U.S. flunking pandemic fire drill

Former BARDA Director Bright warns U.S. isn’t taking steps to counter possible H5N1 outbreak

The U.S. is experiencing events that are either the first stages of a widespread avian influenza outbreak or a fire drill that will show how well the nation is prepared for an outbreak. The U.S. has not stepped up to meet the challenge, Rick Bright, the former director of BARDA, told BioCentury.

In an interview with The BioCentury Show, Bright said there are opportunities for biotech companies to help fill voids in surveillance, point-of-care diagnostics, vaccines and therapeutics. The federal government must provide leadership and funding to unleash industry, but it has acted slowly and hasn’t taken the necessary initiative, Bright said. Bright is now founder and CEO of Bright Global Health.

Avian influenza, H5N1, has led to the deaths of hundreds of millions of birds, either killed by the virus or culled to prevent its spread, over the past three years. Public health officials have been warning that the virus, which has a high fatality rate, could mutate and infect mammals, including humans, and then evolve human-to-human transmissibility.

The first steps in that chain of events have happened.

In March, H5N1 was detected in cows in Texas, Kansas and New Mexico. The virus has also spread to mice, foxes, cats and other mammals.

At least three farm workers in the U.S. have been infected. There has been little testing, so more people may have been infected.

“We’re in the dark on this outbreak,” Bright said. “We don’t know where this virus came from,” including whether it started with a single wild bird infecting a cow, or if there are ongoing introductions from additional wild birds infecting cows.

“We don’t know how broadly this has spread because we don’t have surveillance testing being done in animals,” Bright said. “And we don’t have surveillance testing being done in people on the farms or even close contacts of those who are infected.”

He added that “one of the challenges that we’re learning about as the outbreak continues is there’s a reluctance for farmworkers and sometimes farm operators or owners to let the federal government” test people and animals.

“We’re not getting the data we need,” Bright said. “We’re flying in the dark. To me, that’s an innovation opportunity” that he would have focused on if he were still heading BARDA. “There’s a gap in our testing technologies that allow us to test more people and maybe do it in a more private way or more anonymous way.”

Bright stressed the need for government to become more actively and creatively involved in addressing the threat. Even if this outbreak fizzles, a future outbreak is very likely, so steps taken now will not be wasted even if they aren’t immediately deployed.

“The government needs to invest” in point-of-care diagnostics, Bright said. “Entrepreneurs will respond if the government makes money available.” A rapid test that can be used in homes that could detect H5N1, or simply distinguish between H5 and influenza A, would be valuable because responses, including treatment, are quite different. Individuals infected with H5 need to be treated more urgently, and it is likely that they’ll need to receive higher doses of antiviral drugs for longer periods of time, he said.

There is an urgent need for the government to invest in the development of H5N1 vaccines that are not produced in chicken eggs, including mRNA-based vaccines, Bright said. “We’re hearing from some test developers and some vaccine developers that indicated they would assume some of the risk and make some of the investment, or their investors would jump in now, as long as there was some commitment from the government to procure or buy those tests or those vaccines when they’re ready.”

Tests and vaccines are not going to be sufficient. There is also an urgent need to develop new therapeutics, especially because the H5N1 virus is likely to evolve resistance to existing antiviral drugs, Bright said. This need goes beyond antivirals. Government and industry, Bright believes, should be investing in drugs that treat the inflammatory symptoms of influenza.

Just as it did during the COVID-19 pandemic, FDA should dedicate resources to streamlining the regulatory process for H5N1 countermeasures, he added.

All of the necessary steps will require attention from members of Congress, including those who are wary of any attempt to prioritize public health. “I don’t think many on Capitol Hill really appreciate the need to close the gaps,” to move proactively to “respond to something as rapidly moving and potentially fatal as influenza and pandemic influenza,” Bright said.