How much could Operation Warp Speed change pharma, medtech distribution?

A top U.S. Department of Health and Human Services official used an appearance today at a virtual medtech conference to repeat the U.S. government’s astounding goal for its Operation Warp Speed program: start delivering 300 million doses of a safe, effective COVID-19 vaccine by January 2021.

The project could revolutionize not only how pharmaceuticals are distributed, but also medical devices and ancillary supplies, HHS Assistant Secretary Dr. Robert Kadlec claimed during The Virtual Medtech Conference hosted by AdvaMed.

The Centers for Disease Control and Prevention with U.S. Defense Department support is collaborating with the private sector — as well as state and local authorities — to meet Operation Warp speed goals, Kadlec said. Top private sector partners include McKesson, which has a COVID-19 vaccine distribution agreement with HHS and DoD, as well as providers of ancillary supplies such as Becton Dickinson (NYSE:BDX).

“When a dose of vaccine is approved by the FDA, no corner is cut, no shortcut is taken. We can basically deploy that vaccine and begin administering it in 24 hours. That is an extraordinary target and goal that Warp Speed has,” Kadlec said.

As HHS explained while releasing distribution strategy documents in September, McKesson will work under CDC’s guidance, with logistical support from DoD, to ship COVID-19 vaccines to administration sites.

The vaccine distribution will go through three phases, according to the strategy documents. The distribution will start in a focused manner, with the goal of maximizing vaccine acceptance and public health protection while minimizing waste and inefficiency. As more vaccine doses become available, distribution will expand to the wider population. Americans will receive the government-purchased vaccines at no cost.

Top experts inside the government — including Dr. Anthony Fauci of the National Institute of Allergy and Infectious Diseases and Dr. Robert Redfield of the CDC — have said the U.S. could be months into 2021 before a COVID-19 vaccine is widely available.

For now, the federal government is making investments in the necessary manufacturing capacity at its own risk — even as a handful of vaccine candidates remain in Phase 3 clinical trials. FDA told COVID-19 vaccine developers yesterday that it needs two months’ worth of safety data before it will consider emergency approvals — defying calls from President Donald Trump to hurry up the vaccine approval process.