President Donald Trump hailed his administration’s effort to develop a COVID-19 vaccine as a once-in-a-generation push that would “achieve a victory over the virus by unleashing America’s scientific genius” in record time.
Trump said during a visit to Fujifilm Diosynth Biotechnologies in Morrisville, North Carolina, on July 27 that the joint public-private program to develop a vaccine, dubbed “Operation Warp Speed,” has shaved years off the time it typically takes to develop one, “while maintaining the FDA gold standard for safety.”
“This is the fastest a vaccine for a novel pathogen has ever gone,” Trump said, referring to the CCP virus, the novel coronavirus that emerged from China last year and spread into a global pandemic that has paralyzed nations and thrown economies into lockdown.
Operation Warp Speed is a novel approach to the development, testing, manufacturing, and delivery of a vaccine, under a paradigm that involves overlapping phases of vaccine development that shortens the time-to-market for a viable candidate.
“Instead of the usual sequence of vaccine development, testing, and trials, followed by production, our strategy is to conduct these phases simultaneously,” Trump said.
Dubbed the “pandemic paradigm” of vaccine production, the process was described in detail in a scientific paper published in the New England Journal of Medicine by researchers at the Coalition for Epidemic Preparedness Innovation (CEPI), an international nongovernmental organization.
Because of the cost and high failure rates, vaccine developers typically follow a linear sequence, pausing many times to analyze data and check their manufacturing processes. While that saves money by preventing misinvestment in non-viable vaccines, it drags out the development process.
“Everything goes at one time. We’re not waiting and waiting and waiting,” Trump said. “We’re mass producing all of the most promising vaccine candidates in advance so that on day one that it’s approved, it’ll be available to the American people immediately.”
“And we’ll probably have a lot for a lot of other people throughout the world,” the president added.
The Moderna vaccine has entered phase three of clinical trials, the final stage before approval, Trump noted, adding that a second vaccine would likely enter phase three “in a matter of days.”
Operation Warp Speed has provided funding to multiple promising vaccine candidates, including via a $1.6 billion investment in Novavax, a $483 million contract with Moderna, a $1.2 billion contract with AstraZeneca, a $465 million contract with Janssen, and a $1.95 billion agreement with Pfizer.
“Tremendous progress is being made with all of those great companies,” Trump said, adding that the contract with Pfizer includes a guarantee to deliver 100 million doses almost immediately after the vaccine is approved, with an option to buy another 500 million doses.
“Not only is Operation Warp Speed accelerating the development of a vaccine, we’re also directing a colossal industrial mobilization to ensure its rapid delivery. Nothing has happened like this since the end of World War Two,” Trump said.
Besides vaccines, the program also involves COVID-19 therapeutics, with Trump saying that over 140 clinical trials were now underway in this regard.
The president said the medical advances around vaccine and therapeutic development have provided insight into how the virus operates, contributing to a drop in COVID-19 related mortality.
“In the middle of April, more than 22 percent of all deaths in the United States were attributable to the China virus. As the last week, that number has dropped down—as of last week, it’s dropped down to under 7 percent,” Trump said.
A key objective of Operation Warp Speed is to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021.
While the number of new daily recorded COVID-19 cases has accelerated in the United States since the end of June, Worldometers data shows, the count of new daily deaths has dropped since its April peak of around 2,500 per day to less than 1,000 per day, on average, in recent weeks.
The number of new daily COVID-19 deaths on July 27, according to figures compiled by Worldometers, was highest in Texas (97), California (92), Florida (78), Ohio (33), and Louisiana (23).