AstraZeneca approval in the US

So I’m reading this stuff and they mention that the JnJ vaccine uses similar technology, so I look up JnJ side effects and I find this:

The vaccine group reported 15 cases of “embolic and thrombotic events,” or blood clots, among 14 recipients, compared with 10 in the placebo group.

Uhhh. Should I be concerned? Need answer sort of fast.

Damned if I know. I’m trying to advise someone who is not yet age-eligible for the mass vaccination program with Pfizer/Moderna but can get the AstraZeneca, and all I can do is provide them with the latest medical advice I’ve been hearing (which is overwhelmingly “yes, get whatever approved vaccine you can”) as well as the kinds of articles that have been cited here, and let them make their own decision.

I will note that the difference between the blood clot incidents in the vaccinated vs placebo group for J&J is miniscule. But for the record, for whatever it’s worth, AstraZeneca and J&J (Janssen) are both viral vector vaccines. Pfizer and Moderna are mRNA. Viral vector, however, is the “traditional” known technology. It’s mRNA that’s novel.

I must admit a grim feeling of vindication. Five months ago any concern about a one in a million chance of bad effects vs the low dangers for younger people from covid was rather aggressively dismissed around here.

We’ll see how the adolescent and teen trials go for the other vaccines but we should not be shocked if they too have a one in a million problem for youngsters making the vaccine ethically dubious for them.

It’s a lot higher than a one in a million risk. It’s more like one in 100,000, according to the article I posted.

Well damn. I will go some hoops to go around the paywall.

But it certainly was frustrating when people thought 20k vaccine takers in the clinical trials was sufficient for us to not worry. A guy who used to work in the pharmaceutical industry was particularly dismissive.

I’ll grab the relevant part and quote it. But it is a really thorough and informative article, so worth reading in full if you can.

From the WaPo article I linked in post 293.

A total of 169 cases of CVST have been reported among 34 million people given the AstraZeneca vaccine across continental Europe and Britain as of April 4, the EMA said. In addition, there have been 53 other cases of rare blood clots. Although incident rates have differed from country to country, the regulator said that could reflect different reporting standards and estimated the overall risk to be about 1 in every 100,000 shots, in line with rates seen in Germany.

Thank you for the quote!

I came across a random piece of news. I had heard that AZ and Moderna were working on some projects together, including mRNA therapy for things very similar to CVSTs. I couldn’t quite pin that down but the interesting news was that AZ sold its 7.7% interest in Moderna earlier this year. That’s curious.

Either link to a specific conversation, or cut the “I told you so” nonsense. Because I recall some of those conversations, and they were not what your imagination would like them to be.

Nobody dismissed the possibility of very rare side effects based on studies of tens of thousands. What met pushback was any implication that the phase three study data gave us insufficient safety information to assess that the risk-benefit was heavily in favor or rolling out the vaccines immediately, given the severe effects of the disease and fact that the virus was rampant. And indeed, rolling out the vaccines (including AstraZeneca) has saved many lives.

So, as we accumulate data for a much larger number of people, we discover a rare side effect. And we may modify vaccination policy based on that new evidence. The risk-benefit of vaccination is indeed different for young people. But few young people were vaccinated before we accumulated sufficient data to identify rare side effects. So there is no “I told you so” here. Nobody has been harmed by ignoring your sage insights.

I would say 1/100 000 is a decently sizable side effect. We’ll see.

But if you want a link to a specific conversation, I was thinking of this:

Just had it today. No effects 11 hrs later. I did use a couple of drinks to thin my blood.

Unless you have reason to think you are at risk for clotting issues, I don’t think you should be concerned. It’s a pretty rare risk. Birth control pills also carry a risk of blood clots (I forget how great a risk, but it gets higher as you get older and if you smoke, and it got fairly substantial for older women who smoke) but people think the benefit is worth the risk. It probably is for you for this vaccine, too.

So what? How does that support your bogus “I told you so” narrative? What exactly were you “right” about that you imply others dismissed as impossible, rather than just part of the risk-benefit assessment given imperfect data? What should have been done any differently in the rollout of the vaccines?

I don’t have an “I told you so” narrative. I didn’t predict bad things. I was commenting on how dismissive some people were about the possibility.

how is it woeful? What should they have done differently? what decisions have they made that they shouldn’t have made? what have they failed to do?

To me this looks like exactly the way in which such decisions should be taken, completely open, apolitical, subject to change and based on a clear and understandable calculation of risk/benefit.

Not a hint of “I told you so” there, I’m obviously completely imagining it.

Deciding that our lack of knowledge of possible rare side effects did not justify delaying the vaccination program was not being “dismissive”. It was acknowledging the risk, but quantifying it and determining that the benefit vastly outweighed the risk.

So answer the question. Now that we do in fact know there IS probably a rare side effect, were we incorrect in that prior risk-benefit assessment? Should the vaccine rollout have been delayed?

compared to what? contraceptive pill? long-haul flight? risks from Covid?

There were three very useful charts presented in the UK which showed the relative and absolute risks for each age group regarding taking the AZ vaccine or remaining unvaccinated and potentially catching covid.

One of those charts is represented in this article.
You can see that the risk/benefit crossover at the moment only appears to be in the youngest group and at a very low level of infection.

Note, the calculation in this chart is done using a very low level of covid infection, (about half the current UK rate and perhaps 10 times less than Europe) the case for continued vaccine use is far stronger as the infection rate climbs.

It would seem to be the case. For example, in this article it is mentioned at the end, and today the Italian newspapers say the same. They are switching AZ to the over 60s, but say that if you’ve had the first jab without issues, you should have the second one as well. This is of interest to me, as I am slap bang in the risk group and have had one AZ jab. As things stand I would prefer having both jabs, rather than not finishing or having a untested mix of two difference vaccines. Actually, rationally speaking, I’d even get the first one again, if offered a choice between that and nothing else, even though I have to admit that as a hypochondriac I have had a terrible two weeks of it.

Thinking it was a mistake to pause the rollout of vaccine is not the same as being dismissive of the risk. Covid also causes blood clots.

The risks from covid to younger people.