A U.S. Senate committee met March 18 to review the federal government’s response to the COVID-19 pandemic, during which former FDA commissioner David Kessler said the Trump administration’s vaccine contracts were expensive, but effective in ensuring a robust supply. Nonetheless, Sen. Chris Murphy (D-Conn.) said one vaccine manufacturer had recently voiced an interest in charging more on a per-dose basis for its vaccine, and suggested that the cost of booster shots should perhaps be examined anew by the Biden administration.
Sen. Patty Murray (D-Wash.), who chairs the Senate Health, Education, Labor and Pensions (HELP) Committee, said the committee will draft bipartisan legislation in the coming months to act on the learnings drawn from the pandemic. Murray also observed that vaccine hesitancy is still a noticeable problem even as the daily volume of vaccinations rises, and Kessler, now the chief science officer for COVID response at the Department of Health and Human Services, remarked that Congress allowed the Trump administration to proceed at financial risk for the federal government in drawing up contracts for the vaccines, regardless of whether those vaccines would ultimately prove effective.
“Thank God for that because we are in a very fortunate position today” as a result, Kessler said, adding that it was fair to question whether any part of that approach should be replicated going forward. Officials with Pfizer Inc., of New York, had recently suggested it would charge more for its COVID vaccines when developed as booster shots, and Kessler said President Biden “believes very firmly” that vaccines should be affordable. Murphy lent his voice to that concern, stating he that intends to maintain a focus on pricing for booster shots.
Burr cites need to be ‘a better partner to the private sector’
Sen. Richard Burr (R-N.C.), the ranking member of the committee, cited the need to open the economy for global commerce in addition to opening schools and businesses, adding that “being a better partner to the private sector” is another imperative going forward. He emphasized a need for reforms at the CDC as well, stating that guidance from CDC during the course of the pandemic “has been two steps behind the data.” The CDC’s go-it-alone approach to testing in the early days of the pandemic “was arrogant and it was wrong,” Burr continued, citing the capacity offered by test developers in the private sector as evidence of a laggardly response by CDC.
Burr said a layered surveillance system is needed to help thwart future pandemics, adding that the FDA should consider retaining some features of the emergency use authorization (EUA) mechanism after the public health emergency ends. “The EUA standard calls for the benefit to outweigh the risk,” he said, adding that EUAs can be modified or rescinded should problems arise. The EUA program also emphasizes real-world evidence – which the FDA has itself emphasized in recent years – to inform those reviews, Burr noted.
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), said the variants of the SARS-CoV-2 virus present a challenge to containment efforts because some of them spread more quickly and may evade monoclonal antibodies. The situation calls for booster shots based on variant-specific vaccines, but Fauci said the vaccination rate of 2 million to 3 million administrations per day should help keep pace with the mutation-driven variants. The B.1.1.7 variant seems to respond to existing vaccines, but other variants seem to partially escape the effect of the vaccines. One helpful bit of news is that severe disease is somewhat suppressed with the new variants in vaccinated individuals, Fauci said.
Fauci was reluctant to offer a threshold for herd immunity, although 70% to 85% is a commonly cited number. Getting to herd immunity will require immunization of at least a significant portion of children and adolescents, but the different characteristics of the SARS-CoV-2 mutations make herd immunity a moving target, particularly given the differences in transmissibility.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, noted that the existing EUA vaccines were not tried against each other, adding that the Pfizer/Biontech vaccine can now be stored at more conventional refrigeration temperatures. Marks said the platforms for vaccines, such as the messenger RNA platform, may not need as much study prior to market authorization in times to come. Adaptations of a vaccine for the first couple of changes to the SARS-CoV-2 virus may require a less demanding clinical study than was needed to achieve an EUA designation from the FDA, and Marks said these studies would be mostly focused on immune response. However, there is a persistent question of matching the vaccine to the variant.
“Ultimately, the place we would like to get to is understanding which pathogens go with which platforms,” Marks said, although he indicated that the science for this is not particularly well developed as yet. Pivoting to the role of the private sector in the response to the pandemic, he said the previous shortages of vials and manufacturing equipment were overcome by an act of pure will on the part of industry, but recommended that government act to promote adoption of advanced manufacturing technologies for drugs, biologics and devices that would allow more rapid scale-up on short notice.