- The U.S. government is handing hundreds of millions of dollars to help two manufacturers of drug vials dramatically increase production, part of an expansive and ambitious effort to prepare for the success of a coronavirus vaccine.
- Drug developers like Moderna, Pfizer and AstraZeneca are quickly advancing experimental vaccines through clinical trials, readying manufacturing in parallel should testing prove a candidate safe and effective. One unexpected sticking point, however, might the vials needed to hold the vaccines.
- In separate contracts announced this week, the Biomedical Advanced Research and Development Authority, or BARDA, and the Department of Defense agreed to provide $204 million to New York's Corning, and $143 million to the Auburn, Alabama-based SiO2 Materials Science.
Collectively, the leading coronavirus vaccine developers are projecting to make more than 6 billion doses of their experimental candidates through next year, a staggering total that would stretch drug factories across the world to the limit.
Most vaccines won't succeed, or at least not on the highly ambitious timelines their developers have now sketched out. But their projections give some sense of the enormous manufacturing challenge that stands in the way of global inoculation.
With the help of government funds, drugmakers are refitting existing factories and securing production capacity with contractors to ensure they can produce their vaccines at scale. But to get any successful vaccine to hundreds of millions of people, companies will also need vast quantities of vials.
"There's a global glass shortage, which presents significant challenges just in vialing enough vaccine to deliver to all of the people who will need it," said Richard Hatchett, CEO of the Coalition for Epidemic Preparedness Innovations, at a virtual meeting hosted by the industry trade group BIO. Since January, CEPI has funded several coronavirus drugmakers.
Pharmaceutical company CEOs are also concerned. Some, including the heads of Pfizer, Johnson & Johnson and AstraZeneca, are considering whether they could fit five or even 10 vaccine doses into a single vial to conserve supplies.
The BARDA grants to Corning and SiO2 should help increase the number of vials available, at least in the U.S. Funding is part of 'Operation Warp Speed,' a Trump administration initiative that aims to ready a vaccine for use by Americans at the end of this year, or early next.
Corning, a large glass manufacturer that already works with pharma, will use the money to scale up tubing and vial manufacturing at its plants in New York, North Carolina and New Jersey. Vaccine developers designated by BARDA will get priority access to this additional supply, the company said, a potentially significant benefit to being chosen for Operation Warp Speed.
No drugmakers were specified, but Corning recently signed an agreement to provide glass vials to Pfizer, which has partnered with the German BioNTech on a coronavirus vaccine
SiO2 will use BARDA's cash to scale up capacity to make 10 million vials per month by November, Lawrence Ganti, the company's chief business officer, told BioPharma Dive in an interview. SiO2, which has spent a decade perfecting a glass coating that can be applied to plastic vials, can currently make about 5 million to 8 million vials a year, Ganti said.
Three coronavirus drug developers are currently working with SiO2, although Ganti did not disclose which ones. The company, which is private, has previously received investment from Novartis, and works with a number of other drugmakers on medicines in development for diseases other than COVID-19.
SiO2 is also planning to hire 200 engineers and scientists as a result of the BARDA grant, additions that would roughly double its current workforce.