Threads of hope and caution stitched together a wide-ranging appraisal of COVID-19 vaccines at June 9's BIO Digital plenary, "A Way Forward." The good news, delivered by one of the world's most sober participants in the pandemic response, mercifully came first.
Expressing near certainty that multiple vaccines and therapeutics will see regulatory approval, Anthony Fauci, director of the NIH's National Institute of Allergy and Infectious Diseases, said he's "heartened by the fact that the industry has really stepped to the plate, very much differently than what we saw with SARS."
Gary Nabel, chief scientific officer for vaccines giant Sanofi SA and former director of the NIH Vaccine Research Center, concurred, noting that it's good to see varying mechanistic approaches across the pipeline, with some taking a protein-based approach and others using a gene-based tack, while yet others are focused on the use of inactivated whole virus. Using a "shots-on-goal" analogy, he said that "it's important, when you're trying to score that you not only take a lot of shots but that you vary the place on the hockey rink where you shoot from."
If everything goes right, said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, during the panel, "I truly believe there's probably room for multiple vaccines here," which would be especially helpful, he added, since it's likely there may be populations that benefit from one vaccine more than another.
With all that development work in play, global regulators have been active, he said, starting as early as January to align with each other in supporting both preclinical and early clinical work to battle SARS-CoV-2. More recently, their discussions have turned to determining what success will look like. Some of the topics of discussion, Marks said, are, "What will we need for demonstration of safety and efficacy? What will need to be done to make sustainability of manufacture for these vaccines?"
To some degree, that sustainability will come from coordination of existing resources, something that Coalition for Epidemic Preparedness Innovation CEO Richard Hatchett told BIO attendees is already underway. But with well over 200 vaccine candidates in development across the world, Hatchett also expressed caution: "I do think there is potential for a scramble, for pressure on raw materials," he said, pointing to issues such as the global glass vial shortage which, depending on how fill and finish work is done, could add additional constraints to vaccines already likely to be in relatively short supply. "We have to think end to end, really from the very beginning and make smart choices," he said.
Geopolitical tensions have already arisen as nations have contemplated what vaccine access might look like, such as when Sanofi suggested in May that the U.S. government would get first access to its product because it was first to fund the research. Marks said he thinks sentiments putting domestic access ahead of global cooperation likely won't be that big of a problem. "This is a global problem that we all have to address globally," he said. However, he allowed that "to the extent that we have our own capacities, we're gonna take care of what we have at home. In a sense, it's an oxygen mask on an airplane analogy," he said. "You're going to put on your own first, and then help others as quickly as possible."
John Markels, Merck & Co. Inc.'s president of global vaccines and another panelist in the plenary, said he also sees "risk of competition between nations" in the current pandemic. A race to buy up vaccine, something seen in response to the 2009 swine flu pandemic, "is the natural default setting for national governments and ministries of health, which are focused on their own domestic populations," he said.
"If they don't consciously stop and think, 'How do we coordinate globally,' the emphasis ends up on being 'How many doses of vaccine can I get?' rather than 'What can I do with the vaccine to end the pandemic?'" he said. "If the goal is ending the pandemic, which I think it is, then being very careful with what's going to be, at least through the next year, a scarce resource and very careful about how we allocate it is going to be critical," Markels said.
How broadly vaccines will be available will depend, at least in part, on how much they cost. Though clarity has yet to emerge on that point, Fauci addressed it to a degree, saying that "as much as you'd like to see fair pricing, I think to force something on a company, as opposed to working with them to try and get an understanding – particularly if the federal government helps them in the development of a product for a public health issue – that they will, in good faith, make it available to those groups, countries [and] nations that really can't afford it very well."
In a sober reminder of what's at stake, former FDA commissioner Margaret Hamburg, now foreign secretary for the National Academy of Medicine, spoke to the global nature of the issues discussed. "As long as this virus persists anywhere in this world," she said, "we all remain vulnerable."