Covid Vaccines: We Were Doing Great. What Happened?

Courtesy Statista 2021

March 4, 2021, was my day of liberation. I got my second Covid vaccination that day. While it would still be two weeks for the inoculation to reach full effect, I could finally see the light at the end of the pandemic tunnel. At least for me.

Not for most of us, however. Weekly rates of vaccinations in the US peaked just before April 15 (Statista). They fell off at a faster pace after that week than they had climbed before the peak. What was going on?

At the beginning of April, there were three vaccines that had been released under “Emergency Use Authorization” (EUA) by the FDA. That means that the vaccine has passed safety tests, efficacy tests, and tests on thousands of recipients who represent the population it was developed to protect. Each of these phases requires rigorous data collection and analysis. It is a classic data-driven process meant to assure us that the vaccine is safe and effective. The advisors who recommend an EUA are independent of both the FDA and the companies developing the vaccines. They are selected based on expertise in the health sciences and in public health.

Boy, that sounds rigorous — because it is. And the above is only an abbreviated description of the process. There’s all sorts of reporting of “adverse events,” which are side effects attributed to the vaccine or vaccination process. Again, more data.

What happens when there are adverse events reported? Especially when they are more serious than a sore arm or a skin rash? Well, the Johnson & Johnson Company reported to the FDA that six women had suffered blood-clots that seemed to be linked to the vaccination. One died. Certainly worthy of a pause. The reports prompted the FDA to halt injectionsof the J&J vaccine on April 13.

Hmmm. That was exactly when the rate of vaccinations started to plummet.

Okay, but the blood clots were extremely rare — six cases out of seven million people vaccinated by the J&J injections in the US. Moreover, the other two vaccines by Moderna and Pfizer were still available. Finally, within ten days of the pause, FDA and CDC re-approved the J&J vaccinations for distribution. The reason? The benefits outweighed the risks with only a one in a million chance of an adverse reaction. (The lifetime likelihood of dying in a car crash is 1 in 107 or struck by lightning is 1 in 138,849.)

Why the sudden plunge in vaccinations?

Well, aside from the limitations of Americans’ knowledge of odds (which enriches every casino and fuels all state-run lotteries), survey data collected in late 2020 offers a bit of insight. The leading reason for avoiding the Covid vaccine was that Americans were “worried about possible side effects” — 59%. (Statista) That was a big concern by people who would either hesitate or even oppose vaccinations for Covid.

So, even without believing that Bill Gates is putting microchips in the vaccine vials or that the injections would make people magnetic, many people were primed for bad news about vaccine side effects. The news that J&J’s vaccine posed a minuscule risk clearly triggered both personal and media reactions.

Was everyone suddenly afraid of the vaccine? A closer look by a public health official, Dr. Nirav Shah (director of the Maine CDC and the president of the ASTHO) classifies the hesitant into three groups: “not able,” “not now” and “not ever.” The first run into the usual issues of modern life — getting time off work, arranging child care, etc. The second are classic questioners of vaccine safety and efficacy — not opposed — just skeptical. The third are never-vaxers who probably cannot be won over by evidence. (See US scientific illiteracy and innumeracy, above.)

Apparently, two of these three groups were primed to see the blood clots as triggers to opposition, enough of them to cause the drop in weekly averages for vaccinations peek at 3.5 million in April to less than half a million in July. The third got their bias confirmed, bigly.

Now we are awash in unwanted vaccine doses that have been proven by real-world experience to be safe and effective — outweighing any risks involved. Many in the opposition camp have shifted to the argument that the FDA has not issued full “approval” the vaccines, meaning that it issues a Biologics License to the manufacturer.

It might not help if the FDA issues a full approval, but it can’t hurt. The weight of evidence that vaccines are safe and effective continues to mount, crushing any thoughtful hesitation or even opposition. (Not that that really budges the stubborn.)

But it does beg one more question: What is the FDA waiting for?

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David Potenziani

Historian, informatician, novelist, and grandfather. Part-time curmugdeon.