It was about 8:45 Monday morning when an alert from The Washington Post came across my email: “FDA grants full approval to Pfizer-BioNTech coronavirus vaccine, potentially persuading the hesitant to get the shots.”
Finally, I thought. Finally we’ll see who was using the emergency use authorization (EUA) as a flimsy excuse. Those will be the people shifting goalposts this week.
In a statement, FDA acting commissioner Janet Woodcock said: “The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved covid-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product. While millions of people have already safely received covid-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
For some, we know that won’t be enough. If the surge of the more infectious and deadly Delta variant hasn’t been enough to convince anti-vaxxers, full FDA approval/licensure won’t instantly make them think, “Hey, I really should get vaccinated so that, even if I do get infected, I most likely won’t end up on a ventilator or die.”
Those rare breakthrough cases (still less than 1 percent of the total cases, and most appear to be due to the Delta variant) are enough to make them dig in even further. Why, they’ll just take their chances because the odds of survival are great.
Sure, tell that to the 628,000-plus people who’ve died in the United States from covid-19, out of 4.4 million-plus worldwide. (U.S. deaths are 14 percent of the total deaths, and 18 percent of total cases, according to Johns Hopkins’ numbers.)
But numbers mean nothing to those who are vociferously opposed to getting vaccinated. As the editorial in the Arkansas Democrat-Gazette said Tuesday: “But that’s reasoning. And it’s been said before: You can’t reason somebody out of an opinion if he hasn’t been reasoned into it. And for some reason the covid-19 vaccine has had opposition that the flu shot never had.”
I’d blame the bulk of the opposition on the politicization of the pandemic (echoed by polls of partisans who refuse to vaccinate; Philip Bump of The Washington Post sees what’s happened in the pandemic as partially a result of the base leading the party). When you have a very vocal minority wanting to “own the libs” (and I guess those of us without political affiliation who believe in listening to actual experts), spreading misinformation and castigating those who’ve followed pandemic protocols as “living in fear” … well, you get what’s happening in the U.S. now, especially in the South.
Which is how you end up with so many people who’ve done the right things angry with those who refuse. As Paul Krugman wrote last week: “To say what should be obvious, getting vaccinated and wearing a mask in public spaces aren’t ‘personal choices.’ When you reject your shots or refuse to mask up, you’re increasing my risk of catching a potentially deadly or disabling disease and also helping to perpetuate the social and economic costs of the pandemic. In a very real sense, the irresponsible minority is depriving the rest of us of life, liberty and the pursuit of happiness.”
Now that Pfizer has full approval, the goalposts are being moved. For those not steeped in the language of debate, logic and persuasive writing, don’t worry; I’m not getting ready to suit up for a game … unless that game is on my iPad.
“Moving the goalposts,” according to Logically Fallacious, means “demanding from an opponent that he or she address more and more points after the initial counter-argument has been satisfied, refusing to concede or accept the opponent’s argument.” Those who’ve dealt with trolls on comment boards are very familiar with this tactic. (They also love to insult whoever doesn’t agree with them, make up things they say those people have said, post things that have nothing to do with the discussion, etc. … can you tell I don’t like trolls or their tactics?)
We can expect that a good portion of those who have refused to vaccinate on the basis that the vaccine hadn’t been given full approval will likely move to the argument that the decision to grant full approval was rushed. I mean, heck, goalposts have been moved multiple times by the data as more information became available, but by itself, the Delta variant moved the goalposts by being so contagious that ending the pandemic with a vaccine became even more important.
So, yeah, the approval was a bit speedy, partly because of the number of people who refused a vaccine with only an EUA despite the fact that we’re in the middle of a public-health emergency. As Ben Guarino, Laurie McGinley and Tyler Pager of The Washington Post reported, it was the fastest vaccine approval in the history of the FDA. Critics had demanded the FDA move quickly, they wrote, saying the shots’ effectiveness and safety had been amply demonstrated by the millions of vaccinations administered since authorization.
Still, the FDA didn’t want to give the impression of a rush job, so it dedicated more staff and resources (and lots of overtime) while still insisting on six months’ follow-up data on those enrolled in the clinical trial. So while it was quick (about four months after Pfizer applied for licensing), it was based on much more data than the original EUA. And even though it’s got full approval, FDA oversight will continue, as it does for all pharmaceuticals.
But yeah, I know, government bad.
No matter what, unless you have a valid medical or religious reason not to be vaccinated, you should take personal responsibility and get the shots as soon as you can so that we can find our way out of this mess. I have my “plague pass,” as do many others, but more need to roll up their sleeves, whether they’re Medicaid recipients unaware the shots are free, or people who think they’re invulnerable.
Why? Because when it comes to an infectious disease that has killed or disabled millions, your actions or lack thereof affects others unless you’re completely isolated.
There will be other goalposts moved in the meantime.
For those people who think there is not enough research: If 18 months’ worth of data during a public-health emergency isn’t enough, it will be two, or three, or five years they’ll want. In that case, if the variants keep getting deadlier, well, they might not be around long enough for “enough” data. Which also takes care of those who say, “I’ll wait for herd immunity.”
Because of the full approval, the FDA will no longer require the word “experimental” on literature handed out with the Pfizer vaccination, which will, hopefully, lead to more vaccinations. University of Maryland School of Public Health professor Sandra C. Quinn, who has studied public acceptance of vaccines under emergency authorization since the H1N1 influenza outbreak in 2009, told The Washington Post: “A full approval takes away that ‘Oh, it’s experimental’ kind of language. For some people, it might make a difference. They will feel more confident and comfortable.” But how much do you want to bet the anti-vaxxers, because the approval is so new, will still decide it’s “experimental” and thus not safe to introduce into their bodies (but veterinary drugs meant for livestock to treat parasites, which the virus is not, are perfectly fine, which is why health departments have to put out notices and pleas not to take such things)?
They’re still trotting out the saw about long-term negative effects of the vaccine, which of course means they would need maybe 10 or 20 years’ worth of data to ensure that there’s no danger. Except … the actual vaccine is in your body for a relatively short period of time, especially if it’s an mRNA version. It’s the vaccine-triggered immune response and antibodies to the disease that protect you. Scientists say that any side effects will show up in the first month after vaccination. The side effects of the disease, on the other hand, can cause long-term problems.
No matter what issue is resolved, these people will always find another reason not to face the needle.
Someone please make sure they stretch first. Moving those goalposts can be strenuous.