Some causes for hope

Beyond the curve: Dr. Peter Lurie's COVID-19 blog

It may be early days yet, but just this morning there are some signs of progress on the COVID-19 front.

First, the Biden transition team announced the members of its COVID-19 task force. Three physicians are at the helm: CSPI Board Chair David Kessler, former Surgeon General Vivek Murthy, and Yale University Associate Dean for Health Equity Research Marcella Nunez-Smith. The rest of the task force members bring long histories of technical expertise, covering the full range of skills that will be required to address head on the many-headed hydra that is the pandemic. There’s Michael Osterholm, a leading epidemiologist and director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Rick Bright, who filed a whistleblower complaint against the current administration after he resisted widespread availability of hydroxychloroquine, and Luciana Borio, an expert in pandemic preparedness with whom I worked at FDA. There’s also Eric Goosby, a former United States Global AIDS Coordinator, and Zeke Emanuel, a former Obama administration health policy adviser now at the University of Pennsylvania.

The new administration already has produced a plan, which contains the essential elements of an effective response to the pandemic:

Ensuring that public health decisions are made by public health professionals
Make testing widely available and free
Giving all frontline workers high-quality and appropriate personal protective equipment
Directing the Occupational Safety and Health Administration (OSHA) to keep frontline workers safe by issuing an Emergency Temporary Standard
Accelerating the development of treatments, rapid diagnostic tests, and vaccines
Instructing the CDC to provide clear, stepwise guidance about containment and mitigation in local school districts, health care facilities, higher education, and for the general public
Providing guaranteed emergency paid sick leave and care-giving leave
Expanding the Supplemental Nutrition Assistance Program (SNAP) for the duration of the crisis
Providing explicit authority for the HHS Secretary to approve the commercial price of vaccines that are developed with federally funded research
Immediately restoring the White House National Security Council Directorate for Global Health Security and Biodefense
Fully funding the World Health Organization

Elsewhere, the incoming administration has indicated that it would mandate masks on federal property and use federal transit law to require masks on public transportation. The administration could also approach governors to issue their own mask mandates.

Much of this is consistent with approaches CSPI has advocated, including in this blog.

Second came the striking news of claimed effectiveness of the Pfizer/BioNTech vaccine. According to a company press release, the vaccine produced a 90% reduction in new COVID-19 cases. The press release provides little additional information, and so we should all withhold final judgment until more data are provided (How many cases were in the treated and placebo groups? How serious were the cases? How many people have been followed in the trial and for how long? How big is the vaccine’s safety database and what does it show?). But the vaccine candidate, based on mRNA technology also used in Moderna’s vaccine, has the potential to be a breakthrough in our management of the current crisis. Indeed, the 90% efficacy claimed is well beyond the minimum FDA had stated it would require.

But, if corroborated, the challenges only begin there. The vaccine will require refrigeration, a challenge during transport, especially to resource-poor countries. And Pfizer, which pointedly declined support from Operation Warp Speed, may not be subject to the same constraints upon pricing that those who signed up for the program might feel obligated to follow.

And then there is the matter of convincing an increasingly skeptical public to agree to vaccination, a skepticism fostered in significant part by comments from President Trump about vaccine availability prior to the election, leading many to conclude that the vaccine approval process was being politicized.

But today is a brighter day. And as the scientific and regulatory processes unfold, we will soon know how bright.