The world will likely need billions of doses of any vaccine that’s proven safe and effective against the new coronavirus. But there’s not enough glass vials to hold all those doses, creating another supply headache for drugmakers to solve as they work feverishly to complete clinical testing in record time.”The challenge is not so much to make the vaccine itself, it’s to fill vials,” said Pascal Soriot, CEO of AstraZeneca, on a Thursday conference call hosted by an industry trade group. “There’s not enough vials in the world.”AstraZeneca, along with its large drugmaker peers Pfizer, Johnson & Johnson and Sanofi, is working to quickly produce hundreds of millions of doses of its vaccine candidate even before studies show it’s sufficiently safe and effective to be used globally.
In order to deliver a vaccine within 12 to 18 months, drugmakers are attempting to accomplish in succession several goals that, if achieved on their own, would be without precedent.
Clinical testing for vaccines typically proceeds in carefully calibrated stages — stretching many years, if not past a decade. Manufacturing at scale usually occurs only after early- and mid-stage studies show a candidate to be reasonably likely to succeed. And even then, drugmakers often aim only to win approval for and supply treatment for specific groups of people, before making their vaccine available more widely.
Responding to the coronavirus pandemic, and the devastating toll it’s taken on countries across the globe, has required drugmakers to conduct all of those activities at once. Massive financial investments by companies, governments and nonprofit groups, along with new science and some newfound flexibility, has helped keep research and development on a fast track.
But the breakneck pace is exposing the hurdles that will quickly emerge to supplying the world with any vaccine proven out in testing. Glass vials, in particular, are emerging as a sticking point.
In an effort to conserve limited supplies, AstraZeneca, J&J and Pfizer are all exploring whether they could safely fit five or 10 doses of vaccine into one vial.
“Typically, we are producing vaccines in single-dose vials,” said Albert Bourla, Pfizer’s CEO, on the Thursday conference call. “We’re also exploring with the governments right now if it would be more convenient if there are 5- or 10-dose vials.”
“If we can find out this could be a presentation that is acceptable and practical given the pandemic, I think we can resolve a significant part of the bottleneck of manufacturing,” he added.
Paul Stoffels, chief scientific officer at J&J, was a bit more blunt.
“Getting to five or 10 vaccines per vial is probably going to be essential to be able to cope with the volume,” he said Thursday. “The capacity is not there to do it in the billions.”
Rick Bright, the former director of the U.S. Biomedical Advanced Research and Development Agency, claimed in a recent whistleblower complaint that it could take two years to make enough vials for U.S. vaccine needs.
Bright alleged he had warned the Trump administration to prepare for a vial shortage, but “to no avail.”
Vial manufacturers, such as Corning, can scale up their production but, like others, they were caught off guard by the pandemic’s spread.
On Thursday, Corning said it had signed a new, multi-year agreement with Pfizer to supply its “Valor Glass” packaging. The agreement is initially planned to provide vials for “several key sterile injectable medicines,” a Pfizer spokesperson said in an email, but the company is evaluating Valor Glass for its potential coronavirus vaccine as well.