The Coalition for Epidemic Preparedness Innovations, a global organization funding vaccine development, is the latest to announce such a pact, paying 19.7 million euros, or $22.2 million, to Stevanato Group, an Italian manufacturer of pharmaceutical containers, for 100 million glass vials that can hold up to 2 billion vaccine doses.
The fast-moving hunt for a vaccine has led to worry that even if scientists hit their mark, logisitical hurdles and shortages of basic materials could hinder distribution. Oslo-based CEPI has poured $829 million in nine different experimental coronavirus inoculations. Now, it’s also seeking to invest in production of simple but critical supplies such as solutions, rubber stoppers, syringes and glass vials.
“We’re looking at the supply chain right from the start to the end," said Melanie Saville, CEPI’s director of vaccine research and development, in an interview. Saville said that the group conducted a survey of global manufacturing capacity that “really highlighted that these are all vulnerable areas."
The 100 million vials manufactured by the Italian company will be made from type 1 borosilicate glass -- a pharmaceutical-grade container that’s been considered the gold-standard for vaccines and other therapies for decades. According to the world’s three largest manufacturers of the product, 50 billion borosilicate glass containers are already produced each year.
Earlier this month, the U.S. Biomedical Advanced Research and Development Authority and the U.S. Department of Defense reached agreements to expand domestic production of vials with Corning Inc., which received $204 million, and SiO2 Medical Products, which got $143 million. Large drugmakers have also struck deals to secure their own vials.
Many public-health experts and pharmaceutical executives have been worried about a potential glass-vial supply squeeze.
Bill Gates has sounded the alarm in various interviews. Rick Bright, the former director of BARDA, said in a whistle-blower complaint that his warnings about shortages of glass vials fell flat at the US Department of Health and Human Services. And Sanofi Chief Executive Officer Paul Hudson, who is shepherding two top vaccine candidates with the support of the US government, said in an interview that “finding a billion glass vials with approved stoppers is not easy to do."
Top biopharmaceutical companies have committed to manufacture shots “at-risk," which means building out manufacturing capacity and securing raw materials before their candidates are cleared for use. Awi Federgruen, the chair of the decision, risk and operations division at the Columbia Business School, said the speedy approach will strain the glass vial market as companies stockpile the product for still-unproven shots.
There are more than 140 vaccines in development for use against the coronavirus. Of those, only 16 are in human trials, according to the World Health Organization. While behemoths like Johnson & Johnson and Pfizer Inc. have reached their own deals for vials, smaller companies could be left empty-handed, Federgruen said.
“I’m worried there will be a tremendous battle to find enough capacity, when we get to the point that there are effective vaccines, and we’ll get into a geopolitical battle over this," he said. “We don’t have the luxury to sit back and wait."
Stevanato Group produces 10 billion units of sterile and bulk glass containers, diagnostic and medical components, and other drug-delivery systems each year.
Chief Executive Officer Franco Stevanato said rapidly manufacturing another 100 million units will pose a challenge for the next 18 to 24 months, but won’t overly strain the company. The production process requires procuring sand, melting it down in large oven-like tanks, reforming glass into tubes, and then shaping it into vials or syringes, all before sterilization and additional packaging.
Since glass vials are custom-made for the acidity level of the solutions they hold and temperatures at which they are stored, among other specifications, Stevanato Group can’t begin manufacturing until the vaccine candidates are closer to the finish line. Once CEPI selects a shot or shots, the vial-production process will move quickly, he said, speaking from Venice.
“We’re not talking about months," Stevanato said, “We’re talking about weeks."
Stevanato and other glass makers don’t expect a vial shortage to impede global efforts to curb the pandemic. The two other largest glass manufacturers -- Schott AG and Gerresheimer AG -- released a joint statement on June 16 saying they will ensure there is “ample supply" of containers.
Schott Chairman Frank Heinricht said he’s working with “all the big guys" involved in Covid-19 vaccine development. Those drugmakers have approached Schott asking for 800 or 1 billion containers each, which Heinricht describes as an impossible task if you “multiple those numbers by five or six companies." But should two or three companies pull through, that’s doable, he said.
Schott is investing more than $1 billion to increase production of borosilicate glass, and purchase machinery so that it can produce 500 to 1 billion vials specifically for coronavirus pandemic response efforts, Heinricht said. The largest of its 12 factories can already produce 12 million vials per week.
“It’s a race of innovation," he said, “and we will not be a bottleneck."