Moderna Ditches 400,000 doses of vaccine but still set to meet target

Photographer: Adam Glanzman / Bloomberg

Moderna Inc. had. to remove 400,000 doses of its Covid-19 experimental image after a seed case damaged the product at the final stages of manufacturing, a U.S. official said Thursday.

Moncef Slaoui, chief scientific adviser of Operation Warp Speed, revealed the manufacturer of Moderna in an interview with Bloomberg News. The 400,000 doses, which have not yet been put into filters, were part of a wider 1.4 million batch of the vaccine, Slaoui said.

Moderna, however, is still on track to meet its production estimates of 20 million doses this month, and 85 to 100 million doses for the U.S. in the first quarter of 2021, according to Ray Jordan, a spokesman for the Cambridge-based company, Massachusetts. .

Jordan declined to comment on the issue of seeding, or removal of supply.

Moderna’s two-dose regimen uses messenger RNA technology similar to the one used in the Pfizer Inc.-BioNTech SE vaccine authorized for emergency use by the Food and Drug Administration last week. The Moderna scene was being reviewed by federal councilors on Thursday and could get their own emergency use permit from U.S. regulators within days.

The 400,000-dose loss, meanwhile, is largely a reduction in the bucket for Moderna’s primary goal of delivering 500 million to 1 billion doses in 2021. Slaoui, an immunologist and deputy drug industry official, that the filtering issue is just one of many examples of how companies need to monitor their production lines and resolve issues in real time.

Such challenges are expected when a complex manufacturing process is followed as required for the Moderna messenger RNA vaccine, according to Slaoui. This level of challenge will not affect overall yield or speed of production, he said.

“From my experience, it goes as smoothly as any other manufacturing process I’ve experienced in my 30-year career in the industry,” said Slaoui, who spent nearly three decades working at GlaxoSmithKline Plc, where he led the company’s vaccination unit, said of the manufacture of Moderna and Pfizer-BioNTech mRNA vaccines.

Drug dealers usually collect a new product before launching it to the market, Slaoui explained. But in this case, he said, “that would be immoral. ”

As a result, Covid-19 vaccine manufacturers are currently under “the microscope literally looking at the day-to-day production of a very complex manufacturing process. “In my opinion,” said Slaoui, “there is no problem.”

Glass vials

Moderna has been co-developing its Covid-19 candidate with the National Institute of Allergies and Infectious Diseases, a unit of the National Institutes of Health, and has turned to Operation Warp Speed, the U.S. vaccine development program, for financial support and procurement. in the research, development and manufacture of its vaccine.

The government has taken steps to ensure Moderna does not go downstream of mainstream streams from suppliers.

“Everyone in the Warp Speed ​​side of things is trying to dual store,” said Lawrence Ganti, president and chief business officer of SiO2 Material Science, which won a $ 143 million U.S. contract to filter such as making glass for a candidate Moderna vaccine, as well as pharmaceutical packaging and syringes for imaging and other Covid-19 therapeutic treatment.

With Moderna, “we have been told that we are ahead of the majority in the supply chain agenda, both good and bad. Sometimes we are told, we have nowhere to put your lips, keep them for a day or so, or another week, ”Ganti said in an interview.

Scaling up

Moderna has agreements with Lonza AG Group to increase dose production at sites in Portsmouth, New Hampshire and Visp, Switzerland, and with Catalent Inc., which fills vaccine filters and packs them for distribution at the Bloomington, Indiana site, Laboratorios Farmacéuticos Rovi site in Madrid, Spain for finishing work outside the US SiO2 applies its filters to Catalent.

“There are a lot of moving parts, and they run out,” Ganti said.

Instead of putting vials in single weekly loads, SiO2 delivers them in smaller trucks three or four times a week to make up for their lack of storage.

“These little things don’t affect the whole situation, they’re small things, and just weird,” he said.

For Moderna, SiO2 makes up to 40 million filters, each of which can hold 8 to 10 doses.

“Theoretically they will have enough for two hundred million doses,” he said. By the end of this week, it will have shipped 12 million filters for Moderna, all of which will be used to fulfill U.S. supply orders.

“The first run of the filters is entirely for the U.S., which is the priority,” Ganti said. “If we could only make ten filters, what those ten have to go to the US, it cannot be shared between Europe because of our partnership with Operation Warp Speed. The U.S. market has a benefit priority for our bottle. “

– Supported by Robert Langreth