What if the COVID vaccine had been launched sooner?

Bias alert: I’m pro-vax and plan to get vaccinated as soon as I can.
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On one hand, Trump has been justifiably basking in the success of his Operation Warp Speed program that encouraged and enabled pharma to speed up the development process.

It has been a sheer delight seeing the video loops of media pundits and “experts” looking ridiculous when previously dismissing the possibility of a vaccine by now.

See It’s official: Fauci whiffs, again!

Even Sen. Dickie Durbin — to his credit — stepped to the podium on the Senate floor to give Trump a shout-out for a job well done.

And yesterday, Biden conceded that “the Trump administration deserves some of the credit”.

But, headlines the past couple of days seem to be highlighting the logistical challenges, priority controversies and possible negative consequences of the COVID vaccines: “Man in Alaska Suffers Serious Side Effects”, “40% of Chicago Medical Staff Refuses the Vaccine”, etc.

So, I realize that I may be swimming upstream today, channeling a very provocative point-of-view that I saw offered up by Holman Jenkins in the WSJ:

Science triumphed but shouldn’t we have cut corners and moved faster?

Let’s drill down that…

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Specifically, lets connect a couple of dots….

40% of COVID deaths in nursing homes

According to the COVID Tracking Project and the Kaiser Family Foundation (KFF):

  • Less than 1% of America’s population lives in long-term care (LTC) facilities
  • But, this tiny fraction of the country  has accounted for over 100,000 COVID-19 deaths … almost 40% of the US total.

image

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Vaccine designs were developed in January

Jenkins reports that:

The design for Moderna’s vaccine was completed on Jan. 13, two days after the Chinese released the genetic makeup of the new virus.

Pfizer whittled 20 slightly different designs down to two between January and July.

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3-Phase Trials Dragged the Process Out

Here’s where things get a bit dicey…

Paraphrasing, Jenkins also opines that Pfizer and Modena could have developed faster and launched sooner if not for the drawn-out, three-phase clinical trials that were required.

What? Short circuit the Gold Standard of pharmaceutical testing?

That’s blasphemy!

Public talk from the start focused on the risk to public confidence of any shortcuts, any deviation from standard development protocols.

Federal agencies and politicians had a natural incentive to minimize any blowback on themselves from departing from accepted models of drug development.

But it’s not obvious this was optimal under conditions of the pandemic.

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Remember Right-to-Try?

Look back at the Kaiser chart…

Despite locking down the facilities, LTC deaths continued to accumulate during the year … about half of the LTC deaths have occurred in the 2nd half of the year. 

Jenkins reminds that China and Russia early-launched large voluntary distributions of relatively less-tested vaccines … which sets-up the question:

What if we had launched widespread, high volume clinical trials in July, in LTC facilities across the country?

Completely voluntary (i.e. Right-to-Try) … signed off by responsible patients or their “living will” designates.

Of course, the “trial” would include a full spell-out of the benefits (countering the the LTC-localized COVID death rampage) … and the risks (unknown effectiveness, possible side effects).

My bet, there would have been a big take-up …despite the likely scientists’ hand-wringing and media uproar.

Retrospectively, such “wreckless” and  “premature” action might have saved the better part of 50,000 lives.

Hmmm.

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In conclusion

Jenkins concludes:

In the trade-off between speed and safety, silver and bronze approaches were always possible to get a vaccine into the market faster albeit with somewhat higher risk.

Our near-standard approach ended up being successful beyond early hopes, no question.

But a clinical lookback won’t automatically conclude (the standard 3-phase protocol) was the best approach under the circumstances.

I like the way this guy thinks…

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For the record: My family has personal experience with difficult LTC medical decisions, clinical trials and the Right-to-Try “experimental” drugs and treatments.

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