The May 12 Senate hearing regarding the COVID-19 pandemic included the usual conversations about contact tracing, but Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he is “cautiously optimistic” that one of the vaccines currently in trial in the U.S. will work, but that it is unlikely a vaccine will be ready by September 2020. In contrast, Assistant Secretary for Health Brett Giroir said testing capacity may reach 50 million tests per month by that time, thanks in part to the fact that antigen testing is now part of the FDA’s emergency use authorization mechanism.

Sen. Lamar Alexander (R-Tenn.), chairman of the Senate Health, Education, Labor and Pensions Committee, acknowledged that the hearing could include some rhetorical fireworks. “Such an exercise sometimes encourages finger-pointing,” Alexander said, but he added that nearly every nation across the globe “has underestimated this virus.” Alexander made note of some suggestions that the U.S. was among the best prepared nations for a pandemic, much of which was based on a 2019 report by the Global Health Security Index.

Ranking member Sen. Patty Murray (D-Wash.), was not inclined to go along, however, stating that “families around the country are counting on us for the truth” about the pandemic. “If the President isn’t telling the truth, we must, and our witnesses must,” she said, adding that the administration’s response to the pandemic “has been a disaster on its own.” Murray alleged that corruption and political interference have made it difficult for hospitals to obtain personal protective equipment, and that the White House junked a plan for reopening the economy by the CDC because the plan was overly prescriptive.

Remdesivir treatment effect modest, but NIH to ‘build on this success’

The evidence in support of remdesivir as a treatment for the SARS-CoV-2 virus is based on multiple trials, and Fauci said that while the results of the NIH study were statistically significant, the associated treatment effect was modest. “We hope to build on this success” with other monotherapies and combinations, such as the remdesivir/baricitinib trial announced May 8 by NIH, Fauci said, adding that there are other monocloncal antibodies of interest besides baricitinib.

Fauci noted that he had previously predicted a vaccine might be 12-18 months in coming, and did not disavow that forecast. Still, he noted that there are many candidates and that he hopes multiple vaccines will emerge, a scenario that would aid global availability. Vaccine may be produced at risk before completion of the underlying clinical studies, but Fauci observed that some vaccines could ultimately exacerbate the negative effects of the virus.

Giroir said the Department of Health and Human Services had identified testing capacity in various locales across the U.S. in April, and will shortly procure 135 million swabs for distribution. He said he expects a marked increase in current test volumes and a large volume of new tests, such as the antigen test by Quidel Corp., of San Diego. The FDA announced May 9 the inclusion of the Quidel antigen test to the emergency use authorization list test, and Giroir predicted the Quidel test volume would reach 300,000 tests per day “in just a few weeks.”

Giroir said that even if one assumes the current range of authorized testing technologies is fixed, the U.S. will be able to run 40 million to 50 million tests per month by the end of September. However, he noted that the addition of other technologies, including whole genome sequencing, may suggest, “that number will be much higher” in the weeks and months to come.

Fauci punches back on criticisms

Fauci rebutted the criticism of the administration’s response on several fronts, stating, “we put our foot right on the accelerator in every aspect,” including for development of vaccines and therapeutics. “I have never been told by anyone to pull back on the development” of any countermeasure or any effort related to the pandemic, he stated.

Fauci also said, “no one has ever gone from not knowing what the virus was to a phase I [vaccine] trial as fast as we did.”

“We don’t know everything about this virus, and we had better be very careful,” about reopening the economy, particularly when it comes to children, Fauci continued. He pointed to reports of an inflammatory syndrome in children that bears a resemblance to Kawasaki syndrome, although children generally seem to suffer less than adults. Despite allegations that he was described as the end-all/be-all expert on the pandemic, Fauci said, “I am very humble that I don’t know everything about this disease.”

Fauci expressed concern about the perceptions that might accompany an absence of any new cases over a 14-day period, saying that a state that jumps over checkpoints without being in a position to respond to a resurgent disease might engender “little spikes that turn into major outbreaks.” States that want to return to a state resembling normalcy must have the capacity to react to a new outbreak.

Giroir said testing needs will rise in May and June, adding that a state or local testing strategy should be designed with observed local spread in mind. Among the surveillance options listed by Giroir were pooling of samples – he said a single test could pool as many as 20 individuals’ samples – adding that wastewater sampling might be a useful way to determine whether any infections are present.

The White House has a strategy that it sees as appropriate at least through autumn, Giroir stated, noting that the administration is working with state leadership to develop economic reentry plans tailored for those states. He described industries responsible for production of swabs and other sample collection media as “non-mature” industries, in which case the administration will centrally procure the related supplies for the balance of the year for distribution to the states. Other, more mature industries do not require federal government procurement, but Giroir said the federal government can help direct these industries to deliver products to states in need, thus avoiding some of the delays incurred by the imposition of another stop in the procurement chain.

Robert Redfield, director of the CDC, said contact tracing will prove critical to efforts to corral the virus, adding that the agency is providing technical assistance to the states regarding their testing and contact tracing programs. The CDC has not yet made any hires for 30 openings provided by recent legislation, although Redfield said there are some surveillance instruments developed by the private sector that could prove useful to track outbreaks. Additional CDC guidance on reopening “will be on the [CDC] website soon,” he said.

No Comments