A plan by the Biden administration to spend some $5 billion to jump-start efforts to develop new coronavirus vaccines and treatments is drawing kudos from scientists and pandemic experts.
Project Next Gen would be a successor to Operation Warp Speed, which funneled at least $18 billion to drug and biotech companies to quickly develop vaccines and monoclonal antibodies that were used to great success during the initial, acute phases of the COVID-19 pandemic.
But now, as COVID edges toward becoming endemic, a different strategy is needed. Current vaccines offer only short-term protection, and monoclonal antibodies have lost effectiveness, leaving especially the immunocompromised and seniors unprotected, say experts.
The plan — first revealed by The Washington Post — reportedly will have three priorities:
· Creating improved monoclonal antibodies;
· Developing vaccines — such as nasal vaccines — that can boost mucosal immunity and potentially better prevent transmission;
· Developing a "universal" or pan-coronavirus vaccine that could target SARS-CoV-2 variants and potentially other coronaviruses
"Those are important priorities," said Amesh Adalja, MD, senior scholar at the Johns Hopkins Center for Health Security at the Bloomberg School of Public Health. Having federal leadership and dollars is necessary, but "it's important to recognize this is going to augment what's already going on in the private sector."
He notes, for instance, the development of ensitrelvir (Xocova), an oral anti-COVID protease inhibitor, which has been approved in Japan. The manufacturer, Shionogi & Co Ltd, will be seeking approval in the US also. Still, there's less private investment in those and other products for infectious diseases, Adalja said. "There are so many other investments that companies may want to engage in that are less risky, less fraught with uncertainty, in which there's just more market predictability and demand."
He pointed out the monoclonal antibodies that were initially effective but were rendered ineffective by COVID variants: sotrovimab (Vir and GlaxoSmithKline); bebtelovimab and the combos of bamlanivimab and etesevimab (Eli Lilly); casirivimab and imdevimab (Regeneron); and tixagevimab and cilgavimab (Evusheld, AstraZeneca).
"If you were a monoclonal antibody company, COVID is probably not what you want to be investing in, because they all had one moment in the sun before a variant overcame them," Adalja said.
There have been calls from many experts for a program that is focused on a new generation of coronavirus vaccines, antibodies, and antivirals, especially as it has become increasingly clear that current vaccines do not prevent transmission or offer long-term protection.
"We can't give people boosters every 4 or 5 months. That's just not sustainable," said Bruce Gellin, MD, MPH, chief of Global Public Health Strategy for the Rockefeller Foundation's pandemic prevention initiative. Developing vaccines that can prevent transmission would be a game-changer, Gellin said, "but that may be a scientific challenge that we're going to take awhile to tackle."
Vaccines also need to offer broader protection, "and that's broad protection against not only the viruses we see now but those that haven't emerged yet," he said. Noting the difficulties in developing influenza and HIV vaccines, Gellin said it's hard to predict how long it will take to develop a universal coronavirus vaccine. Progress "will be iterative and incremental."
Coronavirus outbreaks — whether driven by variants or new strains — are going to continue, said Gellin. "I'm not a bat virologist, but if you look into that literature, there are a lot of other coronaviruses, and I think the recognition is that one of those could cause trouble in a different way in the future. So, we better learn all we can about how these viruses do what they do and how to prevent them from doing that." Finding new vaccines and therapeutics is crucial, he said. "We need to stick with it. Just because the pandemic isn't as aggressive as it was a year ago doesn't mean we don't need these products for some time in the future.
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