The COVID-19 pandemic has done little to encourage bipartisan comity in Washington, and the Oct. 2 hearing of the House Select Subcommittee on the Coronavirus Crisis reflected that partisan tension. Secretary of Health and Human Services Alex Azar noted, however, that the department is doing its best to cooperate with oversight of the vaccine program by the Government Accountability Office (GAO), but that the nearly three dozen GAO requests for oversight have come at a difficult time.

The hearing took place as news that President Donald Trump and First Lady Melania Trump have tested positive for the SARS-CoV-2 virus, although his adversary in the presidential election, former vice president Joe Biden, has tested negative. Subcommittee chairman Rep. James Clyburn (D-S.C.), commenced the hearing with the statement that the Trump administration had put politics over the health of the American people. He alleged that the Trump administration refused to purchase N95 masks in the early days of the COVID-19 pandemic, adding that states had to obtain their own supplies for health care professionals in those early weeks.

Clyburn, Scalise debate the narrative

“You should have been at the helm of an ambitious national response,” Clyburn said to Azar, accusing Azar of reciting false statistics regarding the effectiveness of hydroxychloroquine. He said the Trump administration has cast a cloud of uncertainty over the validity of any vaccine the FDA might approve, and repeated the allegation that the administration has no plan to address the pandemic.

Rep. Steve Scalise (R-La.), noted that Beijing had concealed the onset of the pandemic, adding that the White House had imposed a travel ban on China at a time when such a move was criticized in the U.S. as a xenophobic policy. Scalise also pointed to several plans promulgated by the CDC, stating, “for those who choose not to read the plan, they might walk around saying there’s not a plan.”

“Just because you don’t want to read the plan doesn’t mean there isn’t a plan,” Scalise said.

Clyburn said the subcommittee had instructed GAO to evaluate the HHS’s program for vaccine development, Operation Warp Speed (OWS), one byproduct of which might be greater public confidence in any vaccine that reaches distribution. Despite Clyburn’s suggestion that HHS officials were dragging their feet on GAO’s requests, Azar said, “we are responsive,” but noted that GAO has requested a total of 32 separate audits. However, the various agencies at HHS involved in OWS are scrambling to meet the demands of the pandemic, and are doing their best to cooperate without adding excessive drag on those efforts.

Azar responded to allegations of meddling with the remark that there are debates within HHS on the science behind the pandemic. He assured committee members that any vaccine will have met U.S. FDA standards before it is released into distribution, adding that remdesivir is no longer a scarce commodity and is thus being distributed commercially again. When pressed as to whether he has advised the President’s misstatements on the pandemic and comments about the deep state at the FDA, Azar declined to characterize his private conversations with Trump, including on the relative absence of use of N95 masks by those in attendance at Trump’s campaign rallies.

Clyburn said the U.S. ranks 142nd of 150 nations in terms of fatalities per million, and Azar responded that Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, was one of several officials who had predicted that 2 million Americans might lose their lives to the SARS-CoV-2 virus. There are several ways of measuring fatalities, including excess mortality, which from March to July was 37% lower in the U.S. than in Europe for those aged 65 and older, Azar said.

Regarding the Aug. 24 CDC guidance on testing, Azar said the agency had not recommended against testing for those who are asymptomatic, but was instead attempting to convey that anyone who has been in close proximity with someone who has tested positive do not themselves necessarily need to be tested immediately. Azar said one of the concerns was that some who have been thus exposed might believe that a test undertaken in the first couple of days after that exposure might suggest they are in the clear despite that infections are often undetectable until after five days.

BIO presses Azar on FDA vaccine guidance

The FDA’s initial guidance regarding vaccine development had called for a 50% efficacy rate with some fairly specific enrollment requirements, but the agency has not yet issued a guidance for emergency use authorization of a vaccine. That gap was the subject of an Oct. 1 letter from the Biotechnology Innovation Organization (BIO) to HHS Secretary Alex Azar, pleading that the FDA make public “all new guidances” that might play a role in vaccine development.

President Trump had suggested in the last week of September that any vaccine EUA policy would need a scrub-down in the Oval Office, a statement he made shortly after FDA commissioner Stephen Hahn had testified at a congressional hearing. Hahn had advised the Senate Health, Education, Labor and Pensions Committee that any EUA policy for a vaccine would require data from at least one randomized, controlled trial suggestive of an acceptable level of safety and efficacy. Trump characterized the need for a guidance and an advisory hearing for any vaccines as “a political move” on the part of FDA staff.

Michelle McMurry-Heath, president and CEO of BIO, said in the letter to Azar that the release of any and all vaccine-related guidances would both provide scientists with greater clarity and bolster public confidence in any eventual vaccine. McMurry-Heath said vaccine developers were “encouraged to learn the FDA has been finalizing new guidance” to spell out the safety and efficacy benchmarks needed for an EUA, but said these documents must be shared with those “on the front lines developing potential vaccines.”

However, those guidances “must also be shared more broadly with the American public,” McMurry-Heath said, adding, “we cannot allow a lack of transparency to undermine confidence in the vaccine development process.”