June 9th 2020

By Dartagnan (from the Daily Kos community)

Daily Kos

If anyone else were president, this type of suggestion would sound like some CT out of left field. Unfortunately, we have a deranged sociopath in the Oval Office, one who has already proven his utter disregard for American lives, and one who is literally facing potential jail time if he fails to get re-elected, so quite honestly, all bets are off, including the following scenario:

Oct. 23, 2020, 9 a.m., with 10 days before the election, Fox News releases a poll showing President Trump trailing Joe Biden by eight percentage points.

Oct. 23, 2020, 3 p.m., at a hastily convened news conference, President Trump announces that the Food and Drug Administration has just issued an Emergency Use Authorization for a coronavirus vaccine. Mr. Trump declares victory over Covid-19, demands that all businesses reopen immediately and predicts a rapid economic recovery.

Drs. Ezekial J. Emanuel, an oncologist and bioethicist, and Paul A. Offit, a pediatrician who specializes in immunology and infectious diseases, are the authors of an alarming Op-ed, published in Monday’s New York Times , titled “Could Trump Turn a Vaccine Into a Campaign Stunt?”   Dr. Offit is also the co-inventor of a rotavirus vaccine. Both are professors at the University of Pennsylvania. And both are worried right now.

Emanuel and Offit believe that based on Trump’s prior record of contempt for medical science and given his penchant for exaggerating the benefits of unproven cures to stoke his own political prospects, the scenario described above is well within the realm of possibility. Specifically, they believe that “In a desperate search for a political boost, [Trump] could release a coronavirus vaccine before it had been thoroughly tested and shown to be safe and effective.”

The authors note that the National Institutes of Health will be conducting trials on at least 10 different potential vaccines during the summer with Astra Zeneca and Pfizer poised to conduct larger-scale administration of their sample vaccines into October. However, that is just the end of the beginning, so to speak, to determine whether such vaccines are actually safe across the population.

Researchers are expecting that it will be likely to take at least another eight to 12 months to determine whether these coronavirus vaccines are effective. Scientists have to wait until a sufficient number of patients are exposed to coronavirus to see if the vaccine really reduces the infection rate, as well as how many people develop uncommon side effects.

The authors allow that one possible (but highly unlikely) scenario that would expedite the process is would be an unusually rapid recruitment of a huge volunteer group in a COVID-19 “hot spot,” which could theoretically provide enough data to determine a vaccine’s reliability and safety. But they consider another possibility, one which would appear to provide an irresistible temptation to someone like Donald Trump.

There is another scenario that is far more ominous: Three months after the N.I.H. trials begin in July — so, mid October — studies reveal many patients are developing high levels of antibodies to the coronavirus without severe side effects. As the White House did with its relentless promotion of hydroxychloroquine as a cure, it would badger the F.D.A. to permit use of the vaccine. More pressure would come from drug companies, some of whom may spend up to $1 billion on research and are intensely competing for prestige and glory. They are planning to begin manufacturing their vaccine candidates at-risk — that is, before completed studies showing their vaccine is actually effective.

The authors suggest that Trump has laid the potential groundwork for applying such political pressure to the FDA, and they cite the demotion of Rick Bright after the latter resisted Trump’s efforts to promote hydroxychloroquine as a “miracle cure” for the novel coronavirus. Under intense pressure from administration officials faced with poll numbers in October as poor or worse than what Trump is facing now, the FDA could issue an “Emergency Use Authorization”  which requires a much lower standard of reliability for the dissemination of any vaccine. According to the authors, such an “Emergency Use Authorization” would “only require that the FDA  finds it ‘reasonable to believe’ that a vaccine ‘may be effective’ in preventing a life-threatening disease for it to be put on the market, without being formally licensed.

As the authors point out, this would provide Trump with an opportunity to declare “victory” over the COVID-19 pandemic, a declaration that would almost certainly be looked favorably on by Wall Street and the financial markets. They theorize that Trump could easily dovetail such a declaration with emphasis on an imminent economic recovery as a consequence. Millions of Americans would thereby be permitted to receive a vaccine that was untested and essentially unproven by the rigorous, “large, prospective, placebo-controlled studies of safety and effectiveness,” that have preceded the distribution and licensing of every vaccine produced in this country (such as the polio vaccine) over the past 70 years.

The current trials scheduled to occur pre-October involve, at the most, 20,000 patients receiving the actual vaccine (as opposed to the research control). According to Emanuel and Offit, that is not nearly enough to determine whether a vaccine is safe for use in the general population, even if antibodies are produced. As they note, the presence of antibodies in a trial vaccine does not equate with prevention of infection, much less the prevention of infection among a more susceptible, elderly population.  But human nature being what it is, a false sense of being protected among those so “immunized” would almost certainly lead to higher risk behavior and further potential outbreaks.

Donald Trump and the sycophants within his administration have amply demonstrated their ineptitude and complete indifference towards Americans’ health and lives in their gross mishandling of the Covid-19 pandemic. We already know there is no bottom, no limit to which Trump will not stoop when he finds himself threatened. Sadly, sacrificing American citizens to the altar of his re-election prospects isn’t remotely beyond his capacity for malevolence.

Posted with permission