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Takeaway: The extraordinary achievements in vaccine development and likely approval are running headlong into political forces

Editor's Note: This is a complimentary research note published by Healthcare Policy analyst Emily Evans. CLICK HERE to get COVID-19 analysis and alerts from our research team and access our related webcasts.

The Vaccine Wars | Politics, Policy & Power - 10 26 2020 10 32 02 AM

Politics 

Mario Cuomo once famously said, "campaign in poetry but govern in prose."

If Thursday night's debate here in Nashville was any indication, the quality of the poetry in Campaign 2020 is little better than a rugby team's limerick, made worse by two of the most inarticulate candidates in American politics.

Despite's the U.S.'s extraordinary leadership in coronavirus vaccine development, the president failed to provide the sweeping narrative of careful planning, aggressive mobilization and unequal innovation that a more silver-tongued candidate would have relished.

The moment in the debate came when the moderator asked about "enough Americans" getting vaccinated and called into question President Trump's claims that it would be possible this fall.

It was the perfect opportunity to tell the world that Phase I trials were launched in March because of Pandemic Preparedness and Response plans put in place a decade ago; that the U.S. was assuming significant financial risk in exchange for speed as advanced manufacturing was stood up before vaccine approval; and that so much of that speed was made possible by research on coronavirus that anticipated it as a source of pandemic. 

Instead, the president ignored the nuance of "enough Americans" which implied widespread availability and defended his claim that a vaccine would be distributed in the fall.

Swing and miss.

If you follow the efforts at NIH, FDA and CDC on the coronavirus vaccine, all 150 of you know the president is right. A vaccine is very likely to be available this fall. You also know that widespread availability will not be a reality until late 1Q 2021 or early 2Q 2021. Health care workers, particularly those at long-term care facilities, will be inoculated first.

A significant source of COVID-19 mortality has been long-term care facilities, particularly early in the outbreak in the northeast. A phased roll-out of the vaccine, while made necessary by manufacturing, administration and other logistic realities, will still almost immediately bring relief. Protection of the vulnerable, to greater and lesser extents, has formed the basis for many community responses. Mayors and school boards across the U.S. have argued that in-person learning was not possible as long as children could spread the virus to the frail. Gatherings such as those for funerals and wedding have, in most communities, been suspended and supported by the argument that grandmothers and grandfathers would be at risk.

It was a perfect opportunity for the president to claim championship of the frail and the weak and a return to normalcy, all while taking a jab at governors whose initial management of the crisis contributed, in part, to their state's death statistics.

Strike Two.

The second group of people to whom the vaccine is likely to be delivered are critical infrastructure workers like those in food processing, agriculture and transportation. These industries have also been significant sources of disease spread due to the living and working conditions of the employed. It is workers like these, whose jobs require not just their hands but every other limb and a strong back, that are partially responsible for elevating Donald Trump to the White House.

Questions about a phased roll-out of a vaccine was a perfect opportunity to demonstrate that, for once, those frequently forgotten by the political and business elite were moving to the front of America's line.

The president ignored an opportunity to hold out those a pastor friend of mine refers to as "the least, the lowest and the left behind" as special; important to the future of the country. Instead he seemed to imply that the vaccine would be ready for most Americans almost immediately.

While there are many prognostications that Donald Trump may lose in November because he never grew his base, the debate performance Thursday suggests perhaps he tried. He just isn't very good at it.

Out.

The Vaccine Wars | Politics, Policy & Power - 20201025P3

Policy

Ironically, the same day as the debate, the Food and Drug Administration's Vaccine and Related Biologics Advisory Committee held a meeting to discuss the process for approving a vaccine for the SARS-CoV-2 virus and follow-on considerations.

Originally, this meeting was billed as a review of some data on vaccine candidates currently in development. In September, however, FDA Commissioner, Stephen Hahn announced it would be a more general discussion about the process and post-licensure or EUA approval monitoring.

On Thursday at 12:30 ET, Josh Trantum, Ph.D. and I will be discussing the meeting, its messages, timing and what we think the next few months will look like. Josh has extensive experience sourcing, licensing and developing pre-clinical biopharmaceutical assets in a broad range of therapeutic categories and disease areas. Please reach out to sales@hedgeye.com for further inquiries. 

He also holds an adjunct appointment as an assistant professor in Biomedical Engineering at the Vanderbilt University School of Engineering. You will want to tune in because Josh is great at translating scientific discovery into investment opportunity, something he does each day at his life sciences fund, Curex Capital. 

I don't want to steal his or my thunder, but I will note one theme of the FDA meeting was the always present, but certainly now elevated, importance of public trust. This Committee's presentations and subsequent discussion focused on why the current pace of development and approval was possible, efficacy standards and post-approval monitoring.

To their great credit the vaccine community has moved aggressively to combat the politicization of an EUA's timing and the FDA has put itself firmly in charge of the process, much to the consternation of the "political people" in the White House and at the Humphrey Building, the brutalist structure that houses H.H.S. in Washington.

Power 

The "political people" in Sacramento and Albany are having none of the FDA's trust fall exercise with the American people.

Governor Gavin Newsom, last week, followed Governor Andrew Cuomo in announcing California would not accept approval by the FDA as evidence that a COVID-19 vaccine was safe. A few other governors have made similar announcements.

In another hopeful sign that sanity may be breaking out, the response was bi/non-partisan and critical. Saturday morning, Senate HELP Committee chairman Lamar Alexander released a statement after a floor speech asking the Governors to stop second guessing the FDA's career scientists.

Academics from Duke to Yale echoed Senator Alexander's concerns and pointed out that it would be nearly impossible to replicate the FDAs review process. There are simply not enough vaccine experts to go around and most of them can be found at or working with the FDA.

The likely result is to sow confusion in the already muddled American mind. While some in the public health community have pointed to the Governor's announcement as evidence of lost trust in the FDA, those of us in politics see it for what it is: political grandstanding to serve career objectives. Polling on the safety of a COVID-19 vaccine is below 50% and nothing appeals to a political leader more than riding to the rescue.

There is also little downside. Medicaid, for example, must pay for most FDA approved drugs, biologics and drugs. Past efforts by states to limit distribution of FDA approved drugs has been blocked by the courts. 

Public health is written in prose and these governors prefer poetry as they prepare for 2024.