The Biden administration is launching a $5 billion-plus program to accelerate development of new coronavirus vaccines and treatments, seeking to better protect against a still-mutating virus, as well as other coronaviruses that might threaten us in the future.
“Project Next Gen” - the long-anticipated follow-up to “Operation Warp Speed,” the Trump-era program that sped coronavirus vaccines to patients in 2020 - would take a similar approach to partnering with private-sector companies to expedite development of vaccines and therapies. Scientists, public heath experts and politicians have called for the initiative, warning that existing therapies have steadily lost their effectiveness and that new ones are needed.
“It’s been very clear to us that the market on this is moving very slowly,” Ashish Jha, the White House coronavirus coordinator, said Monday. “There’s a lot that government can do, the administration can do, to speed up those tools . . . for the American people.”
Jha and others said the new effort will focus on three goals: creating long-lasting monoclonal antibodies, after an evolving virus rendered many current treatments ineffective; accelerating development of vaccines that produce mucosal immunity, which is thought to reduce transmission and infection risks; and speeding efforts to develop pan-coronavirus vaccines to guard against new SARS-CoV-2 variants, as well as other coronaviruses.
Officials note that several coronavirus-driven outbreaks in the past two decades, including severe acute respiratory syndrome coronavirus in 2002 and Middle East respiratory syndrome in 2012, have spurred worries about the potential for future health crises related to the viruses. That said, a universal coronavirus vaccine could take years to develop; researchers have sought unsuccessfully for decades to create such a vaccine against influenza.
Some of the lab work is underway, and the government has begun efforts to find potential private-sector partners, said Dawn O’Connell, assistant secretary for preparedness and response at the Department of Health and Human Services.
“We’ve begun surveying the landscape out there - assessing what vaccine candidates are available, [and] moving through what exciting technologies are there,” O’Connell said. Her team last week informed companies working on monoclonal antibodies that the government may make new investments in the technology.
Jha declined to set timetables for when the products might come to market, saying that would depend on drugmakers’ production plans, reviews by the Food and Drug Administration and other factors. “The timelines are really going to be predicated on how quickly the scientific advancements continue, and how quickly we can study and measure the efficacy and safety of these products,” he said.
The planned launch comes after Biden health officials had funding requests for the program repeatedly rebuffed by Congress, with Republicans insisting the administration had funds left over from prior coronavirus aid packages. A pot of money was finally created after the White House directed HHS to free up $5 billion for the initiative. The agency shifted funds intended for coronavirus testing and other priorities, potentially teeing up new questions from Republicans about why those funds were available.
The White House also held several events to promote the need for new therapies and engage scientists around those goals.
“We need vaccines that are more durable. Vaccines that offer broader and longer-lasting protection. Vaccines that can stand up to multiple variants. Vaccines that can handle whatever Mother Nature throws at us,” Jha said at a July 2022 White House coronavirus vaccine summit.
The Biden administration’s vaccine accelerator was originally dubbed “Project COVID Shield,” and some GOP lawmakers had suggested launching an “Operation Warp Speed 2.0″ to build on the Trump administration’s effort and signal a bipartisan approach. But White House officials wanted some distance from the Trump effort as well as from COVID-focused branding, when much of the country had moved on from the pandemic, said two people who spoke on the condition of anonymity to discuss internal conversations.
Jha said “Project Next Gen” made sense as branding for a program focused on next-generation vaccines and treatments. “It’s a different time. We have a different set of goals. The name we have much more accurately captures what it is that we are trying to do,” he said.
Jha also said that investing in next-generation coronavirus vaccines could have beneficial effects across the health system. “Our ability to develop . . . vaccines that generate mucosal immunity will have very large benefits for other respiratory pathogens we deal with all the time, like flu and RSV,” he said.
Experts have said that government commitments are critical to accelerating the pace of next-generation therapies.
“We need to move quickly to start testing these nasal vaccines in humans, and that requires significant U.S. government input - both resources and help with manufacturing and delivery as well as acceptance across society,” Yale University immunologist Akiko Iwasaki said at last year’s White House vaccine summit.
Eric Topol, director of the Scripps Research Translational Institute, said he had talked to Jha repeatedly about the importance of moving forward on nasal vaccines and also a pan-coronavirus vaccine.
“It doesn’t take much to get the nasal vaccine across the goal line - that should be the first priority,” Topol said.
More than 1.1 million Americans have died of COVID-19 since the pandemic began, including more than 250,000 in 2022, according to the Centers for Disease Control and Prevention. While the number of serious cases and deaths have receded, at least 35,000 Americans have died this year, and some projections suggest that the coronavirus could surge again this fall and winter.
Current and former Biden administration officials, including Anthony Fauci, had spent months pressing Congress for billions of dollars that could be used to develop next-generation vaccines and treatments - arguments that largely fell flat, with GOP leaders asking for a thorough accounting of the billions of dollars already allocated to the broader COVID response.
“This was designed to pressure Republicans to open a checkbook, sign the check and let the administration fill in the balance,” Richard Burr, who was the top Republican on the Senate’s health panel, said at a June 2022 hearing with Biden health officials.
In recent months, Biden officials have argued to GOP lawmakers that both peer and rival countries, such as Japan and China, are moving ahead with similar projects.
Key parts of the new initiative are not yet finalized. The White House is still considering candidates to lead the program, officials said. The vetting process has been complicated by Democrats’ desire to avoid questions of conflicts of interest that dogged Operation Warp Speed, after Trump officials selected Moncef Slaoui, a pharmaceutical industry executive with significant stock holdings, to lead that program. That decision had prompted criticism from Democrats although health officials praised Slaoui’s knowledge of the industry and credited his successful bets on vaccine candidates from Pfizer-BioNTech and Moderna.
Project Next Gen also faces key differences from its predecessor, including its smaller size and more open-ended mission. The Trump-era project, focused on an urgent need with a defined virus, drew on funds that officials viewed as a blank check and was budgeted at $18 billion in 2020. While the new initiative is more modest, administration officials said they might secure additional money, even as they focus on blunting variants and viruses that have yet to emerge.
Even some of the Republicans who blocked the White House’s coronavirus funding requests last year said they wanted a “Warp Speed 2.0″ to rush updated vaccines and treatments that would better fight the virus.
“Operation Warp Speed was the most successful public health program since small pox. It saved millions of lives, and it should be resurrected as soon as possible,” Burr and then-Sen. James M. Inhofe (R-Okla.) wrote to Biden in August 2022.
O’Connell said the Biden administration had drawn lessons from Operation Warp Speed, such as how to expedite vaccine development, that would be applied to Project Next Gen.
“We’ve learned a lot in these three years,” she said.