COVID Transmissions for 3-1-2021

Johnson & Johnson vaccine reviewed, authorized, and recommended

Mar 01, 2021

Good morning and welcome to COVID Transmissions.

It has been 469 days since the first documented human case of COVID-19. I feel as though Bill S. Preston, Esq. and Ted “Theodore” Logan would have quite a lot to say about that number.

Instead, I’m thinking about how we are back in March. By now, a year has passed since most people started to realize this was going to become not just an epidemic in China, but a pandemic. If you’re like me, seeing March come back up on the calendar may feel a little like this:

Image is Bill Murray reporting in Groundhog Day, with the meme-formatted text “Well it’s March (top) / Again (bottom)” — Image is Bill Murray reporting in *Groundhog Day*, with the meme-formatted text “Well it’s March (top) / Again (bottom)”

Some of us have been living in a perpetual March, and I think it’s worth recognizing just how hard that is. The pandemic has come with a lot of time for us to stew with our own thoughts and anxieties, in between worrying about when it will ever end. I’m sure you are all fatigued.

I am glad to say that it really does seem like we’re turning a corner, as I’ll emphasize in today’s headlines section.

As usual, bolded terms are linked to the running newsletter glossary.

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Now, let’s talk COVID.

Johnson and Johnson vaccine authorized in the US

The single-dose COVID-19 vaccine from Johnson and Johnson was, in a quick succession of steps, made available in the US over the weekend.

First, the Vaccines and Related Biologic Products Advisory Committee (VRBPAC) for the Johnson and Johnson vaccine recommended that it be authorized, in a 22-0 vote: https://www.contagionlive.com/view/fda-s-vrbpac-meeting-to-discuss-efficacy-of-janssen-covid-19-vaccine

Then, the FDA, acting on the advice of that committee, agreed to authorize the vaccine: https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine

And lastly, the CDC Advisory Committee on Immunization Practices (ACIP), which functionally is responsible for determining which vaccines US physicians and other practitioners routinely administer, recommended that this vaccine be used: https://www.cnn.com/2021/02/28/health/johnson-and-johnson-acip-meeting/index.html

This goes to show just how many different experts have to be consulted for a vaccine to be given emergency authorization—not even full approval. That would have taken more review. For reference, let’s remember that none of the vaccines have full approval in the US yet. All of them are operating under an Emergency Use Authorization, because that speeds the review and approval process. This does not mean the vaccines were rushed, though. These vaccines have a lot of data and there was a lot of development that went into them. Most of the acceleration came at the earliest steps of the process. I think the safety and efficacy clinical trials were all conducted for appropriate lengths of time, though perhaps outside of the pandemic there might have been slightly longer follow up (to around 6 months inside of 2 months).

Regardless, the Johnson and Johnson vaccine is now the third authorized vaccine in the US, and the only one that is effective after only one dose. We have discussed this vaccine in past issues and I won’t belabor the design it here (links below) but I do want to highlight that it is not only the first single-dose vaccine available in the US, but also can be shipped at normal freezer temperatures and stored for a long period of time at normal refrigerator temperatures.

It is substantially more stable in a refrigerator than the mRNA vaccines, which will be a big help to getting the vaccine into places that only have a small local clinic. There are a lot of these places in the US, and even more around the world, so this is really good news. Add to that the fact that it is single-dose, and that means we can vaccinate more people faster in more places than before with this vaccine authorized.

Unfortunately, manufacturing for this vaccine is going slowly and has problems. Only about 20 million doses are expected in March, with real production slated to begin in April.

I covered the initial clinical trial results here: https://covidtransmissions.substack.com/p/covid-transmissions-for-2-1-2021

And there was a brief discussion of the manufacturing issues in this issue: https://covidtransmissions.substack.com/p/covid-transmissions-for-1-15-2021

Manufacturing issues or not, it is completely amazing that we are just a year into this pandemic and we already have three working vaccines available in the US and about double that available around the world. This is unprecedented and I think it is maybe the second or third greatest healthcare achievement in history, with the others in the running being the advent of modern sewage and sanitation (hard to call this a single achievement, hence the uncertainty) and the eradication of smallpox.

We could really be turning a corner in this pandemic.

Masking and indoor fitness

Periodically, I like to share articles about indoor fitness and how you can do it safely. This focus is not because I am fitness-obsessed (in fact until January 2020 I hadn’t set foot in a gym for about four years), but because I think the pandemic has led to a lifestyle change that is harmful to human health and exercise is a good way around it. So I want you, my readers, to know about information about how safely engage in exercise.

As always, if you can exercise outdoors or in your home, I do still think this is your safest option. However, I do not think that it is necessarily so dangerous to use a gym that the concept is unacceptable. In New York City data released in the fall, it was reported that 0.06% of cases could be traced back to gyms. I expect that this is because gyms in New York have been requiring masks and distancing and have strict capacity limits with advance signups—all of these requirements are important to prevent the spread of COVID-19.

However, there are places where such requirements have not been enforced, as was highlighted in this article that made its way to me: https://www.self.com/story/indoor-fitness-classes-covid-19-outbreaks/amp

That article discusses, at least at the beginning, an indoor group cycling class in Hawaii in the summer of 2020. At that class, no participants wore masks but all participants were distanced; masks were not required. The instructor was infected with SARS-CoV-2.

Every single participant in the class caught COVID-19.

This is written up in a paper from the CDC, University of Hawaii, and Hawaii Department of Health, published in Morbidity and Mortality Weekly Report, that describes how the index case of the class instructor led to a total of 20 symptomatic secondary cases as well as several tertiary cases down the line because the original instructor infected a second instructor.

You can read the full paper here: https://www.cdc.gov/mmwr/volumes/70/wr/mm7009e1.htm

I think this outbreak study demonstrates the importance of masks in indoor spaces with athletic activity quite well. It isn’t the best methodology to compare these incidents with citywide data I cited earlier, but intuitively, it appears that the presence of strict protocols is better than their absence. If you’re going to an indoor gym, make sure people are masking and keeping their distance appropriately.

Potential for an RNA vaccine against malaria

This isn’t actually COVID-19 news, but without COVID-19, I don’t think we’d be talking about this.

Recently, a patent application was filed for an RNA-based vaccine against malaria. Malaria is the oldest human disease, because it may well be older than humans. It is estimated that malaria is 50,000 years old, and the first evidence of modern humans is around that old too. Now, the estimate for the age of malaria there is probably wrong, but so is also the estimate for how long “modern humans” have existed, so it’s hard to say who really came first. But what I can say with confidence is that malaria has been harming and killing humans for the entirety of human history and beyond, because “history” starts well after all this happened.

If an mRNA vaccine design is capable of ending the reign of malaria as a devastating disease, particularly in the global south where it is responsible for economic depression and death, then it will be a truly great achievement. That achievement will be possible because of the successes we have seen with COVID-19 vaccines using these technologies, which opened the door for this kind of approach to be considered viable. Work on other RNA vaccines was already happening, but I think funding and attention are coming to these technologies far more than before because of the successes seen in COVID-19.

Of course, there are no guarantees. This vaccine candidate has not been tested in humans yet and it’s not clear it will work. But the fact that we are pressing on to prevent other terrible diseases using technologies first proven against COVID-19 is, I think, very good news.

A news story has been circulating that covers this, but I think you should be careful reading it. There are no data in humans with this vaccine, but the article claims that this is “the first vaccine to fully immunize against malaria.” I haven’t seen any evidence to support the claim of immunization; all I’ve seen is the patent application that the article mentions. The article also makes reference to a mouse study, but like I’ve said before, the old saying goes that “mice lie and monkeys exaggerate”; there is no true substitute for studies in humans.

A patent doesn’t mean the medicine works; it just grants exclusivity over it while it is tested and potentially after it is marketed. So read the article with a bit of skepticism: https://academictimes.com/first-vaccine-to-fully-immunize-against-malaria-builds-on-pandemic-driven-rna-tech/

This vaccine’s design is a little different from the mRNA vaccines we’ve seen used against COVID-19; it uses a “self-amplifying” RNA, which contains both instructions to produce vaccine-target malaria proteins as well as instructions to produce machinery that copy the vaccine RNA. This means a small amount of vaccine RNA can be delivered to produce a strong effect, but eventually the replication cycle runs its course and the vaccine RNA is destroyed by the innate immune system. It’s an interesting design that takes the mRNA vaccines’ basic concept—deliver the instructions for your target vaccine protein, and have the body produce that instead of supplying the protein itself—and takes it a step further. I hope it ends up working to fight malaria. If nothing else, it is an interesting exploration in science and a good story about how one success can pave the way for others.

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

Reading: Voices by Ursula K Le Guin

I’ve talked about the first book in this series—Annals of the Western Shore—in previous issues, and I’m on to the second book now. It shares some characters with the first book, but focuses on a young girl growing up in a city where a religiously zealous invading army has banned reading and ownership of books. This has very much grabbed my attention and I’m really enjoying the book. It still has the familiar, elegant style of Ursula K Le Guin’s fantasy work, as well, and that is always satisfying to read, because she was the first fantasy author I ever read. Reading something by her will always be like coming home again to an old friend.

I’m in the middle of it, though, so I can’t be sure I’ll love how it ends. I’ll keep you all posted, I suppose!

Robert Berger left the following comment, asking about the NIH Director’s blog entry that I shared in the last issue:

Regarding the NIH article you cited "Is One Vaccine Dose Enough After COVID-19 Infection?", the referenced study referred to people who tested positive for antibodies prior to getting the vaccine. This is just a subset of those people that were infected with COVID-19, and the article should have been more clear on this point.
The article raises the question of whether there is any substantive benefit to getting the second shot for those that tested positive for antibodies prior to getting the first shot. Two related questions then arise:
1. Is there any harm to giving the second shot to people that tested positive for antibodies prior to getting the first shot?
2. Is there any similar benefit/harm to people that recovered from COVID-19 but no longer test positive for antibodies?

Good questions! I don’t have a lot of answers here, I’m afraid. But I’ll try:

These are good questions, Robert. I do not know if I can reasonably answer them both. For (1), it is easy enough to say that one harm is having to have any potential safety events from the second dose of vaccine. Although they are few, they are still something that would be nice to be able to avoid. In the meantime, we also need to consider that if we reduced the number of shots required to vaccinate an antibody-positive person, we would free up those second doses for use in other people. So there is also a wider potential harm in terms of the supply crunch. Every two people who we don't have to vaccinate a second time leads to one more person who can get a full course--or two more people, if those additional two are also antibody-positive. So that's a substantial gain we'd be walking away from.
(2) I can't speak to this situation because I don't know of any data in such people looking at this. However, if they have an equivalent experience to those who have detectable antibody levels and thus require only 1 dose to be protected, then the answer to (1) applies. If such people without detectable antibodies are not able to get protection through 1 dose only, then the question is sort of trivial--obviously they would benefit more from 2 doses than 1.

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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