The U.S. National Institutes of Health recently announced a competitive grant opportunity for testing for the SARS-CoV-2 virus, which has been characterized as a “Shark Tank-like” program, and NIH director Francis Collins said in a May 7 Senate hearing that one of the criteria for awards is whether supplies can be made readily available for that test, the lack of which has been a significant impediment to testing in the U.S.

The NIH announced at the end of April that it had launched the Rapid Acceleration of Diagnostics, or RADx, initiative in conjunction with several other federal agencies in an effort to bolster the availability of surveillance and diagnostic testing. Among the cooperating agencies are the FDA and the Biomedical Advanced Research and Development Authority (BARDA), and Sen. Lamar Alexander (R-Tenn.) said at the outset of the May 7 hearing that the quarantine imposed on the U.S. is incurring “a terrible cost on the economy.” NIH director Francis Collins noted that the need for large-scale testing is not unprecedented, but added that previous needs for testing, such as were seen for diseases such as HIV and hepatitis C, “paled by comparison to what we need now.”

Collins also noted that an applicant tests’ demand for supplies, such as swabs and reagents, will be factored into the awards under the so-called Shark Tank program, although he noted that tests based on saliva samples may eliminate the need for swabs for at least some candidate tests. All the same, he said, “we would not want to make a major investment” in a diagnostic or surveillance test without a thorough appreciation for that test’s demands on the supply chain, and thus the participation of BARDA in the program is critical in order to “make sure you don’t end up with a success story you can’t implement.”

All of Us study may be useful in fight against COVID-19

Collins said the social distancing and other social avoidance policies have flattened the infection and mortality curves associated with the pandemic, although securing vulnerable locations such as nursing homes would require a near hermetic seal. This is because only one case can overwhelm such points of common habitation, but Collins said the All of Us study might be of considerable value in the context of the pandemic. This study has roughly 300,000 enrollees, which includes access to a sizeable volume of blood samples. “We should be able to utilize that for this and many other purposes,” Collins said.

The NIH had received 400 requests for applications in the first 24 hours of the COVID testing Shark Tank program, and 850 expressions of interest have been received. Among these, 50 applications have been reviewed so far, and Collins noted that while the clinical trial for remdesivir “is not a home run … it is a landmark.” The National Institute for Allergy and Infectious Diseases commenced a clinical study of a vaccine on March 16, and Collins said, “that trial, I’m happy to tell you, is going very well.”

“The biomedical research world is fully charged up” as well, Collins said, making reference to the industrial response to the agency’s April 17 announcement regarding a partnership with nearly 20 drug makers for therapies and vaccines. Other federal agencies are also on board with the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program, and Collins said 17 therapies have already been proposed under this program.

Collins was generally bullish about the prospect of ramping up testing capacity to a volume of millions per week, adding however that “this is a stretch goal that goes beyond what most experts believe will be possible.” He has encountered some expressions of skepticism as to the plausibility of attaining that goal, but noted that American ingenuity gives him confidence it can be done.

Murray hammers administration on response

Sen. Patty Murray (D-Wash.) who was logged into the hearing via remote conferencing, criticized the Trump administration’s response to the pandemic. Murray said “the President is still denying the severity of this crisis … and is increasingly attempting to control and silence” federal officials. This may be a reference to the fact that the White House disallowed NIAID director Anthony Fauci and others from appearing before a House committee. The Senate HELP Committee will hear from Fauci, FDA commissioner Stephen Hahn and others in a May 12 hearing.

Murray also made reference to the complaint by former BARDA director Rick Bright, who was dismissed from the position and has alleged political interference with his duties at BARDA. “We have to remember that the fight against this virus is reality, not reality television,” Murray continued, adding that the problem is not a lack of innovation, “it’s lack of leadership and a plan from this White House.” She said the $25 billion recently allocated for testing “is a good start,” but said that testing won’t fix the pandemic until those tests “are fast, free and everywhere.”

Murray attempted to grill Collins and acting BARDA director Gary Disbrow on the controversy around Bright’s dismissal, but Collins said he has no personal insight to offer, and Disbrow said the matter is now at the Office of Special Counsel and thus he cannot comment.

Collins acknowledged that the burden of COVID-19 has fallen disproportionately on the shoulders of African Americans, among others, and that some of the demonstration projects associated with the RADx program will address areas where access is unequal, paired with community outreach efforts. This will be replicated for vaccinations, and federal health officials will work through federally qualified health centers in these efforts.

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