Politics. The collision of “global health” and domestic priorities, even slightly faux ones, was an inevitability. Forget all the one-worlders talk from the pharmaceutical industry when PFE CEO Albert Bourla declared “Pfizer and BioNTech have been firmly committed to equitable and affordable access of COVID-19 vaccines for people around the world.” Job one for the White House, with the gleeful participation of the pharmaceutical industry, is to get COVID-19 boosters approved and administered in the U.S.
From their cushy sinecures in Geneva, the “global health” world is aghast. A finite amount of manufacturing capacity will be dedicated to limiting infection and mild illness while much of the world is exposed to severe illness and death. Although PFE and MRNA appear to be meeting the terms of their contracts in the US, they are well behind commitments to COVAX. Vaccination rates in low- and moderate-income countries are, with a few exceptions, in the single to mid-double digits.
Like all things political, there is a broader agenda. The “global health” community is agitating for technology transfer of mRNA manufacturing processes, something to which neither the pharmaceutical industry nor the White House is likely to agree. The White House, meanwhile, needs to get ahead of outbreaks that are an inevitability as the days get shorter and colder. The narrative that reprobate governors of southern states are to blame will lose its credibility as cases rise, like they are in Vermont, one of the most highly vaccinated states in the country.
Not to be too cynical, but another factor could be the White House’s pursuit of a national industrial policy that aspires to reverse a good bit of the globalization on which U.S. supply chains have depended the last several decades. Globalization is coming to a screeching halt and with it an interest in “global health.”
If so, it will be a stunning outcome with prolonged implications for critical supply chains.
Policy. As one of the health policy Twitterati put it, “Peter Marks has the look of a man that needs to deliver a [booster] approval no matter what.” Marks, the FDA official presiding over the Vaccine and Biological Products Advisory Committee on Friday met with stout resistance from the public and committee members but managed to eke out enough consensus on limited booster approval for the headlines.
There were a few concerns. First, the FDA’s briefing document was not exactly a hearty endorsement, leaving many questions unanswered. Advocates for greater international distribution were out in force. So too where participants who questioned whether the incremental benefit of limiting severe disease among the least affected – the young – was worth the small risk of adverse effects. In other words, can the U.S. not tolerate some infection if it does not result in hospitalization and death?
In the end, the AdComm agreed that certain vulnerable populations such as those regularly exposed to the unvaccinated, like teachers, and people over 65 should receive the booster. They plan to wait to consider other populations until more data is available.
The FDA itself does not have to accept the AdComm’s recommendations. In this case, they are likely to take the modest win, stretch the interpretation of vulnerable as far as they can, and wait until more information is available.
Not what the White House wants but, given the growing public skepticism over the competence of the federal government’s scientific agencies, probably what it needs.
Power. What has become evident even before you read former FDA Commissioner, Scott Gottlieb’s book, Uncontrolled Spread, is that policy making – the slow and fine art of identifying problems, digging into the available arsenal of solutions and executing in a fair and rational way – has been absent from Washington for some time.
Gottlieb gives the example of the 6 feet that defines social distancing today. There is no mention of any distance in the World Health Organization’s Nonpharmaceutical Interventions for Pandemic Influenza, International Measures, 2006. Instead, it is defined as cancellation of mass gatherings and select school closures. Gottlieb says the 6 feet of distance was a compromise between the White House and the CDC which was recommending 10 feet; a completely arbitrary outcome.
The absence of policy development capacity – tragic because sitting at the CDC were several guidance documents meant to support a pandemic response - left both White Houses the victim of whatever narrative developed from political opposition, social media campaigns and all manner of sketchy groups looking to “reset capitalism.” Worse, it was left to interested parties to solve the dilemma of the day.
When “do more testing” erupted as a political mantra, the White House was forced to turn to the only place with scale for an answer, DGX and LH. Both companies have come to define the testing response. The accurate but cumbersome and unpleasant PCR test now defines the pandemic’s ebbs and flows. The imperfect but still useful rapid antigen test was left behind as were other valuable tools like genetic sequencing of strains and serology testing to determine immunity of local populations.
The latest is the booster debate. As breakthrough infections have appeared in even heavily vaccinated counties like Miami-Dade, the White House and others have sought an explanation, and more important, a response. President Biden, after all, ran on “beating the virus.” With his approval ratings in a ditch and winter coming on, he had no choice but to discuss with Albert Bourla a solution that of course included more PFE vaccines.
Voila! Boosters will be widely available by tomorrow!
It is with that the scientific community decided it was time to save their professional and the broader government function of policy making. Too late for most things but welcome nonetheless regardless of their ultimate agenda.
Have a great rest of your weekend.
Emily Evans
Managing Director – Health Policy
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