President Donald Trump has enlisted a former GlaxoSmithKline PLC vaccines executive and the U.S. military to speed the developing, manufacturing and distributing of a coronavirus vaccine.
Operation Warp Speed, a taxpayer-funded, public-private collaborative initiative, will be a "massive scientific, industrial and logistical endeavor unlike anything our country has seen since the Manhattan Project," Trump said, citing the World War II-era effort to develop the first nuclear weapons.
Trump put Moncef Slaoui, a venture capitalist who spent 30 years at GSK — eight of those years leading the company's vaccines development — in charge of the Warp Speed effort. Other former GSK leaders playing prominent roles in other COVID-19 initiatives include ex-CEO Andrew Witty, a special envoy for the World Health Organization, and Patrick Vallance, who oversaw GSK's research and development and is now the U.K. government's chief scientific adviser.
U.S. Army Gen. Gustave Perna was named COO and will handle logistics for Warp Speed — an effort that U.S. officials have been talking about publicly for weeks but that Trump had not officially disclosed until May 15.
While Warp Speed will also involve drugs and diagnostics, it will focus largely on pushing out a COVID-19 vaccine as soon as possible.
Trump said he wants a COVID-19 vaccine ready by January 2021 or sooner — a timeline many scientists and experts have called unrealistic and would involve cutting corners, putting safety at risk.
National Institute of Allergy and Infectious Diseases Director Anthony Fauci has repeatedly said a COVID-19 vaccine could be ready within a year to 18 months, but only if there are no setbacks and everything runs smoothly.
Fauci's agency and its partner Moderna Inc. started work on a coronavirus vaccine in January.
During a May 4 online forum, Peter Marks, director of the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research, discussed developing a safe and effective vaccine. He said that if manufacturers and regulators could get rid of the "dead space" in the development process and take risks not normally pursued, a COVID-19 vaccine could be developed within nine months — putting the timeline at this fall.
But Fauci told a Senate committee May 12 that the idea of having a vaccine by fall — even at top speed — "would be a bit of bridge too far."
He also emphasized that there are no guarantees any of the vaccines in development will be safe and effective, though he said he was cautiously optimistic that at least one successful candidate would eventually emerge.
Slaoui acknowledged that the task ahead to meet the January 2021 timeline will be "extremely challenging," though he said he was "confident" Warp Speed's government and private-sector partners would "do the utmost to deliver" on the goal.
Perna also noted that the Warp Speed team was facing a "herculean task," but said the combined strengths of the federal health and military agencies and company collaborators involved would "ensure our success."
More than 100 COVID-19 vaccines are in development, with about a half dozen in phase 1 human testing.
Trump said 14 of those products have been identified for the Warp Speed project, adding that only about half of those will be carried forward.
In a May 15 statement, HHS said three to five of those vaccine candidates progress to large, randomized safety and efficacy trials.
Once a vaccine candidate shows sufficient safety and efficacy, manufacturing those products will be scaled up to be quickly distributed once they are proven ready for public use, Trump said from the White House Rose Garden.
Billionaire philanthropist Bill Gates had earlier proposed a similar approach of scaling up manufacturing before vaccines have completed clinical trials — or at-risk manufacturing. Gates has already contributed $100 million to the research and development of candidates and said he would make billions of dollars more available for the effort.
Trump said U.S. taxpayers will be bearing the costs of the at-risk manufacturing under Warp Speed.
Congress had already allotted about $10 billion for drugs, vaccines and diagnostics in its four coronavirus relief packages.
Trump did not outline any additional funding for the Warp Speed project, and the White House and HHS declined to comment.
Trump said Warp Speed would involve partners from around the world, though he did not disclose the nations involved.
Whatever country develops a vaccine first will share it with the U.S., which would do the same for other countries, he said.
But Trump opted not to participate in the WHO's global effort, called Access to COVID-19 Tools Accelerator, and the White House has cut off U.S. funding for the group.
Consumer advocacy group Public Citizen called on Trump to make any plan his administration has for global equitable distribution for any successful COVID-19 vaccine transparent.
The group also said that any contracts the government has signed with companies in the Warp Speed project should be made publicly available, in addition to the research data, "so that independent experts can analyze the safety and efficacy profiles of candidate vaccines."