Moderna Ditches 400,000 Vaccine Doses But Still Set to Meet Goal

(Bloomberg) -- Moderna Inc. had to discard 400,000 doses of its experimental Covid-19 shot after a filtration issue compromised the product during the final stages of manufacturing, a U.S. official said Thursday.

Moncef Slaoui, Operation Warp Speed’s chief scientific adviser, disclosed Moderna’s manufacturing hiccup in an interview with Bloomberg News. The 400,000 doses, which weren’t yet placed in vials, were part of a broader 1.4 million batch of its vaccine, Slaoui said.

Moderna, however, remains 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, Massachusetts-based company.

Jordan declined to comment on the filtration issue, or the discarding of supply.

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

The 400,000-dose loss, meanwhile, is somewhat of a drop in the bucket for Moderna’s overarching objective of producing 500 million to 1 billion doses in 2021. Slaoui, an immunologist and former drug industry executive, said the filtration issue is just one of many examples of how companies must monitor their production lines and problem-solve in real time.

Such challenges are to be expected when pursuing a complex manufacturing process like that needed for Moderna’s messenger RNA vaccine, according to Slaoui. This level of challenge will not effect overall output or the pace of production, he said.

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

Drugmakers typically stockpile new product before launching it into the marketplace, Slaoui explained. But in this case, he said, “that would be unethical.”

As result, Covid-19 vaccine makers are currently under “the microscope looking at literally the daily output of a very complex manufacturing process. “In my judgment,” Slaoui added, “there is no problem.”

Glass Vials

Moderna has been co-developing its Covid-19 candidate with the National Institute of Allergy 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 and logistical support in researching, developing and manufacturing its vaccine.

The government has taken measures to ensure that Moderna doesn’t face downstream headwinds from suppliers.

“Everybody in the Warp Speed side of things is trying to dual source,” said Lawrence Ganti, the president and chief business officer of SiO2 Material Science, which was awarded a $143 million contract from the U.S. to produce glass-like vials for Moderna’s vaccine candidate, as well as pharmaceutical packaging and syringes for other Covid-19 shots and therapeutics.

With Moderna, “we’ve been told we’re ahead of most in the supply chain schedule, which is good and bad. Sometimes we’re being told, we don’t have any place to put your vial, hold them for a day or so, or another week,” said Ganti in an interview.

Scaling Up

Moderna has agreements with Lonza Group AG to scale up production of doses at sites in Portsmouth, New Hampshire and Visp, Switzerland, and with Catalent Inc., which is filling vaccine vials and packaging them for distribution in its Bloomington, Indiana, site, an Laboratorios Farmacéuticos Rovi’s Madrid, Spain-based site for fill-finish work outside the U.S. SiO2 ships its vials to Catalent.

“There are a lot of moving pieces, and they are running flat out,” Ganti said.

Rather than send vials in one weekly shipment, SiO2 delivers them in smaller trucks three to four times a week to accommodate their lacking storage.

“These little things don’t impact the overall situation, they’re little things, and just annoying,” he said.

For Moderna, SiO2 is producing as much as 40 million vials, each of which can hold 8 to 10 doses.

“Theoretically they’ll have enough for a couple hundred million doses,” he said. Through the end of this week, it will have produced 12 million vials for Moderna, all of which will be used to fulfill U.S. supply orders.

”The first run of the vials is absolutely for the U.S., that’s the priority,” Ganti said. “If we could only produce ten vials, than that ten has to go to the U.S., it can’t be split between Europe because of our partnership with Operation Warp Speed. The U.S. market has a privileged priority to our bottle.”

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