- President Donald Trump on Friday officially unveiled 'Operation Warp Speed,' a highly ambitious government-led effort to accelerate the manufacturing and logistics preparations to quickly distribute any coronavirus vaccine that's proven effective in clinical trials.
- Moncef Slaoui, a former pharmaceutical executive and strong advocate for vaccines, will lead the project as its chief scientist, while current head of the U.S. Army Material Command, General Gustave Perna, will serve as chief operating officer, Trump confirmed Friday in remarks at the White House.
- Operation Warp Speed is currently focusing on 14 vaccine candidates that experts in the U.S. government judged to be the most promising from an initial list of over 100. The initiative's goal, Trump said, is to finish developing, and then produce and distribute, an effective vaccine as soon as possible, hopefully "before the end of the year."
Pitching Operation Warp Speed as a modern-day Manhattan Project, Trump is betting that, together, U.S. scientists, the military and private drugmakers can accomplish something never before achieved: a safe and effective vaccine available in just one year.
"We'd love to see if we could do it before the end of the year," the president said Friday at the Rose Garden, flanked by the heads of the health and defense departments, as well as Anthony Fauci, the U.S.'s top infectious diseases expert, and National Institutes of Health director Francis Collins.
A formal announcement from the Department of Health and Human Services set January 2021 as the goal for making "substantial quantities of a safe and effective vaccine available for Americans."
That would on pace with, or even faster, than the best-case scenario of 12 to 18 months which Fauci has repeatedly set out as an objective. Slaoui, the new face of Operation Warp Speed, was bullish on the president's hope for a vaccine by year-end.
"I have very recently seen early data from a clinical trial with a coronavirus vaccine," Slaoui said Friday, "and these data made me even more confident that we will be able to deliver a few hundred million doses by the end of the year." He did not specify which vaccine he was discussing.
Across the globe, drugmakers have designed and built vaccine prototypes for the new coronavirus with unprecedented speed. Moderna, a Cambridge, Massachusetts-based biotech that was first to launch human studies of a coronavirus vaccine candidate in the U.S., needed just two months to go from studying the virus' genetic sequence to dosing the first patient in a Phase 1 study.
By contrast, 20 months passed between identification of the SARS virus and first human testing. The fastest timeline for developing a vaccine is considered to be four years, for a mumps vaccine approved by the Food and Drug Administration in 1967. Most vaccines require many years, sometimes more than a decade, for trials to show they are safe and effective.
More than a half dozen vaccine candidates for SARS-CoV-2, which has sickened more than 4 million people worldwide, are now in clinical study. Moderna recently said its planned mid-stage trial was cleared by regulators to begin, and the company hopes to start Phase 3 testing by the summer.
Even if testing shows one vaccine to be promising enough to distribute on an emergency basis, regulators and scientists will likely know much less than usual about how well it works and whether it's fully safe for broad use across different population groups.
Manufacturing any vaccine will be an enormous, and costly, undertaking — something Operation Warp Speed is meant to specifically address by supporting efforts to start producing doses before testing is completed.
The U.S. government is already funding manufacturing build-outs by private drugmakers through grants given by the Biomedical Advanced Research and Development Authority. Operation Warp Speed will add to those efforts and help with producing and procuring the many items that go into a ready-to-use vaccine, like glass vials and syringes.
Even with the U.S. backing, readying manufacturing for year-end distribution will be extremely challenging — a "Herculean" task, Parna said.
Trump hinted the U.S. military would also play a role in the distribution of any vaccine successfully developed. "The U.S. government will deploy every plane, truck, and soldier needed to help distribute it to Americans," he said Friday.
Notably, companies that receive Operation Warp Speed support will have to commit to provide a donated allocation of their therapy to the U.S., HHS said in a statement.
Naming Moncef Slaoui to lead coronavirus response should lend credibility to a White House response that has been criticized for being too slow and focused more on economic impacts than public health.
Born in Morocco, Slaoui trained as an immunologist and microbiologist before joining a GlaxoSmithKline predecessor company as a bench scientist in 1988. He went on to head GlaxoSmithKline's vaccines business and research & development operations, and was a strong advocate for vaccines both as a public health intervention and as business opportunity.
Since leaving GSK in 2017, he has been a partner at venture capital firm Medicxi and has served on the boards of numerous companies, including Moderna, from which he will step down. Slaoui is also on the board of contract manufacturer Lonza, which is working with Moderna to produce its coronavirus vaccine.
It's not completely clear how Operation Warp Speed will work with existing government-led efforts to hasten vaccine development that are already ongoing.
In mid-April, the National Institutes of Health, along with the Food and Drug Administration, Centers for Disease Control and Prevention and other agencies, launched a partnership with 16 large pharmaceutical and biotech companies to prioritize COVID-19 drug candidates that seem most promising and streamline testing. The collaboration, dubbed ACTIV, will look at therapies as well as vaccines.
An HHS statement said Operation Warp Speed would coordinate ACTIV as well as ongoing work by BARDA and NIH.
And while Operation Warp Speed is U.S. led, other countries and groups are attempting to achieve similar aims. Lack of coordination is raising some concern, as are suggestions that nations might prioritize their own citizens for vaccination at the expense of other countries.
This week, for example, comments by Sanofi CEO Paul Hudson that the U.S. would receive the first doses of a vaccine being developed by the French drugmaker and GlaxoSmithKline sparked outrage in France and a summons from President Emmanuel Macron. BARDA has helped to fund Sanofi's vaccine research.
Board members of Sanofi have since walked back Hudson's remarks, which were made to Bloomberg.