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Tuesday, February 2, 2021

The Future's so Bright

In 1985 Timbuk 3 released "The Future's So Bright." The song's perspective is of a student who "study(ies) nuclear science" and who "love(s) his classes." He explains that he has "a crazy teacher" who "wears dark glasses." And, he concludes, "The future's so bright, I gotta wear shades." I can feel that. Our future is certainly looking bright. 

There is an assortment of impacts to this world from COVID-19. We have seen impacts on micro and macro levels, ranging from our own personal convenience to those of our communities. Unfortunately, the virus that causes the disease, SARS-CoV-2 is difficult to avoid and apparently fairly simple to transmit. We are somewhat fortunate that the scientists rapidly learned how to test for it, and less than a year after it arrived here at least four notable vaccines are already approved and being administered. Bloomberg reports that the Russian vaccine is as promising, and is set for wide distribution, as are other names like "GlaxoSmithKline Plc and Sanofi." Statistica concludes that 12 vaccines have been launched" and that 78 more are in "phase three clinical" trials. 

That, in itself, is amazing. The leading American scientist regarding COVID-19, opined less than a year ago that a vaccine for this malady could not be produced in less than a year. On April 1, 2020, CNN reported "The timetable for a coronavirus vaccine is 18 months. Experts say that's risky." There, it quoted "the head of the National Institute of Allergy and Infectious Diseases (NIAID)," explaining that "it would be . . . a year to a year and a half." Other experts were quoted there with their own pessimism and doubts. One noted, "I think that's optimistic." That is, 365 days to 550 days is "optimistic." That is, "a" vaccine that rapidly is "optimistic."

Dinah Washington won a Grammy in 1959 for her rendition of "What a Difference a Day Makes." Perhaps it is time for someone to re-record that classic but change it to a few months. On December 14, 2020, The Washington Post reported that the first (other than trials and tests) COVID-19 vaccine injections had occurred in the United States. That is 257 days after the CNN report that 550 days would be "optimistic."

On December 11, 2020, the Pfizer vaccine received FDA Emergency Use Approval.

On December 18, 2020, the Moderna vaccine received FDA Emergency Use Approval.

On December 30, 2020, the Astrazeneca (Oxford) vaccine was approved for emergency us in the United Kingdom.

On January 15, 2021, The Astrazenca and Bharat Biotech vaccines were approved for use in India.

The first week of February 2021, Johnson and Johnson will apply for Emergency Use Approval from the FDA.

The New York Times has a vaccine tracker that provides overviews of various efforts and progress. 

Is it a failure of science that predictions were so wrong? There are various opportunities to doubt science. But science is the practice and process of forming hypotheses, putting them to rigorous testing and challenge, gathering facts and data regarding that testing, and determining whether a particular hypothesis does or does not hold. The predictions of the experts on April 1, 2020, were not science in this regard. 

People who practice science are called scientists. From their work, training, and experience, they form opinions ("a belief or judgment that rests on grounds insufficient to produce complete certainty"). Opinions are conclusions or beliefs. They may be based upon, referenced from, science. But, they are not themselves necessarily science (reproducible results in the form of data to support a hypothesis).

Opinions can be accurate, or not. They are undoubtedly often the conclusions of intelligent people. They are often conclusions that are influenced by experience, intelligence, or even science. They are sometimes wrong. Today, there are at least four (Pfizer, Moderna, Astrazeneca, Bharat Biotech) vaccines, not "a" vaccine, that has beaten the best, educated, guesses (opinions) of the experts. It is entirely likely that more will beat that "optimistic" 365 to 550 days professed by the "experts" last April. The experts were wrong. The first vaccine was injected (other than earlier clinical trials) 257 days after "they" said it would take 12 to 18 months.

I for one am glad they were wrong. I hear complaints about the current vaccine distribution process. There is criticism and dissatisfaction voiced. But, according to National Public Radio, "more than 27 million doses have been administered" as of January 30, 2021. That is "6.9% of the total U.S. population," and the most recent volume is about "1.3 million shots a day" in the United States. Other news outlets claim higher numbers. We are 45 days into the process, and despite the complaints, millions have been inoculated.

That is about 45 days (December 14, 2020), to achieve injection of 6.9% of the population. And, it may be noteworthy that 45 days included two major holidays and their impacts on lives and livelihoods. Certainly, the injection volume ("27 million doses") may include both the first and second injections. Let's all remember that both Pfizer and Moderna require two injections per person. The 328.2 million Americans, at 1.3 million per day, will require about 252 days to inoculate (if only with that first injection). And, it is possible that Johnson & Johnson and others will increase that pace with the addition of more alternatives and more production.

Undoubtedly, Johnson & Johnson is the news as February dawns. It is important to note, however, that "As of January 29, 2021, there were 1,043 drugs and vaccines in development," as reported by Statista. There are at least four being injected, one applying for FDA Emergency Use, and many more reportedly in the process. The future is indeed looking promising.

What if the "new" hopes do not arrive. Consider that if 252 days to inject the entire population using the current two (in the U.S. only Pfizer and Moderna) is added to the 257 the scientists needed to develop, test, and deploy, the total is 509 days. Add in the 45 days since December 14, 2020, and you are at 554 days. Notably the time frame, to potential completion of deployment in the U.S., is just over the 550-day "optimistic" period for the development of "a" vaccine opined by "the head of the National Institute of Allergy and Infectious Diseases" last April.

I have detailed the math for these conclusions. It is based upon assumptions (that the 1.3 million daily is sustainable from supply and logistic perspectives, etc.). It is based upon facts known and suppositions drawn. And, it might ultimately be right or wrong. It is an opinion in the form of a projection. If it is wrong, the reader may look back in another 252 days (10/11/21) and correct this math. The reader then will have the numbers known for tomorrow, which I must project and predict today. In hindsight, there will be clarity and certainty. Provided the data then, I might well explain where my assumptions, suppositions, and predictions went awry. I hope the reader will hold me to making such an explanation if I turn out to be wrong. 

Similarly, opinions were rendered on the vaccine development, by the experts, and they were wrong. The degree or extent of their error in judgment is open to discussion. But, they were wrong. There is surprisingly little discussion in the current news about their predictions for April 1, 2020. One November 2020 report from WRAL TechWire humorously reminded us of a Yogi Berra quote in this regard: "it’s tough to make predictions, especially about the future." That is absolutely true, predictions are tough. 

Certainly, people are wrong every day. But, where is the news coverage regarding how notably wrong the leading experts were in this instance? Where is the discussion of what facts were relied upon in rendering those April 1, 2020 opinions? Where is the analysis of how the science itself outpaced the doubters and delivered these vaccines to our local health departments and retailers beginning a mere 9 months after the experts said a year to eighteen months was "optimistic?" Where is the reassurance that we can nonetheless rely upon these experts as they continue to render opinions? 

Can we depend upon the late January opinion of "the (same) head of the National Institute of Allergy and Infectious Diseases" that "things will get worse?" Would, or could, our path to faith in these opinions be eased if someone explained how the experts so miscalculated, or misstated, or mistook their 12 to 18 month "optimistic" opinions last April Fools Day? 

In all, from my perspective Timbuk 3's lyrics apply to February 2021: as to vaccination, "things are going great, and they're only getting better."

Now, we look toward other concerns. Are there potentials for liability related to the injection of a vaccine? Some news articles have memorialized the legal opinions of doctors on these potentials. Some media have reported their legal opinions, without questioning their expertise in the law. 

Liability can be complex. There are potential liability questions as to manufacturer or dispensing parties. However, the release required to obtain these vaccines are broad. The Moderna release form includes:
"I understand that this product has not been approved or licensed by FDA."

"I understand that it is not possible to predict all possible side effects or complications."

"I hereby release and hold harmless the State of Florida, the Florida Department of Health (DOH), and their staff, agents, successors . . .."

The Pfizer form is similar. Will there be side-effects or complications? Will liability follow? Some prognosticate that in the world of workers' compensation there may be issues of employer liability. To some extent this may be notably dependent upon whether an employee was required to undergo the vaccination. The broad issues and implications will be the subject of a HotSeat webinar on February 11, 2021. That program will include medical and legal leaders with opinions and thoughts regarding this inoculation effort. 

There is room for misgivings and uncertainty. Undoubtedly, this pandemic has included many predictions and challenges. Uncertainty has perhaps been one of its more persistent features. But, the vaccines are being injected at a fantastic pace and the logistics seem to be improving. From where I sit, the "Future's so Bright." Hand me my shades Timbuk 3. And, join us February 11 for the HotSeat as we discuss the ongoing inoculation effort and whether it is "Risky Business."