- Drugmakers selected for "Operation Warp Speed," the Trump administration's ambitious plan to develop a coronavirus vaccine in record time, will enjoy priority access to manufacturing capacity secured by the U.S. government, as well as to needed supplies like glass vials.
- Announced by President Donald Trump on May 15, Operation Warp Speed is a Manhattan Project-like attempt to test, manufacture and distribute a safe and effective vaccine to Americans by early next year. On Tuesday, administration officials shared more specifics, revealing they aim to have 300 million doses ready by January 2021.
- Whether any vaccine is proven by then to prevent coronavirus infection is far from guaranteed, however. A handful of experimental vaccines, such as Moderna's and AstraZeneca's, have advanced quickly into mid-stage testing, with large Phase 3 trials planned for this summer. U.S officials said they aim to support about seven candidates through Operation Warp Speed.
The U.S. government has already committed sizable funds to advance vaccine candidates from Moderna, Johnson & Johnson and AstraZeneca, as well as a smaller sum for a vaccine being developed by Sanofi and GlaxoSmithKline.
That money, granted through the Biomedical Advanced Research and Development Authority, will support large-scale clinical studies, as well as help fund the manufacture of hundreds of millions of doses in parallel with testing.
No companies have been announced as among the roughly seven finalists envisioned by Operation Warp Speed, although The New York Times and Bloomberg reported in early June that the field had been narrowed to include five to seven drugmakers.
Meanwhile, the U.S. is also investing in contract manufacturers, producers of drug vials and syringe makers — capacity and supplies that would be preferentially available for developers taking part in Operation Warp Speed.
New York-based Corning, for example, recently received $204 million from the U.S. government to ramp up its production of a more durable type of glass vial. Access will be prioritized for "designated BARDA vaccine and drug development partners," Corning said.
Contract manufacturer Emergent Biosolutions, which was awarded up to $628 million by BARDA, said it will support the "leading COVID-19 vaccine candidates selected by the U.S. government." The Maryland-based company is already working with AstraZeneca and J&J.
"Vaccine, therapeutic and diagnostic developers involved with OWS will be the primary beneficiaries of the manufacturing and distribution capacity," a senior administration official said in a statement to BioPharma Dive. "However, OWS will not reject the idea of assisting other developers with promising solutions."
Developing a safe and effective vaccine in the 12 to 18 month timeline being pushed by U.S. government officials would be a tremendous scientific feat in and of itself. But producing any such vaccine at a global scale, and distributing it to hundreds of millions of people, is also a monumental challenge — making the additional support the U.S. government can bring potentially critical.
Drug vials, for instance, could be a major bottleneck for vaccine developers.
"The challenge is not so much to make the vaccine itself, it's to fill vials," said Pascal Soriot, CEO of AstraZeneca, on a May conference call hosted by an industry trade group. "There's not enough vials in the world."
Through investments in Corning and a lesser known company called SiO2, the U.S. government hopes to boost vial production by nearly 300 million vials per year.
Stevanato, Gerresheimer and Schott — three of the world's largest vial manufacturers — said Tuesday they're committed to supplying enough vials for any successful coronavirus vaccine.
The U.S. government's support comes with conditions, though. Companies that are backed by Operation Warp Speed will provide the U.S. government an allocation of the vaccines they develop, and a senior administration official said Tuesday a successful vaccine would be available for free to any American who can't afford to pay.
Americans would be first in line for vaccines procured by the U.S. government but, "to the extent there is a surplus, [the U.S. has] an interest to ensuring folks around the world are vaccinated," the official said.