COVID Transmissions for 4-29-2021
Concerning problems with Sputnik V
Greetings from an undisclosed location in my apartment. Welcome to COVID Transmissions.
It has been 528 days since the first documented human case of COVID-19. 528 was a BIG year in the Byzantine Empire—the new Emperor Justinian I began a project to codify all of Roman Law.
Regulation is important to the proper functioning of every complex system. Today, a cautionary tale about that involving the Sputnik V vaccine.
As usual, bolded terms are linked to the running newsletter glossary.
Keep COVID Transmissions growing by sharing it! Share the newsletter, not the virus. I love talking about science and explaining important concepts in human health, but I rely on all of you to grow the audience for this, which you can do by using this button here:
Now, let’s talk COVID.
Sputnik V manufacturing standards are highly suspect
The Sputnik V vaccine made in Russia is turning out to have a lot of underlying problems. Although its described design as used in clinical rials appeared to be valid, it is becoming apparent that the marketed product is actually not the same as what was originally tested.
By now, many of you will have seen that Brazilian health authorities rejected the vaccine for approval in their country, despite a serious epidemic in that country. Several problems have been cited, including a lack of transparency on manufacturing processes, lack of access to data, and other issues. Something that I have not seen reported very widely, however, is found in this CTV story: https://www.ctvnews.ca/health/coronavirus/brazil-health-regulator-rejects-russia-s-sputnik-vaccine-1.5403539
In that story, there is a claim that regulators in Brazil determined that it is possible for the adenovirus vector used in the Sputnik V virus (described here: https://www.nytimes.com/interactive/2021/health/gamaleya-covid-19-vaccine.html), which is not supposed to be able to replicate itself, is actually able to replicate itself. That is the opposite of how a viral vector vaccine is supposed to work. The point is that it’s not supposed to let the vector virus go through its life cycle in your body. The objective of the technology is to simulate virus infection, not cause an actual virus infection!
Virologist Angie Rasmussen explained this further on Twitter, and I’ve pulled out specific tweets from her thread that help explain:
Essentially, at some point during the manufacturing process, the adenovirus-5 vector that is used as part of the Sputnik V vaccine became just normal adenovirus-5. The vaccine as manufactured just infects people with a competent adenovirus, though apparently still one that expresses S protein from SARS-CoV-2. Now, look, adenoviruses are not usually very dangerous, and the vaccine probably still protects people from COVID-19, but that’s not the point. The vaccine was designed not to do this, and it somehow got accidentally altered during manufacturing to be different than it was intended.
This is a colossal error that should never have been allowed to happen. Meanwhile, the Russian position is that this is all propaganda and lies being driven by the US. Unfortunately, the claim does not hold up, because it was a Brazilian investigation that made this determination, and Brazil was not the only country to reject this faulty vaccine—Slovakia has also rejected it, citing differences between the shipped product and what was described in the clinical trials.
Avoiding this sort of disaster is why the US has such strict controls in place on pharmaceutical manufacturing and why it is taken so seriously when a vaccine has even the most remote apparent safety issue. The US has had drug manufacturing reliability problems in the past, and these problems have shaped a robust regulatory environment that catches these things before they happen.
Any responsible pharmaceutical manufacturer has these quality control processes in place. Such processes would have found this vaccine problem. I must conclude they are not in place in the facilities that manufacture Sputnik V, and so I cannot in good conscience recommend that vaccine to anyone. How can you trust a manufacturer that promises you a replication-incompetent virus vector vaccine and then delivers a recombinant, but functional, live virus? I can’t.
Which is a shame, because what they tested in their clinical trial was a really good vaccine. If only that’s what they manufactured.
Something that sticks out of this for me, though, is that it is proof of how ridiculous antivax conspiracy claims really are. Vaccines are extensively tested, both by their manufacturers and by the countries and entities that purchase them. The moment anything suspect is detected, the alarm is raised. If, as conspiracy theorists claim, the legitimate vaccines on the market had some secret nefarious technologies included in them, it would have been discovered in short order by the thousands of watchful eyes monitoring drug safety in every country. We know this because when there is vaccine like Sputnik V, that does not have the ingredients it promises to contain, it is discovered quickly and rejected.
What am I doing to cope with the pandemic? This:
Enjoying the weather
Today in NYC it was around 70-80 degrees F. It was sunny and gorgeous. I got out, biked around, went to Hudson Yards, and saw people getting vaccinated at the Javits Center. It feels like, as cases fall this spring, life is opening up again for real. People are out and about and enjoying themselves safely.
It’s such a relief to see this, finally.
Reader Sam followed up on their (Sam—not sure of your pronouns, sorry) prior comment with this:
Thanks for your thoughtful response to my inquiries. A couple follow-ups:
1. Is there a plausible mechanism by which COVID vaccines could cause an autoimmune response further down the road, rather than fairly soon after vaccination?
2. If your hypothesis is correct, and long COVID is caused at least in part by a less-than-ideal immune response, would we then expect breakthrough cases to be less likely to develop into long COVID? (I've seen very little on the topic of breakthroughs and long COVID, but here's what Akiko Iwasaki had to say on the topic: https://dearpandemic.org/will-vaccines-prevent-long-covid/).
Good questions, again. My reply:
1) No. The vaccines express S protein in the body transiently and then stop. Reactions to them will mostly start within 2 weeks of their administration, though I would believe it possible for reactions to emerge within 6 weeks. When regulators and experts reviewed these vaccines for approval, one item that was considered was whether it was possible for a delayed reaction to a vaccine to emerge. A comprehensive review of vaccine trials was performed to understand this. The finding, according to Dr. Paul Offit, noted vaccine expert, was that they were unable to find any instance in which a vaccine adverse reaction emerged more than 6 weeks after vaccination. That is not to say that all adverse reactions resolve within 6 weeks—some are longer term—but there was no reaction they could identify that emerged for the first time after 6 weeks had passed. This makes sense, because by about 6 weeks after administration, the complete immune response to the vaccine has probably run its course.
At this time we have plenty of people who have had 6 weeks and more of follow up after vaccination, and no such reactions have been detected, so if something like that were to happen, it would be an unprecedented historic first (and I would also struggle to explain how it could possibly happen).
2) I’m actually not sure what my hypothesis about long COVID is anymore. I’ve read the cited thread by Dr. Iwasaki and it made me even less certain of what I think. I try to speak of possible mechanisms for long COVID because it’s very possible that many different things are going on and combining to cause this syndrome.
That said, if long COVID is encouraged in part by virus-mediated disruption of the immune system, then I think that it could be possible for a vaccinated person to be more protected from long COVID *even if* they still get COVID-19, because the vaccination might have primed such people to have a more coherent memory response. We know already that these vaccines reduce the odds of severe disease more than they reduce the odds of disease at all, which is suggestive of a continuum of quality of immune responses to vaccination. It would not surprise me if there were a step along that continuum where cases of long COVID are prevented but acute disease is not.
I would not, however, *expect* this to be the case, because I don’t have a specific hypothesis about the causes of long COVID that would predict this to be the case. I have only a number of different competing, not even mutually exclusive possible contributing factors to the development of long COVID. I may not have made that clear enough in my last response to you, and thanks for the opportunity to clear that up.
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.
Join the conversation, and what you say will impact what I talk about in the next issue.
Also, let me know any other thoughts you might have about the newsletter. I’d like to make sure you’re getting what you want out of this.
Part of science is identifying and correcting errors. If you find a mistake, please tell me about it.
Though I can’t correct the emailed version after it has been sent, I do update the online post of the newsletter every time a mistake is brought to my attention.
No corrections since last issue.
See you all next time.
Always,
JS
As I mentioned to John in email, Gameleya is also claiming that the Sputnik 5 vaccine is over 97% efficacious, which is, let's say, highly implausible. At this point they're going into Cold War parody-level "Russia is the best at everything" level propaganda.
https://www.washingtonpost.com/world/2021/04/27/sputnik-vaccine-brazil-russia-coronavirus/