I wrote about this in other threads, but I listened to most of the ACIP meeting (the CDC Advisory Group) and I think they made the right decision. They were handed a s**t sandwich by the CDC/FDA’s abrupt announcement of a pause and were searching for ways to deal with it.
On the one hand, they were very concerned about the incidence of CVST and don’t have all the data necessary because they want to buy time for data to roll in from the other 3 mill or so J&J vaccinees who will complete the bulk of their vaccination cycles within 10 days to 2 weeks. They can’t really issue guidance limited to women 20-50 because they don’t actually know that’s the only potentially impacted group. In addition, the number of cases is so low that if there are no or few additional cases reported the incidence level may be so low as to make their guidance more limited and focused while giving J&J a green light.
On the other hand, extending the FDA/CDC’s abrupt pause would have a very damaging effect on the reputation of J&J. People who spoke at the meeting highlighted how valuable the vaccine has been to target harder to reach groups. More than 50% of those who have received J&J are under 55, demonstrating that this vaccine has real appeal where available to younger, more mobile folks. Every day that J&J is not available on the market has a real cost in terms of COVID infections and resulting deaths. J&J is easy to administer and the vaccination cycle to reduce risk is quicker.
So rather than fall in line with the CDC’s approach that we can afford the pause because we have Pfizer/Moderna (some wanted this approach, but they were persuaded by others not to down this road), they decided not to gratuitously blast J&J in the media and instead wait for the data from the group of J&J recipients who will complete the key portion of their vaccination cycles, issue guidance and hopefully recommend a green light.
I think this is the best result that we can hope for at this point. CDC/FDA did not thoroughly consider the cost-benefit analysis. They seemed to think the luxury of Pfizer/Moderna supply allowed them to err on the side of caution. ACIP was more skeptical of CDC/FDA’s reasoning and notes a significant risk to the public of damaging J&J like this and needs to gather the data to make a clear, reasoned decision that helps chart a path forward.
I saw articles about cases of this here in the US several weeks ago - including a doctor in Fla. that died from it and another doctor in the Boston area who got really sick from it (both of them suffered from platelet depletion rather than clots, but it’s still deadly.) I suspect that in order to be effective, the COVID vaccines skirt mighty close to the body’s platelet generating system.
In saner times all of these vaccines would be pulled until a better mechanism could be found to protect against the virus without killing otherwise healthy people, but we do not currently live in one of those times. However, as I commented over the past several days on other threads, this is not just a J&J problem despite the out-sized response.
Nobody does studies on millions of people. The reason we see this side effect (if it is a side effect) is because millions of people were vaccinated. This DIDN’T happen in trials because those were done on hundred thousands of volunteers. And that’s not big enough number for this side effect to show.
Turns out it did show up in one of the volunteers in the trial. J&J determined it was unrelated. That’s why CDC is now raking them over the coals, to see if there are any other “unrelated” side effects that J&J glossed over.
Based on A/Z findings it’s NOT a spike in numbers (statistically speaking). It’s about unusualness of the cases and their proximity to vaccine. I’m sure that 6 cases don’t spike averages here much either.
I’m afraid my cynicism kicked in here. Cui bono? J&J is cheaper, easier to ship and handle, and only requires one dose. It is a really attractive option as opposed to multiple jabs spread out over months, and appeals to many of us even though we are not drunks living under bridges. The press has done a good job of tarring the J&J vaccine as the preferred option for the socially incompetent. I think this pause will kill its viability in the US leaving the field open for the much more expensive Pfizer and Moderna jabs. And given that both Pfizer and Moderna have stated their intention to jack up their prices in the near future, I’m having a hard time separating the hype from the science.
The only issue I have is this:
Why downplay the CVT and ITP cases in the US with the mRNA vaccines and literally trumpet the cases all over the news with two vaccines that are much cheaper?
Both J&J and AstraZeneca have said they are selling their vaccine at a low price and don’t intend to make a profit on their vaccines. I just get the sense that there is a smear campaign going on to generate public distrust with the cheaper vaccines when the risks are similar.
The profit potential from these vaccines with annual boosters are going to be off the charts because they will become more expensive once we or our insurance companies have to pay for them.
I think all four vaccines should be used. They are a lot better than the alternative. I guess I was going to get the J&J vaccine because my appointment for Wednesday was cancelled. I’ll take any of the four vaccines. Makes no difference. I do prefer the J&J though because of the one shot.
Like the Oxford study discovered, 39 out of every one million will suffer from CVT due to covid-19. That’s a lot higher than one out of every million. And we know not all 39 are not going to survive, even if they get to the hospital in a timely manner.
I agree with your points about the benefits of J&J. The data show that J&J recipients skewed younger, significantly so. That has real value in terms of killing the spread of COVID, which is why I’m disappointed at the CDC’s approach (and Fauci’s). I think we are in a race against time (as ACIP folks indicated). There is a huge upside to the US to mass vaccinating over the next 4 weeks than the following 4 weeks. The UK kept up its vaccinations via A/Z and you can see the benefit.
My issue with CDC/FDA/Fauci is their reliance on this notion that this announcement demonstrates confidence in the integrity of their process and system and their assumption that we can rely on Pfizer/Moderna. It diminishes the seriousness of the crisis we face. They’re acting like this is about a bad batch of Tylenol. I also don’t care much for the CDC burnishing its rep. Last year they were trash. They only look decent at the moment because Biden is POTUS. The antivax crowd doesn’t care about the CDC’s rep.
On the economics of this, I think it’s just rational behavior on the part of Pfizer/Moderna. If regulators create scarcity, they will take advantage. I think the risk is that we’re hoping similar or comparable issues don’t arise in the mRNA vaccines. They’re not fool proof.
All good points, except for this. These vaccines didn’t get any shortcuts on safety testing. They did the full Phase I, Phase II, and Phase III testing on a compressed time schedule, with the companies proceeding ‘at risk’, without the usual pause between phases for data evaluation and consultation with the regulatory agencies. The Phase III trials used tens of thousands of subjects, which is about what they would have run in the course of ‘normal’ vaccine development. In the development of the PfizerGlaxo-Smith-Kline Shingrix (shingles) vaccine, the Phase III trials enrolled a bit fewer than 40000 subjects were tested, for example.
It is interesting, from what I understand that covid itself causes clotting, or fighting it does. So if you vaccinate against covid then the reaction to it just might be similar to the reaction to covid itself, in some people.
Vaccines are a societal good, and we as a society should compensate those who take a hit to keep the population safe. As long as the manufacturers are following current Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP), they should be shielded from liability exposure.
I don’t know the PREP Act provisions explicitly, but I’d be shocked to learn that current GCP and GMP were not required.
I agree with you. I was also slated to get J&J this week. I’ve been rescheduled with the two-step Pfizer, so instead of being done at the end of April, I’ll be getting a second shot in May and waiting until the end of May for full protection.
I agree that testing was not cut short and the Covid Phase III was as large as that for any vaccine on the market. No study is going to catch 1 in a million or even 1 in 200000 events. That’s why we have post-marketing surveillance.
Also, I should point out that the efficacy in the real world remains extraordinary. CDC has looked at 66 million people who have been vaccinated and found only 5800 breakthrough cases, despite all the variants currently circulating. That’s 1 in 10000.
A small correction-Shingrix is from Glaxo, not Pfizer.
