How Will Moderna Meet The Demand For Its COVID-19 Vaccine?

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A worker passes through the security gate at the Moderna campus in Norwood, Mass., one of the sites where the biotechnology company is manufacturing its COVID-19 vaccine.

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Vice President Mike Pence speaks during a roundtable discussion at Catalent Biologics in Bloomington, Ind., on Tuesday.

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Moderna declined to comment, and suggested NPR speak with officials with the FDA and Operation Warp Speed, the more than $12 billion federal effort to make a vaccine widely available in record time. Operation Warp Speed has committed spending $4.1 billion on researching and developing the Moderna vaccine as well as buying 100 million doses to be delivered by the end of March and another 100 million to be delivered by the end of June.

Operation Warp Speed didn’t respond to requests for comment, and the FDA said it typically doesn’t comment on «compliance matters.

Making the key ingredients

Catalent is filling vials and getting them ready to send around the country, but other facilities are responsible for making the mRNA, the key substance at the heart of the vaccine, that Catalent puts in those vials.

Another well-known contract manufacturing company, Lonza, told investors in October that it is working with Moderna to make its coronavirus vaccine drug substance. Lonza is using two sites: one in Portsmouth, N.H., and another in Visp, Switzerland, and was aiming to complete the first batches by late October and early November, respectively.

Following an FDA inspection in February 2018, Lonza’s plant in Portsmouth did not receive a document detailing observations called a Form 483, implying inspectors mostly liked what they saw.

Lonza spokesperson Sanna Fowler says it was also inspected in October 2020, and has an «exemplary track record with the FDA and international regulatory bodies that conduct similar inspections. «The FDA have used the Portsmouth site as a training site for their inspectors, given its high standards, she wrote in an email to NPR. «Should the FDA decide an inspection of the Moderna facility is required, we are of course ready to receive them.

The other Lonza facility’s inspection wasn’t as spotless. In October 2019, FDA inspectors found problems with microbial control during certain plant processes. They also found inadequacies in the way the plant measured impurities like toxins released by bacteria. The facility has received several 483s in recent years as well as two import refusals, meaning the FDA twice detained drug product shipments for being out of compliance.

To do work on the Moderna vaccine, Lonza is setting up operations in «a new premises in Visp, Switzerland, rather than using its existing facility there, Fowler says. She points out that although the FDA has found problems at its existing facility, they didn’t result in a warning letter from the agency. Instead the inspectors’ findings were «successfully resolved. She says the import refusals were the results of problems further up the supply chain, rather than because of problems at the Lonza plant.

Furthermore, the Moderna vaccine substance the new Swiss that facility makes won’t be bound for the United States, according to Fowler. Instead, it will go to the European Union and Canada, for example.

Using a new facility

Moderna has said that it’s using a relatively new facility in Norwood, Mass., to make the vaccine.

«The vast majority of the U.S. production will be done in Massachusetts, Moderna co-founder Noubar Afeyan told NPR member station WGBH News in a Dec. 1 story.

Although the facility was built in 2018, it wasn’t registered with the FDA until this week and has never been inspected, records show. Typically, new facilities need to be inspected before the agency will allow their products to be released.

«While the design of the facility is based on current standards for biotechnology facilities, it has not been reviewed or pre-approved by any regulatory agency, nor has the facility been inspected by any regulatory agency such as the FDA, the company wrote in a June 2020 regulatory filing.

«We have only recently begun producing drug substance and drug product at the MTC [Moderna Technology Center] for our preclinical and clinical use, the filing continues. «We could incur delays in implementing the full operational state of the facility, causing delays to clinical supply or extended use of third-party service providers, resulting in unplanned expenses. In constructing the MTC facility, we have incurred substantial expenditures, and expect to incur significant additional expenditures in validating and operating the facility in the future.

The FDA doesn’t speak publicly about specific compliance matters except with the firms involved. However, agency spokesperson Alison Hunt said that the FDA regularly interacts with manufacturers to help resolve regulatory compliance issues when they crop up, and it has a number of tools to accomplish this.

When the FDA is weighing whether to grant emergency use authorization of a COVID-19 vaccine, it takes manufacturing into account, she wrote in an email to NPR.

«FDA expects manufacturers to submit sufficient data to ensure the quality and consistency of the vaccine product, Hunt wrote. «FDA uses available tools and information, including records reviews, site visits, on-site investigations and previous compliance history to assess compliance with current good manufacturing practice (cGMP) requirements.

You can contact NPR pharmaceuticals correspondent Sydney Lupkin at .