Get Warped: What the U.S. Government COVID Vaccine Development Program Is Doing

Five months ago, the U.S. government set up Operation Warp Speed (OWS), an ambitious program meant to accelerate diagnostics, facilitate supplies, and produce vaccines and therapeutics to fight COVID-19. Here’s what’s going on with the program now.

Development of a vaccine, which normally takes years, could be accomplished within only about a year. This is four times as fast as any other vaccine has been developed. The OWS program has spent $10 billion so far to help with vaccine development, production and distribution. And the vaccine makers aren’t waiting around; even though their vaccine candidates are still in trials, they are already making doses, in anticipation of distributing them immediately once the vaccine is approved. before they even know if the vaccines work.

They have stockpiled hundreds of thousands of doses. The U.S. now has contracts with 6 vaccine makers and may add a couple more, according to Moncef Slaoui, the scientific head of OWS. The U.S. has prioritized getting doses for its citizens before providing doses for poorer nations.

While the U.S. has committed to 800 million initial doses and has options for another 1.6 billion, they are not alone. Worldwide, governments that can afford it have committed to over 4 billion vaccine doses. Richard Hatchett, CEO of CEPI — the Coalition for Epidemic Preparedness Innovations noted recently that what the U.S. has done to get vaccines into development quickly will benefit the whole world.

Said Hatchett:

“I don’t think you can characterize the behavior of the country as being all one thing or another. They have invested… many billions of dollars in terms of funding the basic work and the clinical trials and the development of vaccines that will serve the needs of the world. They have invested more than all the rest of the world in aggregate.”

Drug wholesaler McKesson will be used to distribute the coronavirus vaccines. McKesson already distributes the annual flu vaccines. Some worry cargo theft could be an issue with distribution. Another problem will be vaccine storage; some of the vaccine candidates need to be stored at very low temperatures. For example, the Pfizer vaccine must be kept at -94⁰F. Other vaccines may require other temperatures, complicating distribution if more than one vaccine is approved.

Meanwhile, the government is working on increasing supplies of syringes and glass vials needed to administer the vaccines. The OWS has given $138 million to ApiJect to develop a product that prefills syringes with vaccine doses. Apiject is expected to create 100 million prefillable syringes this year and 500 million in 2021. The Apiject technology had never been tried except as a prototype before the pandemic, which has raised some questions as to whether the device is safe and can be produced in a large enough quantity to serve the needs of the U.S.

The government has also given money to Corning ($200 million) and SiO2 Materials Science ($143 million) for glass vials and glass-coated plastic containers, respectively.

Another important piece of fighting the coronavirus is therapeutics. OWS has invested $450 million in Regeneron for manufacturing of its monoclonal antibody treatment once it is out of clinical trials. OWS is also funding studies of a similar drug from Eli Lilly.

The often-discussed COVID-19 treatment remdesivir, a drug developed by Gilead Sciences, was already in U.S.-funded studies before OWS involvement. Remdesivir is considered a frontrunner for treatment of the virus, as it shortens recovery time in patients. In U.K.-funded studies, the steroid dexamethasone has been shown to benefit COVID-19 patients.

The Nation Institutes of Health Rapid Acceleration of Diagnostics (RADx) program is doing more than the OWS with regard to test development. By the end of 2020, RADx hopes to increase test capacity by 6 million per day over what is being done now.

Disclaimer: This article does not provide medical advice. Do not take action based solely on this article and always consult with an appropriate healthcare professional. This article is purely for informational purposes.

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