U.S. lawmakers warned to prepare for worse days ahead in pandemic

While the Biden administration's America Rescue Plan began its journey through Congress Feb. 3 as the next U.S. effort to address the COVID-19 pandemic, lawmakers came together to identify steps to improve vaccine distribution and curb ongoing supply shortages.

Testifying before the House Energy and Commerce Subcommittee on Health, Luciana Borio, vice president of In-Q-Tel and a former acting chief scientist at the FDA, warned that the worst days may lie ahead, given the emergence of variants, especially the South African variant that seems to cause more severe disease.

Due to the "lack of a robust, large-scale national genomic surveillance system to monitor viral evolution and spread . . . we are flying blind with respect to detecting the introduction or emergence of new variants or monitoring their geographic spread," she said.

The threat of variants won't be resolved with travel restrictions, and small businesses can't afford another lockdown, Borio said as she stressed the need for behavioral changes, sequencing to detect variants and the development of new therapies.

"This is not going to be the last biological pandemic [and] COVID is likely going to become endemic," Borio said.

Subcommittee Chair Anna Eshoo noted that the administration's plan would provide the resources to vaccinate 300 million Americans by the end of the summer. She asked Borio how the emergence of variants might affect that plan.

"In the short term, nothing really changes," Borio said. But in the midterm, efforts will be needed to prepare to manufacture new vaccine candidates if there's an erosion in protection. And there will need to be FDA guidance on the recruitment challenge for large vaccine trials after millions of Americans have been vaccinated. Borio added that she expected COVID-19 vaccines will need to be boosted periodically.

While the witnesses and subcommittee members were encouraged by the rapid development of safe and effective vaccines, they all recognized a lot more work needs to be done. Borio stressed the need for more COVID-19 therapies. She said the few drugs authorized for use are difficult to scale and to administer and they are limited in benefit, in whom they work and when they work in the infection lifecycle.

"We . . . need treatments that are more easily administered, more easily scalable to manufacture, more easily accessible," she said. Another item on her list is the urgent need for a research program that comprehensively tackles the coronavirus.

Testing shortcomings

Borio also pointed out the shortcomings of the current testing strategy, as many Americans don't have access to testing or they have to wait days for results. Since the authorized treatments work only in earlier stages of COVID-19, the inability to get rapid test results limits the use of those treatments, she said.

Rep. Kim Schrier (D-Wash.), a pediatrician new to the subcommittee, said the most effective testing program would be daily use of in-home antigen tests, but the $25 to $50 price of such tests is an obstacle to daily use. She suggested a head-to-head comparison of the tests and then government procurement of the most effective one at a price more reflective of the cost of producing them – less than $1 per test.

But then there are the supply issues to deal with. Rep. Frank Pallone (D-N.J.), chair of the Energy and Commerce Committee, said testing supplies, such as reagents and swabs, remain in short supply, as does personal protection equipment (PPE).

To address such shortages, the U.S. needs to invest in sustained domestic manufacturing across the entire health care supply chain and prevent foreign interests from undercutting U.S. suppliers, said Greg Burel, president of Hamilton Grace and former director of the U.S. Strategic National Stockpile.

Pallone acknowledged that the U.S. has had to rely too much on China and other countries for supplies and drug ingredients during the pandemic. He said the government must plan for future pandemics in the same way that it plans for the annual flu season.

There are U.S. companies willing to develop the needed supply manufacturing capabilities, but before they invest, they have to know it will be a sustainable market, Burel said. Based on past experience, there's concern that as the current crisis abates so will the urgency for sustaining the nation's preparedness, he said.

He urged Congress to continue to incentivize manufacturers to ensure domestic production of medical supplies that will be needed in the next public health emergency.

Michael Leavitt, former secretary of Health and Human Services and former governor of Utah, said Congress should consider such public health funding the cost of preparedness.

Eshoo agreed that a stockpile of American-produced products is necessary. Being dependent on other countries is an embarrassment, she said, adding that both sides of the aisle care about that issue.

In opening the hearing, Eshoo previewed the America Rescue Plan that was to be introduced on the House floor later in the day. In addition to $20 billion for a national vaccine strategy that would increase the supply and the number of vaccine administration sites, the legislation includes $10 billion to expand the domestic manufacture of medical supplies. It also calls for funding for genetic sequencing to detect emerging new variants and for more research and the large-scale clinical trials needed to develop new therapies. "I think that's music to all of our ears," Eshoo said.