How Fauci’s Moonshot For Future Pandemics Could Build Out A Vaccine Assembly Line
Lucky is the last word that comes to mind when thinking about Covid-19, a worldwide pandemic that has killed millions, locked down entire nations and rattled world markets. But Dr. Barney Graham, a researcher responsible for key research that helped create the coronavirus vaccine, believes that luck played a big role in the creation of the therapeutic.
“If it was a bunyavirus or an arenavirus, we would have been lost for months or a year or two just trying to get the right thing made,” he said, referencing two of the many virus families that could still spark a global outbreak.
Graham’s research, recent global experience with SARS and MERS, as well as breakthrough mRNA technology, conspired to create a vaccine in record time. Seeking to get lucky twice isn’t a strategy.
That’s why Dr. Anthony Fauci, the immunologist leading the national effort against Covid and head of the National Institute of Allergy and Infectious Disease, has a different idea for combating the next pandemic. As reported in The New York Times last month, Fauci has proposed a five-year, multibillion-dollar plan to fund research for “prototype vaccines,” focused on the 20 virus families most likely to spark a pandemic.
Graham, who hatched the idea in a 2018 paper, suggests even more significant federal investment in mRNA research and biomanufacturing, on top of the increased budget proposed by the Biden administration, will prime the pump for lab construction.
The stakes, especially for lab and biomanufacturing space, could be massive. The $18B Operation Warp Speed program to rapidly develop and deploy a Covid-19 vaccine invested billions to ramp up manufacturing capacity at more than 25 sites across the country, per Paul Mango, deputy chief of staff for policy at the Department of Health and Human Service.
“This is a very exciting time,” said Derek Lowe, a drug discovery chemist and author of In the Pipeline, a blog that covers vaccines and biomanufacturing. “It’s like what happened to airplanes in World War II. Due to sheer necessity and pressure to succeed, the technology advanced rapidly. The whole field of mRNA is never going to look the same after this.”
Maryland-based companies alone received over $6B in funding in the past 20 months to expand manufacturing capacity, said Pete Briskman, executive managing director and co-lead for JLL's Mid-Atlantic Life Sciences Practice, Fujifilm Diosynth Biotechnologies, located in the Research Triangle, netted a $1.6B contract.
It’s all leading to a huge construction pipeline underway, especially in East Coast markets, per CBRE. Currently, 100K SF in Boston, 266K SF in Philadelphia, 450K SF in Washington, D.C., and Baltimore, and 574K SF in Raleigh-Durham are all under construction, which won’t meet the demand (biomanufacturing tenants are seeking 2M SF in Raleigh alone).
While there aren't any figures available for total mRNA manufacturing capacity in the U.S., the growth of some of the big players suggests it’s expanding considerably. Moderna announced in May it will expand its Norwood, Massachusetts, plant, more than doubling the existing facility from 300K to 650K SF and acquiring a 240K SF building on the same campus. The expansion is part of the company’s plans to spend roughly half a billion dollars on capital investments this year. An all-new mRNA plant for a federal vaccine effort would cost an estimated $700M and take three years to complete.
With proper funding, the program, which has already been discussed with White House officials, would likely start in 2022. NIAID confirmed to Bisnow that Fauci's proposal existed, but a spokesperson declined to provide updates about a potential timeline or funding requests attached to it. Fauci told PRI that it will “cost a considerable amount of money,” and that “they’ve already started the planning process.”
Other countries and even companies have spoken of similar pandemic resilience strategies. Moderna CEO Stéphane Bancel spoke about a “never again plan” within the company to do similar research on potential pathogens, which would enable much more rapid production and distribution of a vaccine.
“Imagine a universe where we could have started Phase 3 trials of our vaccine in March , instead of Phase 1 trials,” Bancel told Advisory Board in July. “We could have had an emergency use authorization by July, and if we'd had a factory cranking 50 million doses a month that whole time — which is not a crazy-sized factory — we could have had 300 million doses available in the fall.”
The science behind Fauci’s proposal is backed by the history of Covid-19 vaccine development. Previous research on SARS and MERS discovered the antigenic sequence of similar viruses, Lowe said. Scientists knew it entered humans via the ACE2 protein, and also knew the spike protein was the weak link in the virus and the ideal place to attack. What’s unknown is just how a well-funded effort would impact the already tight market for lab space nationwide.
Dr. Justin Richner, an immunologist and researcher at the University of Illinois-Chicago, runs a lab developing an mRNA vaccine for dengue fever. Since there’s already expertise in immunology and vaccine research across the country, he foresees NIAID and the NIH incentivizing basic research with a call for grant proposals.
“That’s the most expeditious way to do it, and has been a highly successful model for the NIAID in the past,” he said. “It’s all about finding the Achilles' heel of the pathogen that can induce a robust immune response. That’s not a nontrivial question — we’ve been working on HIV for years, with no good target.”
Richner believes much of the research for this effort would happen in pre-existing labs, simply bolstering the work of experts like himself (without the possibility of spinoffs or other commercialization from such research, it wouldn’t have the economic impact of research grants in other fields). A previous effort by a Baylor University scientist to develop a SARS vaccine, which could have been a prototype for Covid, lasted from 2012 through 2017 when federal funding ran out. It was never able to begin human trials.
Later in the process, as candidates move to human trials and need more high-security facilities, it’s possible NIAID facilities may be utilized, such as the national and regional biocontainment laboratories or NIAID laboratories in Bethesda, Maryland, the Rocky Mountain Laboratories in Hamilton, Montana, or the Intramural Research Facilities at Fort Detrick, Maryland.
The proposal’s potential impact on life sciences real estate and development is likely to come into play on the manufacturing end of the process. But the extent of the growth and investment in new factories and facilities is tough to gauge. The pharmaceutical world sees great promise in mRNA therapeutics, now that it has been proven to work for vaccines, but will likely find more profits in applications like oncology or producing a flu vaccine.
Fiona Barry, associate editor of PharmSource GlobalData, which covers biomanufacturing and contract manufacturing, believes the government would be better off supporting the industry’s growth and reserving production slots in advance. There’s a large, growing contract manufacturing sector that would make for good partners in case of emergencies, and the large upfront investments in mRNA manufacturing, especially the cost of specialized machinery, as well as the limited number of firms able to do such work, suggests going it alone may be cost-prohibitive.
Just retrofitting an existing plant to make vaccines would cost an estimated $127M for BioNTech-Pfizer or $270M for the Moderna vaccine, an analysis by Imperial College of London found.
“Investing in partnerships, and helping companies that are already growing, makes more sense than growing its own capacity,” Barry said.
Lowe said that, since capacity isn’t always going to be needed for the “goddamn coronavirus,” and mRNA technology is fairly plug-and-play, it would be easy to flip the switch on existing production lines and make new vaccines.
“My guess is you won’t build up enough manufacturing capacity to do massive human vaccination, but have enough to be ready to roll with the preclinical stuff,” Lowe said. “This is nontrivial manufacturing, and you’d want to shore up the system by getting a larger and larger cohort of people manufacturing these things and troubleshooting them. The number who could realistically do it can be counted on your two hands.”
The government decisions on who to partner with could also have a big impact on the wider industry, said JLL Executive Manager Pete Briskman, helping certain companies, or perhaps serving as a boon to an emerging region. A recent report about pandemic-era changes to biomanufacturing by BioPlan Associates argues that billions will be invested in new manufacturing capacity, especially in hubs outside the top life sciences markets of San Francisco, San Diego and Boston.
“If allocated to many companies in a single geography, it should have a major impact and catapult that region to a whole new competency level,” Briskman said. “This includes organizations hiring more employees and expanding academic infrastructure to support increased investment.”
Fauci has a long history of trying to catalyze and jump-start vaccine development and production. He’s run federal programs and invested federal money in efforts to produce anthrax vaccines in the wake of 9/11 (during a 2006 concert in Washington, D.C., Bono dedicated a song called Miracle Drug to Fauci) and helped foster the creation of an Ebola vaccine years before Operation Warp Speed and other federal support helped accelerate the creation of a Covid vaccine. If he can fund and follow through with this effort, he may fundamentally change our fortunes regarding pandemics.
“It’s like infrastructure. We could put off investing in it for a few years,” Lowe said. “Hopefully, we don’t do that in this case.”