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Sunday, October 17, 2021

Departures from the FDA

Are we following the science, or not? While we all (I think) appreciate the many scientific minds that brought us a SARS-CoV-2 vaccine in less than a year, see, Future's so Bright (February 2021), there are a fair few now who find little to trust in the scientists we see on television and in the press. I overhear much criticism and distrust for the physicians featured on news shows. It is possible that Bill Nye, the Science Guy, is the last best hope for a credible public discourse on the science of COVID-19 (facetious, but not by much).

The British Broadcasting Corporation (BBC) noted last week
"While tens of millions of US residents are already eligible for a third jab, Americans across the country remain confused about boosters, who needs them and how they help."
The authors seem sympathetic with those who struggle to keep up with the persistent shifts in the recommendations, mandates, and more. Like the press that insists on discussing "legal marijuana," perhaps some portion of the blame lies with the terminology that the press chooses ("third"). See Mischaracterizing Pot Again (February 2020). One American is quoted by the BBC:
"Of course, I'm confused. On one day the White House said that they'd give boosters to everyone. It turns out only some people can get them. I still don't know who decides . . . . "It seems to me there's been a lot of contradictions."
Some suggest that referring to a "third jab" is problematic. Fifteen million Americans have taken the Johnson and Johnson vaccine. That is delivered in one dose. Those people never had a "second jab," and referring to what comes next as a "third jab" is apparently not so clear to them. One physician even suggests that SARS-CoV-2 is here to stay and that we will all be getting annual shots, as we do for the influenza virus. Are we going to keep using numbers and try to track (in 2025) that we are on our own personal "sixth jab" or similar? Would the generic "booster" ease comprehension?

The news last week is that the Moderna and J&J vaccinations are now recommended for approval for "booster" shots. That simply means that if you are "fully vaccinated" with any of the three potentials (Pfizer, Moderna, J&J), you may soon be able to get an additional shot that is intended to enhance your personal protection; a "booster." 

For those who received Pfizer, the "booster" will be available for:
"older adults and 50 to 64 year-olds with medical conditions, as well as adults with underlying medical conditions or those who live and work in high-risk settings."
For those who received Moderna, the "booster" will be:
"a single half-dose booster for the elderly, the immunocompromised or those in high-risk jobs or living situations."
For those who received J&J, the "booster" will be:
"given to anyone over 18, at least two months after the initial dose."
And, some expressed that the J&J should be shifted to a two-dose initial inoculation for all who elect that brand. How was it ever decided that this one is one and that one is two? This one is two followed by a third, but that one is two followed by a half? How, why, what, explains the science to us? Were there trials, tests, and experiments? Is the protection we have degraded? How extensive or deteriorated is our protection? Does it matter if we also were infected/recovered at some point? Is there science? Or, have a number of really smart people just reached a consensus?

These are the recommendations of the Food and Drug Administration as of mid-October 2021. The recommendations are a challenge. For example, at the time the "booster" recommendations were made last week regarding Moderna and J&J, 9,800 Americans had already had a J&J "booster." Of more interest, in terms of magnitude, is that 1.5 million had already had a Moderna "booster." Unapproved? The FDA, per the news, is recommending that "boosters" be allowed, encouraged, and provided, but it appears that "boosters" are not all that uncommon already, approved or not. Perhaps we don't need Bill Nye as much as we need some simple, straight, answers?

There are some in the scientific community, affiliated with groups such as the Food and Drug Administration (FDA) and the World Health Organization who conclude that "the current evidence on Covid-19 vaccines does not appear to support a need for booster shots in the general public right now." They published their thoughts recently in The Lancet. This is discussed in a recent post Show me the Science (September 2021). OK, if there is no evidence for "boosters," does that mean all of this is a battle of consensus? Is there science? Why the "right now" in that sentence? Does that mean we (the vaccinated) do not scientifically need a "booster" or that we do need it but others need an initial dose more? Where does the science end and the sociology begin?

That "not now" position or conclusion from "the medical journal The Lancet," was recently discussed by CNN. Among the authors of this paper are "two senior FDA vaccine leaders." Apparently, in August, the FDA announced these two "will be stepping down in October and November." CNN notes that this "sparked questions about whether the departures would affect the agency's work." Perhaps their departure might cause one to question why they are leaving? Is it voluntary, is it related to their seeming disagreement with the political promises of impending "boosters for all" last August?

The best news in the Lancet paper is that "randomized trials and observational studies on COVID-19 vaccines" led them to conclude the vaccine is effective and "substantially protective against severe disease from all the main viral variants." With all of the press that Delta is getting, that is reassuring. Notably, however, "the efficacy of most vaccines against symptomatic disease is somewhat less for the Delta variant than for the alpha variant." Thus, there is reason to remain cautious and careful despite vaccination status. However, it is undeniable that the efficacy of these vaccines is admirable and beneficial to each of us (personal), and therefore to all of us (societal). But, are there similarly "randomized trials" to prove I do or do not need a "booster?" (as in now, not later).

The CNN article supports that sociology is at work in some of the analyses. The authors "argue in their paper that the current Covid-19 vaccine supply could 'save more lives' if used in people who are not yet vaccinated than if used as boosters." That may be suggestive of the influence of global concerns. The attitude in America seems to be that those who want the inoculation(s) have received it, and yet many would like a booster. Among those who have not had the inoculation, there seems a range of ambivalence to defiance regarding getting it. I know people diametrically opposed to it. I have spoken with some simply unwilling to drive to town to get it. For whom are the doses being saved in a market that seems saturated with vaccine and absent of new customers? Is the described choice between "boosters" here and shipping it there a real choice?

These scientists seem troubled with the discussion of "boosting." They claim to have examined various research regarding the vaccines, and that "none of these studies has provided credible evidence of substantially declining protection against severe disease." Furthermore, they contend that discussion of "boosting" "could adversely affect confidence in vaccines and undermine messaging about the value of primary vaccination." I can almost hear Dr. Venkman now "you're scaring the straights" (Ghostbusters 2, Columbia 1989). The lesson here is that scientists need to be clear and concise when speaking to the rest of us; we lack your expertise and training, and will perhaps take as controlling your broad conclusions in the sound bites to which the news cycles and advertising have acclimated us. You can, it seems, damage your credibility. Yet, we need you and your credibility in a clear, careful, and expository fashion. 

The World Health Organization's argument is also tinged with sociology. The same CNN article quotes its leadership regarding the "right to be protected." The WHO Director-General believes that no "booster" program should be undertaken until the end of 2021. This, he contends, will allow more vaccine to be given to "low and lower-middle-income countries." The key word there may be "given" (you have eaten enough, you should fast until others have had a first helping). I defer the issues of socialism and egalitarianism for another day. He accuses both manufacturers and "countries that control the global supply," of relegating "the world's poor (to) . . . leftovers." The White House responded that this was "a false choice," and that vaccination can be delivered both domestically and abroad. In defense of the President, there is likely some truth to the contention that choices of global perspective are rarely simple dichotomies. 

And, there we have it. Conclusive, pervasive, and uncertain . . . doubt. Do I believe this scientist or that? Do I need a booster or do I not? If I do, then does that mean now? If I get a booster, am I denying life to someone elsewhere in the world? If I do not get a booster, am I putting myself, my family, and my local community at risk? Which is the more selfish, getting one for my community or deferring it in favor of some other community? Is there science to support one or the other, or merely a parade of consensus conclusions? And, why are those scientists leaving the FDA, is it the politics of disagreement and dissent or is it unworthy of our concern?

To echo the person quoted by the BBC, "Of course, I'm confused." Is that my fault? Bill, if you are reading this, IM me.  Thanks!