A shortage of large, sterile plastic bags used to grow vaccine cells has hobbled Novavax’s work to scale up its COVID-19 shot production.
CEO Stan Erck told the Observer that the shortage of the 2,000-liter bags is a threat to the global supply of vaccines.
In late March, a European Union official told Reuters that Novavax had delayed signing a contract to supply COVID-19 vaccines to the EU because it was struggling to secure some raw materials.
“They are slowing down the process of finishing the contract,” the official said.
Gaithersburg, Maryland-based Novavax had tentatively agreed to supply 100 million doses to Europe by the end of 2021, with an option for another 100 million doses next year.
Meanwhile, Novavax has pushed its supply goal of 150 million vaccine doses per month from the end of the second quarter to the third quarter.
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Early last month, the CEO of manufacturing giant the Serum Institute of India, which produces the Novavax shot, said that the United States’ push to lock up raw materials for the Pfizer vaccine through the Defense Production Act could hinder other vaccine suppliers around the world.
During a virtual World Bank panel discussion, Adar Poonawalla specifically mentioned bags and filters as vital products that were lacking.
“The Novavax vaccine … needs these items from the U.S.,” Poonawalla said. “If we’re talking about building capacity all over the world, the sharing of these critical raw materials is going to become a limiting factor—nobody has been able to address this so far.”
The World Health Organization echoed the warning.
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The Novavax COVID-19 vaccine has yet to win approval in Europe or the U.S. But the company has kicked off manufacturing at a Fujifilm Diosynth plant in Billingham, England. A GlaxoSmithKline facility 30 miles away in Barnard Castle will soon be ready to take on the fill-finish process.
Novavax also has lined up U.S. manufacturers for its vaccine, including a deal struck last month with Jubilant HollisterStier to provide fill-finish from its plant in Spokane, Washington.
With the rapid development of its COVID-19 vaccine, Novavax has been a rags-to-riches story. It has secured the use of 20 manufacturing sites in nine countries on four continents.
But those manufacturing assets can’t be maximized if raw materials can’t be secured, Erck warned.
“There’s the media that the cells have to grow in,” Erck told the Observer. “You grow them in these 2,000-liter bags, which are in short supply. Then you pour it out and you have to filter it and the filters are in short supply. The little things count.”
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