On the menu today: Whether our goal is persuading the unvaccinated to get their shots, or protecting kids as school begins, or ensuring that the elderly do not have declining immunity against COVID-19, the public-health bureaucracies in the FDA and CDC are proving to be a persistently frustrating obstacle.
The FDA and CDC Run at the Speed of a Federal Bureaucracy
The heart of our problem is that the threat we face moves at the speed of a highly contagious virus, and the solution moves at the speed of bureaucracy.
Is our primary goal to persuade the unvaccinated to get vaccinated? Then we need to get the FDA to issue final approval, not just an emergency-use authorization, for the available vaccines. It’s not the only solution, but it’s a key part of a solution.
The New York Times estimates, based upon survey data, that 10 percent of U.S. adults describe themselves as unvaccinated but potentially persuadable to get the vaccine, which the Times calls the “wait and see” group. That’s about 21 million people.
In a Kaiser survey in June, nearly half of the “wait and see” group (44 percent) said they would be “more likely” to get a vaccine if one of the vaccines currently authorized for emergency use received full approval from the FDA.
That’s about 9.2 million American adults. It is likely that at least some of those adults are exaggerating how important full approval is in their decision-making. But not all of them are.
The argument from most vaccination advocates is that for the average person trying to avoid COVID-19, there’s no real difference between the FDA granting an emergency-use authorization, and the FDA approving a biological license application. In both cases, the FDA is declaring to the public that, “This vaccine is safe, and you should take it to protect yourself from the virus.”
But if we ask, “If there’s no real difference, why can’t the FDA just grant final approval?” we’re told that the FDA hasn’t finished looking at the data yet. Clearly, there is a difference. There’s something absurd about the FDA saying it doesn’t have enough data about how these vaccines affect people to make a final decision, when 191 million Americans have received at least one shot. The data are all around us!
Both Pfizer and Moderna submitted their biological license applications back in early May. Johnson & Johnson submitted their application about a month later. In the middle of July, Pfizer announced that the FDA had informed them that the agency had granted “priority review” for their Biologics License Application, which means that the goal date for a decision by the FDA was . . . January 2022. On Friday, the FDA announced that it had “rolled out an all hands on deck” approach to expediting final approval. It seems fair to wonder just what the agency was doing before the “all hands on deck” approach.
Among other consequences, the U.S. military cannot require personnel to get a vaccine that does not have full approval from the FDA. Right now, about 885,000 U.S. military personnel are fully vaccinated, and about 480,000 aren’t. And company mandates requiring employees to get vaccinated against COVID-19 will be on much more solid ground against legal challenges with a vaccine fully authorized by the FDA, instead of one that is authorized for emergency use.
Again, when the FDA gives that final approval, about 9 million people said that factor would get them off the fence. Maybe they’re lying, and just using the lack of full approval as an excuse. But there is something contradictory about telling people “Trust the science!” and then quietly acknowledging that “the science” hasn’t given its full, final, no-ifs, ands, or buts approval to the vaccine.
Is our primary goal to protect children from COVID-19?
Then we need kid-friendly versions of the vaccines available as soon as possible — and the FDA’s current estimate of “midwinter” availability isn’t good enough.
Because of the different timelines for FDA approval, some people may believe that the kid version, the teen version, and the adult version of the vaccines are all different formulas. In fact, they’re all the same! The adult and teen vaccines are even the same-sized doses, although the clinical trials of the children’s vaccines are testing doses of varying size.
Moderna and Pfizer started recruiting kids for vaccine trials in March. But the FDA wants four to six months of safety follow-up data for kids under age twelve.
One of the more frustrating moments of Biden’s press conference last week was his tone-deaf plea: “Parents, get your children vaccinated. You do it for so many other things right now.” Parents of kids under twelve don’t have that option — at least, not without lying about their child’s age. There’s something bizarre about seeing calls for vaccine mandates for all students in all schools, including elementary schools, when everybody in sixth grade and below can’t get it yet, and reportedly may not get it before 2022.
Is our primary goal to ensure that our elderly citizens don’t have waning immune-system resistance against COVID-19 variants? Then let’s authorize boosters.
If I had to guess the next headache in the Biden administration’s messaging on the pandemic, it will be this statement from President Biden on Thursday: “I also know many of you are wondering if you’ll need a booster shot to add another layer of protection. As of now, my medical advisors say the answer is no. No American needs a booster now. But if the science tells us there’s a need for boosters, then that’s something we’ll do.”
Israel is giving citizens over age 60 booster shots. They’re doing this after a study determined that the two-shot Pfizer vaccination, after six months, is still 91 percent effective at preventing hospitalization . . . but only 39 percent effective at preventing infection and transmission. That’s not the worst possible news, but it’s ominous. The elderly generally have weaker immune systems and are just more vulnerable to infections of all kinds — more infections among this demographic will almost inevitably result in more hospitalizations and deaths, even if those dire outcomes are much rarer than they would be among the unvaccinated elderly.
Quite a few Americans who received their shots in December and January have passed or are coming up on that six-month anniversary. In fact, Joe Biden received his second shot of the Pfizer vaccine January 11, which means he was fully vaccinated January 25. Six months after January 25 was . . . a week ago, Sunday.
Right now, an American senior citizen cannot get a third shot. (I’ve heard from some people that if you go to a different spot than where you got your first shots, they may not check against any available records in the Vaccine Administration Management System. I’ve also heard that some places are being less than strict about the twelve-or-older age requirement.) Our current policy is to offer $100 to people who don’t want to get vaccinated and to deny a third shot to those who want one. This is an inflexible, bureaucratic mindset at work.
The first U.S. vaccine trials began 75 days after the first reports of a pneumonia in Wuhan; the first shot went into the first arm on March 16, 2020. We can develop potential vaccines with remarkable speed.
Speaking of Vaccine Reluctance . . .
This article from the comedy magazine Cracked makes the good point that if you find American society in 2021 to be an infuriatingly scientifically illiterate land of gullible goobers falling for every snake-oil sales pitch that comes down the pike, the problem was cultivated by some particularly beloved celebrities.
If you want to blame Donald Trump, Joe Rogan, Alex Jones, or Alex Berenson for COVID-vaccine skepticism or anti-vaxxers, go ahead. But keep in mind that the current COVID-vaccine opposition was built upon preexisting anti-vaccine beliefs, which were heavily fueled by Jenny McCarthy, Jim Carrey, and other anti-vaccine activists who were given a welcome platform by Oprah Winfrey. (And this isn’t even getting into Robert Kennedy Jr.)
Oprah herself appears to have no issues with vaccines, but she’s done as much as anyone to peddle the myth that the science is somehow still up for debate, that COVID and smallpox can be batted away with the power of good vibes… Medical science isn’t perfect. Doctors can make mistakes, rare adverse reactions can happen. There’s no conspiracy there; that, unfortunately, is just life. But on Oprah, individual stories of people heroically standing up against some supposed nefarious system made for good ratings, and now we’re all paying for it.
ADDENDUM: A lot of people seemed to relish the argument that former president Barack Obama was being reckless by hosting a 60th birthday party on Martha’s Vineyard, with 475 guests and 200 staff. But this is something akin to Lollapalooza in Chicago this past week — if everyone or almost everyone is vaccinated, and anyone who isn’t vaccinated has recently tested negative, you’ve made the event about as safe as you can make it. Vaccinated people are not a risk to other vaccinated people. Unvaccinated people are not a risk to vaccinated people! The people who are really at risk are the unvaccinated — and they’ve accepted the risks and potential consequences of their decisions.