Senators on Tuesday pressed President Joe Biden’s top health officials to address the slowing pace of COVID-19 vaccinations as an administration adviser raised the possibility that booster shots may be needed within the next year.
“Everyone must have the opportunity to get vaccinated regardless of race, zip code, disability, primary language, or internet access,” said Senate Health, Education, Labor and Pensions Chair Patty Murray, D-Wash. “We are also seeing the vaccination rate slow — a reminder that making sure people can get vaccines is just half the battle. We need to make sure they do get them.”
Ranking member Richard M. Burr, R-N.C., also expressed worries about vaccination hesitancy.
“Maybe I was naive when this started. I thought staying out of the hospital was enough of an incentive to get a vaccine. For many people, it’s not,” Burr said. “The most challenging days may be the weeks and months ahead.”
White House chief medical adviser Anthony Fauci, Centers for Disease Control and Prevention Director Rochelle Walensky, COVID-19 vaccine development leader David Kessler, and Food and Drug Administration senior official Peter Marks acknowledged that challenges remain in the next phase.
The administration is preparing boosters for people who don't have a robust or long-lasting immune response to a typical dose, or in case variants evade protection, Kessler said.
“We are planning, and I underscore the word ‘planning,’ to have booster doses available if necessary for the American people,” Kessler said. “Increased age, the natural waning of antibodies over time, and new variants all increase the possibility that booster shots may be needed.”
Kessler said the booster shots would likely be third shots of the Pfizer and Moderna vaccines, rather than tailoring booster shots to emerging variants. But he said he needed “a couple more months” to know for sure.
Sen. Maggie Hassan, D-N.H., asked whether the next round of shots will be priced in a way that reflects billions of dollars of taxpayer investment in research and development undergirding the vaccines.
Kessler said booster shots will be free to Americans and funded by congressional appropriations through at least this year.
“For now, we are going to proceed as we have proceeded, and you have made those funds available,” Kessler.
Kessler did not address whether the federal government would leverage its investment and potential patent rights to muscle the drugmakers into promising lower prices, or whether booster shots will always be free.
Fauci defended the government's approval of the vaccines, and emphasized that years of research at the National Institutes of Health led to the development of the technology underlying the Pfizer and Moderna versions. Fauci said speed did not undercut rigor in the large clinical trials that tested their safety.
Center for Biologics Evaluation and Research Director Peter Marks, who oversees vaccines, emphasized that the requirements for an emergency use authorization for the COVID-19 vaccines were nearly as strict as for a full approval.
At the same time, Marks said the FDA was “refining” how it conducts inspections during the public health emergency, since the ability to conduct in-person inspection is more limited.
Marks said the FDA was re-examining its inspections in response to an incident with vaccine subcontractor Emergent BioSolutions that led to the cross-contamination of millions of Johnson & Johnson ingredients with AstraZeneca ingredients. That stopped vaccine production and halted exports of AstraZeneca vaccines to countries experiencing surges.
Marks said an FDA working group is still inspecting 60 million AstraZeneca doses, and wouldn’t give a timeline on their release. These doses that could be shipped to India may not pass inspection.
“We’re now working with Emergent BioSolutions to address the conditions identified,” Marks said.
Despite the problems, supply outpaces demand in the U.S., said Kessler.
But that could change in the months ahead as the White House prepares for the possibility of booster shots.
Walensky said the pandemic is waning, with the number of counties experiencing a high transmission rate at 33 percent, down from 85 percent a few months ago. But she acknowledged vaccination challenges.
“Even with this tool, while we continue to have transmission, we must maintain tools we know will prevent the spread of this epidemic,” she said.
Walensky faced bipartisan concerns over what some senators described as unclear information about the risk of contracting the virus outdoors. CDC on May 7 updated its guidance to reflect the risk of airborne transmission, which is more likely to occur indoors in poorly ventilated spaces than outdoors.
Walensky stressed the challenge of striking the right balance when circumstances vary widely nationwide.
“We at CDC are responsible for putting out guidance for . . . counties that have less than 5 cases per 100,000 [people] and counties with over 100 cases per 100,000, as well as for counties with less than 10 percent of people vaccinated, as well as for counties with over 50 percent of people vaccinated,” Walensky said.
“I always considered CDC to be the gold standard. I don’t anymore,” said Sen. Susan Collins, R-Maine, while casting CDC guidance on returning to classrooms and summer camps as overly strenuous.
Walensky appeared to get choked up, saying that she recommended her own son skip camp this year because new daily cases are still outpacing daily cases in May 2020.
“I have a 16-year-old. Every year when he comes home from camp, he writes down the number of days until he returns to camp the next year. This year it got to zero, and I told him he wasn’t going,” Walensky said. “I want our kids back in camp. We now have 38,000 new infections on average per day. Last May 11th, it was 24,000, and we sent a lot of kids home and camps were closed.”
Sen. Rand Paul, R-Ky., questioned Fauci on so-called gain of function research that can involve studying potential bioterrorism threats by developing dangerous pathogens in the lab not found in nature.
Those studies have come under scrutiny because of an ongoing global investigation into the origins of the COVID-19 pandemic. The World Health Organization says that it’s unlikely the novel coronavirus was manufactured in a lab, but its investigation faced limitations from the Chinese government and researchers acknowledged more in-depth research is needed.
“You’re fooling with Mother Nature here,” Paul said.
Paul accused the NIH of supporting a U.S. researcher working with the lab in Wuhan. Fauci insisted the U.S. expert, University of North Carolina researcher Ralph Baric, was not involved in that sort of research in China.
Baric "is not doing gain of function research, and if it is, it’s according to the guidelines and conducted in North Carolina, not in China,” Fauci said. “If you look at the grant and you look at the progress reports, it’s not gain of function.”
Fauci said he supports gathering more information on the lab in Wuhan.
“I do not have any accounting of what the Chinese may have done, and I am fully in favor of further investigation into what went on in China,” said Fauci.
The committee will likely conduct future hearings on lessons learned from the COVID-19 response, even as the pandemic loosens its grip on the U.S.
Murray also said the committee will have more hearings soon on legislation she and Burr are writing to prepare for the next pandemic.
Murray said the bill would “ensure robust public health and medical capacity to provide services to those most at risk, improve and supply the supply chain for critical medical supplies, tackle the health disparities that afflict so many of our communities and strengthen public health infrastructure and medical preparedness and response programs at every level.”