No time to wait on development of second-generation vaccines

Congress returns to Capitol Hill this week, and among the most important unfinished business on its agenda is agreeing to a new package to fight COVID-19 by funding second-generation vaccine research. When Congress left town, there was cautious optimism that a deal was close.

It is imperative Congress reach a bipartisan solution to a problem that still poses a deadly threat to Americans. As the Washington Post has reported, officials are “monitoring the spread of new, highly transmissible versions of the omicron variant in New York state and Europe, the latest evidence of the coronavirus’s ability to overhaul its genetic profile and pose a fresh threat.”

If Congress acts — and is clear that the funding must make it to agencies like the Biomedical Advanced Research and Development Authority (BARDA) for vaccine research and not allow it to be diverted — Congress and the president can take credit for accelerating the next generation of COVID-19 vaccines that Americans need.

BARDA formally suspended the review and support for vaccine development programs in August 2020 because it didn’t have the money to fund new programs. These essential activities remain closed, and the federal government has not supported additional advanced development of COVID-19 vaccines since Operation Warp Speed.

Karen Bok, the Director of Pandemic Preparedness and Emergency Response at the National Institute of Allergy and Infectious Diseases, told the Post, “We could Operation Warp Speed the next-generation mucosal vaccines, but we don’t have funding to do it. ”

If BARDA were open for business, it could evaluate an array of second-generation vaccine candidate possibilities that include a pill, nasal sprays, live-virus vaccines and other options that could provide mucosal protection.

While Congress was in recess, COVID-19 continued to charge ahead.

In Britain, France and Germany, case numbers are climbing as an even more contagious subvariant of Omicron, known as BA.2, takes hold.

Communities around Syracuse, N.Y., and Lake Ontario are already contending with the new omicron subvariants, dubbed BA.2.12 and BA.2.12.1. New York state officials say the subvariants are spreading 23-27 percent more rapidly than the original BA.2 omicron variant and that the subvariants are contributing to rising case numbers.

Many scientists expect other emerging COVID-19 variants to hit the U.S. Not only has the virus mutated to create new variants, the virus has also shown that it can recombine to make new and more infectious variants — in this case, a chimera of the delta and omicron variants. This entirely new form of generating new variants is expected to further confound our immunity and society.

“There are so many things we could be doing, yet the United States has time and time again chosen to be reactive, rather than proactive, and that has cost us dearly,” said Anne Rimoin, an epidemiologist at the UCLA. “We’ve been wearing rose-colored glasses instead of correcting our vision.”

And Johns Hopkins University epidemiologist Jennifer Nuzzo said, “You use the quiet periods to do the hard work. You don’t use the quiet to forget.”

Now is no time to forget that while first-generation COVID-19 vaccines have reduced deaths, serious illness and hospital admissions, they have not ended the pandemic. They have shown limited success in preventing forward transmission from vaccinated people after a breakthrough infection or reinfection.

They require booster shots to maintain immunity, even as there is increasing evidence that boosters have limited positive effects and may be insufficient for the estimated 10 million immunocompromised patients in the United States.

Last week, the CDC’s Advisory Committee on Immunization Practices largely agreed that repeated use of boosters was not a realistic solution to the current crop of COVID-19 shots.

“With the vaccines currently available, we should not chase the rainbows of hoping that those vaccines could prevent infection, transmission and even mild disease because we’ve learned that is just not possible,” it said.

America needs Congress to fund second-generation vaccines. In addition, America needs the executive branch to empower BARDA to reenter its successful collaboration with industry and ensure sufficient funding is provided to support additional vaccine development programs.

We — three biotech chief executives — recently wrote to U.S. Department of Health and Human Services Secretary Xavier Becerra to emphasize the urgency of developing a second generation of COVID-19 vaccines and ensuring that funding for this makes its way to BARDA and other agencies charged with fostering vaccine development.

In a recent New York Times essay, Bill Gates argued that we need to bring more vaccines and treatments to market faster. We can’t agree more.

If a new wave of COVID-19 hits and our leaders have done nothing to prepare, if we are still chasing rainbows and not moving second-generation vaccines to market faster, Americans will be rightfully furious. They want bipartisan cooperation, clear-eyed leadership and strong action. They want second-generation vaccines because they know COVID-19 is not done with us yet.

Andrei Floroiu is the CEO of Vaxart, Inc., a biotech company in San Francisco; David Dodd is the CEO of GeoVax, a biotech company in Atlanta; Seth Lederman is the CEO of Tonix Pharmaceuticals, a biotech company in Chatham, N.J.