The Trump administration is working up a Manhattan Project-style joint initiative, bringing biotech, pharma and federal agencies together to speed up the work—and let the U.S. government take on the financial risks.
Dubbed “Operation Warp Speed,” the project’s goal is delivering 100 million doses of a viable COVID-19 vaccine by the end of the year, according to the report. It would be a radical acceleration of the typical vaccine development timeline, which is typically described in years, not months.
To help move things along, the administration wants to help biopharma companies coordinate their separate efforts with assistance from federal agencies and the U.S. military, according to the report. U.S. taxpayers would fund the losses from failed projects, Bloomberg reports.
For instance, officials are exploring a master trial protocol that would allow researchers to study numerous vaccines at the same time rather than separately through independent studies by each company.
To speed up distribution, the team is planning to scale up manufacturing capabilities as the vaccines enter large human trials. Bill Gates has pitched such an approach, and he’s acknowledged the strategy will result in billions of lost capital spending as many projects fail.
Over the past two months, drugmakers, academics and others have started dozens of COVID-19 vaccine projects. Johnson & Johnson has inked manufacturing deals in recent days to prep for its rollout, while GlaxoSmithKline, Sanofi, Pfizer and Merck also have R&D projects underway.
The “Operation Warp Speed” program arises from the administration’s desire to smash the 12- to 18-month timeline often quoted for developing a COVID-19 vaccine, which itself is optimistic.
Analysts and others have predicted it could be several years before the world sees a vaccine, and, historically, some vaccines have taken decades to develop.
Still, some vaccine programs are moving ahead with unprecedented speed. Researchers with Oxford University’s Jenner Institute plan to start a 6,000-participant trial next month, The New York Times reports. The team is also working with drug manufacturers in Europe and Asia to quickly produce up to 1 billion doses upon a potential approval.
Also this week, Pfizer said it might be ready for an emergency rollout by the end of 2020, The Wall Street Journal reports.
Source: Fierce Pharma