On Friday, President Donald Trump announced a “massive scientific, industrial, and logistical endeavor” called “Operation Warp Speed,” to find, manufacture and distribute a proven vaccine against Covid-19, hopefully before the end of the year.
To achieve this “great national project,” as Trump called it, will take a collaboration of American businesses, scientists, the federal government and the military.
The announcement comes on the heels of the May 12 Senate testimony of White House advisor and immunologist Dr. Anthony Fauci. He testified that scientists hope to know whether there is at least one effective vaccine against Covid-19 by late fall or early winter but that it will take a year to 18 months to get a vaccine to market, even at “the top speed we’re going.”
However, Trump is not alone in his push to go “big and fast” on a vaccine that protects against SARS-CoV-2, the virus that causes Covid-19. In certain corners of the scientific community, there are whispers of speeding up further an already accelerated timeline.
But one thing is for sure: It will take unprecedented collaboration.
From fast tracks to biotech
There are many possible avenues to speed up a vaccine.
Historically it has taken decades to put out a safe, effective vaccine. The chickenpox vaccine took 28 years to develop, for example, as did the FluMist influenza vaccine, which can be sprayed in the nose. That’s because it typically takes five to 10 years of research and development, which includes animal testing, before a vaccine can move to human clinical trials. Then human trials, which happen in several phases, with different numbers of and populations of people, can take six to eight years or more.
That’s not to mention FDA approval, which, according to The New York Times, can take a year, and manufacturing, which can take anywhere from six months to three years, according to the global health-care giant Sanofi.
Already with Covid-19, many of these development, production and regulatory timelines have been shortened to get to the time frame of 18 months to two years.
And Operation Warp Speed will advance manufacturing capacity for chosen vaccine candidates “while they are still in development” rather than “after approval or authorization,” as is traditional, according to the U.S. Department of Health and Human Services.
There is also the use of new science.
Specifically, founders Nikolai Eroshenko and Hannu Rajaniemi name as tools allergen testing and proteonomics, or the study of proteins. A 2015 study called proteonomics “a powerful tool for studying pathogens for vaccine development and the host response to infection and immunization.”
Using these biotechnologies could speed up what is “by far the biggest bottleneck in the development timelines” by pinpointing potential safety issues before human trials with large numbers of people take place, according to Eroshenko and Rajaniemi. They posted their proposal for a $10 billion, six-month vaccine timeline to Medium in April.
“We were thinking in terms of having the manufacturing capacity ready for the final vaccine candidates, not necessarily having 7.6 billion doses all done,” Rajaniemi tells CNBC Make It of the six-month time frame. “Although you could certainly start making hundreds of millions of doses while the trials are still ongoing.”
A new ‘Manhattan Project’
But no one can do it alone.
On Friday, Trump called Operation Warp Speed “unlike anything our country has seen since The Manhattan Project,” a historic collaborative effort between government, companies and scientific academics during World War II, except in that case it was to develop a nuclear weapon.
Before that, Eroshenko and Rajaniemi used the same comparison in their accelerated timeline proposal: “Six Months To A Vaccine: A New Manhattan Project for COVID-19,” they wrote on Medium.
The Manhattan Project references highlight a major strategy nearly every expert, as well as Trump, talks about as crucial to accelerating a vaccine timeline: collaboration.
Collaboration among small biotech companies “with agile teams and cutting edge technologies,” big pharma companies “with manufacturing capability and clinical development experience,” academic labs, the federal government and philanthropists is crucial, Rajaniemi tells CNBC Make It.
The idea is to “aggressively develop several parallel solutions to every technical problem” in getting to a vaccine, including “design, delivery, manufacturing, distribution logistics, etc,” Eroshenko and Rajaniemi wrote on Medium.
“This can take place at an unprecedented speed (see Figure below) and removes the bottlenecks faced by vertically integrated companies.”
Figure courtesy of Helix Nano
The Scientists to Stop Covid-19, a self-described group of “passionate citizen-scientists,” agree the fastest approach to a Covid-19 vaccine requires cooperation, specifically a governmental council to coordinate efforts globally, standardization in the way data from clinical trials is reported, full transparency of who is doing what and coordinated plans to manufacture and administer the vaccine.
Trump’s Operation Warp Speed will leverage the military to speed up distribution. “This historic partnership will now bring together the full resources of the Department of Health and Human Services with the Department of Defense. And we know what that means. That means the full power and strength of military,” Trump said on Friday.
And already big players are working together.
Moderna, for example, one of the front-runners for developing a coronavirus vaccine, was awarded $483 million in April from the federal government’s Biomedical Advanced Research and Development Authority, or BARDA, to invest in its advanced clinical trials and its manufacturing process. Moderna announced Monday that the first phase of human trials for a messenger RNA vaccine candidate shows evidence of eliciting an immune response.
“We believe that we would be able to supply millions of doses per month in 2020 and with further investments, tens of millions per month in 2021, if the vaccine candidate is successful in the clinic,” Moderna CEO Stephane Bancel said in a written statement.
Johnson & Johnson, which is working on an adenovirus Covid-19 vaccine and aims to start human clinical studies by September, has collaborated with the federal government, too. At the end of March, Johnson & Johnson announced a “significant expansion” of its partnership with BARDA: Together they committed more than $1 billion “to co-fund vaccine research, development, and clinical testing.”
Johnson & Johnson is also partnered with Beth Israel Deaconess Medical Center and the vaccine immunology expertise there, specifically Dan Barouch, the director of its Center for Virology and Vaccine Research. ”It is critical to work with the best scientific minds,” Paul Stoffels, Johnson & Johnson’s chief scientific officer, said in a statement.
“The search for a vaccine is one that relies on partnerships,” Johnson & Johnson says on its website.
Researchers at the University of Oxford began clinical trials in humans of its vaccine candidate in April. The university has a partnership with biopharmaceutical company AstraZeneca to ensure the vaccine is made “available and accessible for low and medium income countries,” according to a statement.
“This collaboration between Oxford University and AstraZeneca is a vital step that could help rapidly advance the manufacture of a coronavirus vaccine,” Alok Sharma, a British politician who is serving as the secretary of state for business, energy and industrial strategy, said in the statement.
It is this level of integration in the effort to get a Covid-19 vaccine to market that’s new.
“Of course there has been collaboration in vaccine development before — just no Manhattan Project, where a central body leads it DARPA style and assembles the optimal technology stack together,” Rajaniemi tells CNBC Make It.
Indeed, “I have never seen more researchers focused on the treatment and prevention of viral infections all at once,” vaccine specialist Barbara Rath, co-founder and chair of The Vienna Vaccine Safety Initiative, tells CNBC Make It.
“For those of us who have worked in the field for a long time, this is encouraging,” she says.
Racing to the finish line has its limits
For what it’s worth, even with collaboration, there are plenty of experts who eschew timelines as fast as six to eight months.
An eight-month timeline for a vaccine “is incredibly optimistic,” Harvard Medical School professor and epidemiologist John Brownstein tells CNBC Make It.
That’s because it’s “tough to compress timelines where you need adequate testing of healthy individuals and to monitor them over time,” says Brownstein, chief innovation officer at Boston Children’s Hospital, who has advised the World Health Organization, Institute of Medicine, the U.S. Health and Human Services and Homeland Security departments, and the White House.
Bill Gates, whose Bill & Melinda Gates Foundation has pledged to spend billions on accelerating vaccine manufacturing, said in an April 30 blog post that a vaccine could be developed in as little as nine months. But “it’ll take months — or even years — to create 7 billion doses (or possibly 14 billion, if it’s a multi-dose vaccine), and we should start distributing them as soon as the first batch is ready to go,” Gates wrote.
And while “a Manhattan Project-style bundling resources to focus on a common goal may indeed help to save time” and the “exponential” acceleration in research could “save us months to years,” it could come at a price, according to Rath.
“I use the metaphor of building a house, because in science, new knowledge will build on knowledge gained before you, like one brick is laid upon another. While everyone is focused on the moment when the roof is decorated and the ribbon is cut, the effort going into creating a solid foundation is often underappreciated,” Rath tells CNBC Make It.
For example, “we are only at the beginning of understanding the full spectrum of symptoms,” she says.
“In other words, we need to understand exactly what it is that we want to prevent in order to construct the most effective vaccines. Basic research is indispensable, takes time and is a lot more difficult to communicate or to get funded. There are amazing scientists working tirelessly in research laboratories around the world who deserve our applause and support just as much as the front-line health-care workers.”