Tough Road for Vaccine

Terry Schwadron
5 min readOct 31, 2020

Terry H. Schwadron

Oct. 31, 2020

Bragging by Donald Trump aside, it now seems apparent that some kind of vaccines to counter coronavirus will emerge within the next weeks — or couple of months. That prospect, of course, raises a ton of new questions, from effectiveness to quantity, distribution and cost.

If possible, the White House put yet more pressure on a vaccine with televised remarks by Chief of Staff Mark Meadows that the feds cannot hope to control the pandemic, just the treatments. Of course, since Trump says that any media coverage of the pandemic before the election should be illegal, you and I are taking our chances in having this exchange altogether.

From oversimplification of the election chatter, Trump, will turn to the military and the states to distribute the vaccines any minute now, leaving unclear what he thinks his role will be if it all comes about starting before Jan. 21. Biden promises a stronger coordinating role for the federal government, which, of course, would not be difficult to produce since Trump has a hands-off approach.

With the actual electioneering out of the way, perhaps both could focus on the issues at hand. The rising number of cases — which sends Trump to his disagreeable Twitter account every time he hears a coronavirus headline — and an expectant country want answers, not more posturing.

As New York Gov. Andrew Cuomo has been saying in promoting his new coronavirus diaries, we’re about to sink beneath a new wave of government incompetence unless the election winner comes up with a recognizable plan for distributing vaccines rather than a helter-skelter approach among 50 states that either do or do not want to embrace vaccines.

But then, we have a continuing series of news developments about vaccines that are troubling:

— Trump, through Health and Human Services Secretary Alex Azar, wants to fire Dr. Stephen Hahn as head of the Federal Drug Administration for insisting on scientific review before approving any vaccine. Hey, what do we need with medical assurances that any of the differing approaches actually will work. We could always inject ourselves with bleach.

— Trump has quietly eliminated the office that evaluates vaccine effectiveness, another apparent pre-election political move to speed the vaccines. The function has left confusion among different agencies about who actually declares that one of these approaches work.

— The vaccines themselves do different things, from bolstering natural immunity to trying to identify and nullify the actual contagious elements through anti-bodies, and so on. Obviously, those clinical trials will test short-term reactions, but not long-term effects. We could end up being required to take a few different shots, all at taxpayer expense, unless time runs short and we turn it all over to insurance companies. Cue the anti-vaccine crowd.

— So far, there are pennies per person being devoted to vaccine distribution rather than several billion dollars. If Republicans don’t like spending on economic stimulus, they aren’t going to like spending on vaccine distribution either.

Is There a Plan?

There is money in the pending economic stimulus bill for vaccines, but it’s all a guess on how to provide hundreds of millions of doses of different kinds of medicines to Americans — to say nothing of offering the vaccine overseas to other nations.

For half of America or less to take the vaccine will mean that the whole multi-billion-dollar effort to force an early and miraculous answer to the pandemic may be for naught, since the contagion will continue among the un-vaccinated.

For most Americans, our politics have slid over the main linkage here between vaccinations and “normal” business openings. With a national vaccination program, we can open the economy more safely and more confidently. Trump has wanted to open now in anticipation of vaccines, without spelling out how distribution will work.

Instead, we’ve relied on government bromides about the elderly and first-line health workers getting the vaccine first, followed by . . . well, we don’t know that, do we? Again, Cuomo notes that it has taken us seven or eight months to test about 130 million people; how long will it take to inoculate 350 million Americans — potentially multiple times?

The planning and the money — estimates are more than $8 billion — are meant to pay big pharmaceutical companies for their development costs, and medical systems for running large-scale clinical trials. But what of the cost of hiring vaccinators, containers and the ultra-cold freezers needed to store doses of the Pfizer candidate, at least.

As a result of the Trump administration handling of coronavirus, we’ve lost a considerable amount of trust in the systems to provide even a normal sense of security. And it comes as we grapple with new breakouts of coronavirus with hospitals in the Midwest looking like New York last March.

Paul Mango, a senior official with Operation Warp Speed, the Trump administration’s effort to speed up COVID-19 vaccine development, told reporters last week that a vaccine would be “in people’s arms within 24–48 hours” of receiving emergency approval from the FDA. But the CDC’s Advisory Committee on Immunization Practices still plans to analyze data from the vaccine trials to determine how it should be distributed, and in what groups of people it is the most effective and safest.

And Cuomo, and other governors, are saying the feds have blown this so badly that they will want to run their own tests before distribution can begin,.

No First Steps

For the moment, there is no completed clinical trial, no determination that a single vaccine will work, and no money being sent to states to figure out how to get it out.

Meanwhile, we have absolutely no faith that Trump, who may not be president when the vaccine finally arrives, would work with Joe Biden to organize a non-political federal campaign to get a plan in place. Indeed, we have seen Trump m,oving against Dr. Hahn at the FDA, against Dr. Robert Redfield at the CDC and Dr. Anthony Fauci, the nation’s top immunologist. We’ve seen him abandoning advice from Dr. Deborah Birx, the Coronavirus Task Force lead medical advisory, for advice from his own choice, Dr. Scott Atlas, who is not an immunologist and who thinks herd immunity is a fine alternative to mask-wearing.

Pro-Publica just reported that Fauci is overseeing most of the ongoing vaccine trials in the U.S., but not that of the current front-runner made by Pfizer. Fauci is working with Moderna, Johnson & Johnson and AstraZeneca to decide whether the vaccines are ready to seek approval from FDA. .But he Fauci does not have the same hands-on role for the vaccine that seems poised to show results soonest — Pfizer, which opted not to accept government funding and participate in Operation Warp Speed. The government did make an almost $2 billion deal with Pfizer to preorder up to 600 million doses of the company’s vaccine, but it isn’t contributing money to the vaccine’s development like it is for other companies.

That brings us back to trust. Or lack of it.

It’s not a good sign for early resolution of vaccine issues.

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www,terryschwadron.wordpress.com

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