Leaders of the effort to develop a COVID-19 vaccine said Tuesday more than 60,000 Americans have volunteered to participate in clinical trials at six different pharma companies with the goal to begin distributing a vaccine by January.
Operation Warp Speed, created by the Trump administration just five months ago, has been working on an unprecedented dual track of developing and preparing a nationwide distribution system even before an effective vaccine is approved, according to U.S. Army Gen. Gustave Perna, chief operating officer of Operation Warp Speed. The goal is to have millions and tens of millions of doses of one or more vaccines available much faster than normal,” Perna said during a webinar sponsored by The Heritage Foundation.
The joint project between the Department of Defense and the Department of Health and Human Services aims to develop and manufacture as many as 300 million doses of one or more vaccines by early 2021. Perna, the commander of Army Materiel Command, or chief supply officer, was named in May by President Trump to lead the vaccine project just weeks before being scheduled to retire after 39 years in the military.
Because of the seriousness of the pandemic, the research and development process, which normally takes as long as five-to-10 years for a major vaccine, like those for polio, measles or smallpox, has been consolidated into a matter of months, according to Dr. Matthew Hepburn, head of vaccine development for Operation Warp Speed. “We can meet the ambitious challenge of Operation Warp Speed,” said Hepburn.
Gen. Perna said the federal government has set aside $10 billion for the development and distribution of a vaccine. Six companies: including Johnson & Johnson, AstraZeneca, Moderna, Novavax, Sanofi and Pfizer, have begun broad clinical trials seeking as many as 30,000 volunteers each. The trials will entail half of the volunteers being exposed to the experimental vaccines and the other half exposed to placebos, or fake vaccines, in order to test for efficacy, according to Perna. Since most vaccines are tested with around 5,000 volunteers, this will give clinicians a broader and better measurement on the potential of the vaccines, he said.
The plan is for millions of doses of the approved vaccines to be available by December, then tens of millions of doses to be available in the January-March period, Perna explained. Under the project, manufacturing facilities have been built from the ground up. “This is really a remarkable task on its own,” he added.
The government has contracted with McKesson Corp., the nation’s second-largest pharmaceutical manufacturer, to distribute the tens of millions of doses of the approved vaccine or vaccines, and with FedEx and UPS to transport the necessary doses. Major pharmacy chains including Walmart, CVS, Walgreens and Kroger have also been signed to aid in the distribution process.
Perna said the project has used Defense Procurement Act authorizations to get private industry to prioritize contracts and material and make available supply and distribution resources. He said once one or more vaccines are approved they will need to be distributed throughout all of the U.S., in major cities and tiny hamlets, as well as to overseas Americans. “It’s just a Herculean task all on its own,” he asserted.
Once vaccines are distributed they will need to be tracked to determine who has received a dose (or two if necessary) and the efficacy of the treatment. Five of the six vaccines being tested require a single dose; the Johnson & Johnson product would require two. According to Hepburn, tracking also will be necessary to determine what side effects or other impacts there may be. The tracking may also help in determining what other pathogens may be susceptible to these vaccines or what other viruses may be treated using one or more of these products.
The process being planned for distribution of the COVID vaccines differ from those used to distribute other vaccines, such as the influenza vaccine, which Perna called a pull method and is based on demand. In contrast, a COVID vaccine would be distributed using a push method. “We’re going to be pushing it down to all parts of America,” he said. “Eventually we will transition to a pull.”
Any vaccine must obtain final approval from government regulators, including the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention, and the Department of Health and Human Services before it is distributed to the public, Hepburn said. He emphasized that safety and not politics or another consideration will be paramount. Then the states will determine the final distribution process. “It’s really a collective team approach to that process, he stated.
There may be a scenario where more than one vaccine is approved. In that case, “we’ll let science lead the process,” said Hepburn.