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If you’re reading this, you’re probably a relatively well-read person. You probably believe that the COVID-19 vaccines work. Hey, it turns out that’s a bar that a lot of people can’t jump over, so good for you!
But just because you’ve cleared that hurdle doesn’t mean you don’t have questions about the vaccine. I get questions like this in my inbox every day, questions about vaccines for kids, or full approval of the vaccine, or what impact the shot has on the previously infected. I also get questions from people curious if they’ll need an additional dose — some who got the Johnson & Johnson one-dose vaccine, and some who might worry that their vaccines’ protection might degrade over time.
Well, the good news is that we’re starting to answer those questions in a more satisfying way — though, I concede, not always completely satisfying. Consider this an update on the frequently asked questions about the vaccine.
What’s the deal with vaccines for kids?
Back in March, I wrote about how the vaccine for kids looked likely to come at the end of 2021 or the beginning of 2022. That’s still our likely time frame, but it seems like any hope of expediting the process has been extinguished by a recent federal move.
At the end of July, the Food and Drug Administration asked Pfizer to expand its trials on kids to ensure that the vaccine didn’t lead to heart issues in children. Originally, the trials had about 7,000 kids. The FDA wanted more. To some degree, that move makes sense: If the vaccine were causing long-term heart issues in children at a rate of even one in 10,000, we’d want to know about it before inoculating millions of kids.
And yet, it’s a frustrating outcome. If the FDA wanted more tests on kids, it would have been nice to tell Pfizer when the trial was originally being designed, not now. Doing so now delays results over the alternative, because we have to have time to vaccinate the new trial children twice, then watch for at least two months (or perhaps six months; this also is a matter of some debate) to see if they get side effects.
The American Academy of Pediatrics has complained about this, essentially saying, “Hey, we understand what you’re going for here, but let’s not forget about the downsides of delaying this vaccine. We already have data from the previously enrolled kids, let’s just use that.” On the other side, we all know what would happen if even a small number of kids see serious side effects: even further distrust of vaccines for decades.
It’s not an enviable decision. I agree mostly with the AAP, but pretending this is an obvious call in either direction is an oversimplification. Still, don’t expect movement on this soon.
Full FDA approval for the vaccine
While we’re here, let’s talk about FDA approval of the vaccine for everyone else.
As you probably already know — hey, your smarts are a consistent theme here — the vaccines are currently being given under an emergency use authorization, which basically is a quicker-but-still-pretty-robust approval pathway the FDA created for drug use in emergencies like a global pandemic.
The emergency go-ahead isn’t quite the full approval process, though, which usually takes a few years. Honestly, with a standard drug, most of that time is typically paper pushing and data analysis, which has already been done with the COVID-19 vaccines, thanks to the crushing crisis at hand. Even more useful to approval, the vaccine has also been given to hundreds of millions of people, so we have a really good idea of the consequences of giving it to tens of millions more. The bad consequences are rare, while the good consequences are real.
So that gives people like Dr. Anthony Fauci hope that approval will come this month. Pfizer’s vaccine will probably gain full approval first.
Will that result in more people taking the vaccine? I’m of the opinion that, if you’re an individual who says you’ve been waiting for full FDA approval, that’s probably more indicative of other fears or roadblocks — there’s just too much actual evidence already that the vaccine works and is safe.
But full FDA approval might be effective as a political move, giving our leaders more basis to make some common-sense moves to encourage vaccination. That could be in the form of incentives, or it could be in the form of rules to prevent the unvaccinated from taking part in certain high-risk activities. We’ll see.
Vaccines for the previously infected
What about vaccines for those who have previously been infected? There has been solid evidence that nearly everyone who gets infected with the coronavirus develops antibodies and some level of protection to the disease, but does getting vaccinated on top of that help?
It does. The health department in Kentucky looked at their residents who faced reinfection and found 2.34 times more reinfections in the unvaccinated group than in the fully vaccinated group.
That makes sense. We know that the previously infected plus vaccination combo has higher levels of antibodies than any other group. In short, giving your immune system that many exposures to the coronavirus spike signature gives it the tools it needs to fend off infection extremely well.
Good news on the Johnson & Johnson front
I’ve been worried about my Johnson & Johnson vaccine friends recently, but a recent study from South Africa has made me feel somewhat better.
The Sisonke trial of health care workers in South Africa — enrolling nearly 500,000 participants, a remarkable number — discovered that one dose of the Johnson & Johnson vaccine was about 95% effective against death and 71% effective against hospitalization against the delta variant when compared with those who were not vaccinated. When breakthrough infections did occur, the symptoms were mild in 96% of the cases.
To be sure, those numbers are still worse than the mRNA vaccines like Pfizer and Moderna, which afford protection of about 96% against hospitalization against delta. But they’re about the same difference as we saw against the variants spreading last winter. In short: If you got the one-dose Johnson & Johnson vaccine, you already probably knew about the lower efficacy when compared with the two-dose vaccines. The same maxim still applies today: Johnson & Johnson is effective, but less so.
Is 95% protection against death and 71% protection against hospitalization good enough for you? That’s a personal choice, probably determined by the risk profile, given your age and comorbidities. Some people, seeking improved protection, have been getting a second dose after being vaccinated by Johnson & Johnson. I wouldn’t blame you for getting that shot, and multiple studies and real-world experience have shown that you’ll be fine, but that path hasn’t been recommended by the Centers for Disease Control and Prevention.
Will we need booster shots?
I was optimistic about the long-lasting effectiveness of the vaccine. Why?
Well, because the antibodies have tended to last pretty long in cases of previous infections. For example, here’s a study of month-to-month antibody levels in people infected in New York City.
There’s a clear decline there among the various groups, but they still stay pretty high — probably not enough to recommend booster shots to everybody.
Because we didn’t have a vaccine for nine months of the pandemic, we have more data on the previously infected than we do on the vaccinated antibodies. But a study out of Israel looked at the issue and found more breakthrough infections from those who were vaccinated early in the pandemic than those who were vaccinated recently. That study split 1,911 breakthrough infections into early-vaccination and late-vaccination groups, and found that the likelihood of breakthrough infections was 53% higher in the early group.
Is a 53% increase enough to cause concern? Well, not by itself. We’d want to know the increase in hospitalizations and deaths, something that the Israel study didn’t have a statistically large enough sample size to examine. But it does give us something to watch moving forward. If that number turns out to grow by year’s end, or hospitalizations or deaths increase, too, then a yearly shot, like with the flu, might make sense.
That would also depend on the rate of mutation for the virus. So far, our vaccines have done extremely well, still mounting an impressive level of protection against the various variants that we’ve faced. It’s imaginable that a new variant could cause even more problems, though, so we’ll have to be on the lookout for that. However, it still looks like any regularly scheduled coronavirus vaccine would be more effective than the flu vaccine, so that’s good news.
Andy Larsen, one of The Salt Lake Tribune’s Utah Jazz beat writers, doubles as a data columnist. You can reach him at firstname.lastname@example.org.