COVID Transmissions for 10-18-2021

If you're a J&J vaccine recipient, it will soon be time to get a booster

Greetings from an undisclosed location in my apartment. Welcome to COVID Transmissions.

It has been 701 days since the first documented human case of COVID-19. In 701, the Japanese Imperial Court formed its “Bureau of Court Music,” the Gagakuryo, which organized arts performances at court.

Today we’ll discuss an alarming decline in J&J single-dose vaccine effectiveness in one study, and then we’ll discuss the FDA advisory committee recommendation that the J&J vaccine be boosted in all recipients. The latter makes me feel a lot more comfortable about the former. Also, at the tail end of that, a very short discussion of mixed-dose vaccination.

Have a great week!

Bolded terms are linked to the running newsletter glossary.

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Now, let’s talk COVID.

Veterans Health Administration study shows decline in vaccine effectiveness

A study of 620,000 veterans in the US, looking at vaccine breakthrough cases, has displayed a steady decline in vaccine effectiveness in the US:

Overall vaccine effectiveness against infection was assessed in this population, something which I continue to find annoying. Infection does not equal disease. If you are vaccinated, and you get infected, but you don’t get sick? The vaccine worked! That’s what it is supposed to do. It is supposed to stop you from getting sick. This paper didn’t look at that, so we really need to keep this in mind.

Still, protection against infection means that for certain, the vaccinees cannot be spreading the disease, so it is somewhat useful to know how protected people are against infection whatsoever. But protection against infection, while sufficient to prevent transmission, is not actually necessary to prevent it. Transmission is caused by a series of events that happen after infection. It can be disrupted by the immune system at points subsequent to infection also, so the vaccines can still stop someone from spreading the virus even if they do not stop that person from becoming infected. If you can stop infection, you certainly stop transmission, but that is certainly not the whole story. It’s like the Dodgeball movie line “If you can dodge a wrench, you can dodge a ball.” While, yes, this is true, you don’t actually need to be able to dodge a wrench in order to dodge a ball. The condition is sufficient, but it’s far from necessary.

Stepping off my soapbox on that particular topic, let’s look at the meat of what this study showed, through this key figure:

Image shows three lines that are representative of protection from breakthrough infection (y-axis) over time (by calendar month, x-axis) in people vaccinated with the Moderna, Pfizer, or Janssen (J&J) vaccines. The risks are relative to unvaccinated people, so the numbers here are similar to vaccine effectiveness. Each line shows a slow but accelerating decrease, with the Moderna protection decaying the least between March and August, the Pfizer vaccine tracking closely but worse than Moderna, and the J&J vaccine declining quite extremely.

Here we can see a gradual decline for all of the vaccines, but it accelerates over time. The J&J vaccine—as a single dose-regimen—has the biggest decline, which is alarming to me. Other data have suggested that this vaccine’s effectiveness does not decline much, but those data were looking at different endpoints, so that may explain the difference. I don’t want to start claiming that the J&J vaccine is down to 3% effectiveness for real—this is just one study, and that’s just one time point with a really wide error bar—but that’s eyebrow-raising.

Looking at it more widely, this study is like the much larger New York state study that I shared last week, in that it also shows the decline is regardless of various baseline demographic features, particularly age. Age is an important one to look at because vaccine eligibility was phased in according to age—so, like in the NY study, if the decline were due to something like the patients’ immune systems, we would expect it would not be uniform with respect to age. Older people would decline more by the same calendar month, because they were vaccinated earlier. That is not seen here.

Instead, something else must be the explanation. The authors of the study suggest that the Delta variant is responsible, but we can’t blame the Delta variant for everything. Human behavior also matters, and the country has gotten a lot more lax about COVID-19 protection protocols, particularly between June and August, when the decline in effectiveness in that graph starts to really accelerate for all of the vaccines. I’m not saying Delta didn’t play a role, but no virus spreads on its own.

If I scared you with the comment about J&J effectiveness, please do read on.

FDA panel recommends Johnson & Johnson vaccine booster dose

I’ve been eagerly waiting for this, and now we have it: the FDA’s vaccine advisory panel has unanimously recommended that a booster dose for the Johnson & Johnson vaccine be given:

Unlike booster doses for the 2-dose mRNA vaccines, this is a case where the original vaccination was not a prime-boost series. Instead, the J&J vaccination, as many will be aware, was “one and done.” This prime-only approach is unusual; there are few vaccines intended to confer long-term immunity that can do so with just a single dose. When such vaccines are developed, they generally become objects of intense study, because they are awfully difficult to make.

The recent completion of a study on a prime-boost regimen for the J&J COVID-19 vaccine showed that if spaced out between 2 months and 6 months apart, a booster dose could elevate efficacy against COVID-19 to over 90%, similar to what is seen with the prime-boost mRNA vaccine approach. I covered this in a recent issue:

COVID Transmissions
COVID Transmissions for 9-23-2021
Greetings from an undisclosed location in my apartment. Welcome to COVID Transmissions. It has been 673 days since the first documented human case of COVID-19. 673 saw the birth of Bede, a chronicler and monk who later became an important source on English history and religion…
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This came with no new safety issues, so this was a pretty obvious win. In fact, I’ve heard some folks saying that the J&J vaccine always should have been two doses. I’m not sure that I agree with that. Firstly, the vaccination schedule is actually really important. I think that it matters that the doses are given months apart, and I appreciate J&J’s willingness to test both one dose, an approach that could be used in the short term, as well as a two-dose regimen. This got the vaccine on the market where it was able to provide protection, but here we are about 6 months after it first became available and they’ve provided us with data that it’s a good idea to get a booster dose around 6 months later. Good timing! Many folks had the opportunity to be protected by this vaccine who might not have been if the 6-month-long 2-dose schedule had been what was initially tested without any single-dose trial being performed.

Unlike the other booster recommendations that were made this week, the recommendation here isn’t in particularly high-risk people. It is for folks 18 & up who had one dose of the vaccine already—in other words, anyone who got this vaccine.

I’m really happy to have this news, and it comes not a moment too late. The study that I led with today suggested that by August, vaccine effectiveness for a single dose of the J&J vaccine had fallen to alarmingly low levels—less than 20%! While I would not take any one study as definitive on this matter, I think even if there’s a chance this one has the right picture of the data, it underscores the need to boost the J&J vaccination. I’m glad the FDA advisory committee came to this recommendation.

These recommendations still need to be formalized into the vaccine authorization by the FDA, and then the CDC’s American Committee on Immunization Practices needs to review and recommend the boosters as well, but I expect all of those things to be formalities at this point. Within a very short time I anticipate the recommendation will be formalized and second doses will be rolling out.

A question that was raised in the discussion, however, touches on what we discussed on Friday—what about mixing doses of different vaccines? I wrote about this last issue. As it turns out, the committee also discussed this (though did not come to a recommendation). See a NYT summary of that here:

What am I doing to cope with the pandemic? This:

Watching: Foundation

I’m still on an Apple TV kick, and they bought the rights to adapt Isaac Asimov’s Foundation series into a show. To be honest, I was skeptical of how you could adapt a series like that to TV. It takes place over hundreds of years with many different characters, and is about the fall of an empire.

What I’m finding a few episodes in is that, well, it is off to a very slow start and is incredibly disjointed. I’m not too sure I can recommend it yet, but I’m going to stick it out and see if it gets better.

I received a couple of comments back from people who are also loving For All Mankind, so if you didn’t want to take my recommendation, take theirs!

You might have some questions or comments! Send them in. As several folks have figured out, you can also email me if you have a comment that you don’t want to share with the whole group.

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