapore facility, Bancel told BioCentury.

Technology transfer will begin in June, and Lonza will start manufacturing material in July that could be used in trials or distributed on an emergency basis, according to Bancel.

Some of the manufacturing expenses are being covered under a $483 million contract Moderna received this month from the Biomedical Advance Research and Development Authority (BARDA).

Moderna expects to have the ability to achieve its limit of about 100 million 50 μg doses per year, or over 8 million doses per month, by year-end, Bancel said. Lonza will over time increase capacity by tenfold, he added.

Moderna expects to supply the U.S. market from vaccine manufactured domestically at its own plant and Lonza’s facility, to supply Europe from Lonza’s Swiss facility, and to export to the rest of the world from these plants and possibly from Lonza’s Singapore facility.

“Everybody is hoping to secure local supply,” Bancel said. “We’ve heard that loud and clear from governments.”

Even with Lonza, Moderna will not come close to meeting global demand. “I hope several vaccines make it to the finish line because no single vaccine manufacturer can supply the planet,” Bancel told BioCentury.

Moderna plans to supply mRNA-1273 in 10-dose vials. The company has not finalized contracts for securing vials and filling them but it is on track to do so, Bancel said. “We have line-of-sight on how we get this product into vials,” including by tapping into a global network that BARDA has mapped out.

Summer study

Moderna has submitted an IND for a Phase II trial of mRNA-1273 and plans to start the trial “as soon as FDA allows” and has started designing a Phase III trial, Bancel said.

The Phase III trial will be “over-powered” to increase the chances of getting it completed quickly, he told BioCentury. Working with NIH’s National Institute of Allergy and Infectious Diseases, Moderna will enroll volunteers across the country and will have the ability to increase enrollment in places where the virus is most active.

“If everything goes perfectly -- and that’s a big ‘if’ -- we could start the pivotal study in late summer or early fall and by the end of the year or early next year start filing a rolling BLA,” Bancel said.

Hundreds of thousands of doses of mRNA-1273 could be available in the fall, well before Moderna is ready to start submitting its BLA.

Any decision to request Emergency Use Authorization would be made by the U.S. government, Bancel said. “We want to be helpful. If it makes sense for the country that in the fall we make [a submission for] emergency use access for healthcare workers, we’ll do that.”

FDA will also have the final say about dosing.

Moderna hasn’t shared data on the potency of its COVID-19 vaccine; however, based on data from vaccines created using the same mRNA platform for other viruses the company expects that two doses spaced three weeks apart will be required to produce a powerful, long-lasting immune response, Bancel said. The company has observed protection after one dose, but this usually requires a larger dose and the protection isn’t as durable as a two-dose regimen, he said.

Other vaccines are likely to also present a choice between larger doses that provide quicker protection and two-dose regimens that use less antigen and provide longer protection, Bancel said.

“This is not a product we are trying to maximize profits on.”

Stéphane Bancel, Moderna

The trade-offs between administering a larger mass of antigen to achieve more rapid protection, the possibility that this protection will not last as long as a two-dose regimen, and the need to stretch limited supplies will pose difficult challenges for regulators and governments.

Bancel said he wouldn’t be surprised if a 250 μg dose provided immediate protection. This could lead to a scenario in which healthcare workers received the high dose to get quick protection and then received a second dose in a year.

At the same time, the elderly might receive two 25 μg doses spaced three weeks apart, with instructions to remain at home in the interval between doses.

Regardless of the dose, governments will also be faced with difficult allocation decisions, especially if they decide to distribute COVID-19 vaccine on an emergency basis before there are large stockpiles.

Bancel said it is possible that decisions will have to be made about who is vaccinated from the first 100,000 vials. He is very clear that the decision should and will not be made by Moderna or any other manufacturer. “No company should be making those decisions.”

While pricing decisions will be up to Moderna, Bancel said that if its vaccine is successful, the company will not seek to exploit its position. “This is not a product we are trying to maximize profits on.”

Bancel added that Moderna “has no intention to be in a place where because of a lack of supply we increase the price. That would be completely wrong.”

Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus.

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