Seriously, FDA?
The Food and Drug Administration decided yesterday to strictly limit”who can receive Johnson & Johnson’s COVID-19 vaccine.” Why? Because of “the ongoing risk of rare but serious blood clots.”
How rare but serious? Matthew Perrone and Lauren Neergaard, in “FDA restricts J&J’s COVID-19 due to blood clot risk,” msn.com, May 5, 2022, write:
Federal scientists identified 60 cases, including nine that were fatal, as of mid-March. That amounts to one blood clot case per 3.23 million J&J shots administered, the FDA said Thursday. The vaccine will carry a starker warning about potential “long-term and debilitating health consequences” of the side effect.
Since 9 out of the 60 were fatal, that amounts to 1 death from a blood clot out of 21.5 million shots.
What’s next? The Department of Transportation telling us not to drive because there are 1.34 fatalities for every 100 million vehicles traveled?
READER COMMENTS
vince
May 6 2022 at 5:13pm
Haven’t Pfizer and Moderna vaccines caused deaths, particularly from myocarditis? I’ve long wondered whether Pfizer is being held to the same standard as the other. It has the stink of politics. Why doesn’t the US offer more choices out of the many other Covid vaccines, such as Novavax. Incidentally, it appears that after 3 does, Sinovac outperforms Pfizer.
Joel Pollen
May 6 2022 at 10:58pm
I believe the FDA is not permitting those other vaccines because they have a general stance against using studies conducted primarily outside the US (and particularly outside the West) to get drugs approved. There are many differences between people in Pittsburgh and, say, Delhi. Genetic differences, sure, but differences on many other levels. That can have large effects on the population-level efficacy and safety of a drug. For example let’s say a certain drug causes people with pre-existing hepatitis to get really sick (actually true of certain monoclonal antibodies). If hepatitis is endemic in one country but very rare in another, the safety of that drug is totally different in those different places.
vince
May 8 2022 at 7:47pm
Sometimes it’s good to discriminate;) Also, experiments in those countries should count more than animal studies.
The FDA should do some research of its own on them, to give us choices. Stinks of politics.
Mark Bahner
May 6 2022 at 7:42pm
This is way outside my areas of expertise, but this blog post compares Johnson and Johnson (JnJ) vs mRNA vaccines, and finds JnJ looks pretty good:
Review of Danish study of mortality effects of mRNA vaccines
JFA
May 7 2022 at 7:59am
What the study did was look at RCTs from the vaccine trials and then calculate mortality risk (not mortality rate since follow-up time was reported inconsistently, which is one reason why we might put much weight on the findings). The adenovirus individual studies (except for J&J) are all nonsignificant for mortality (not a deal breaker but something that should be considered). Most of the mRNA trials that are presented in the paper’s table (>~85 of participants) took place in the US. Adenovirus vaccines were <~15% (I’m eyeballing on that one). The results do seem driven by J&J, for which the median followup was 58 days; for Pfizer the average follow-up was 108 days; Moderna had a median follow-up of 5.3 months. The number of cumulative follow-up days in the mRNA group is 1.6 times more than the adenovirus vaccines. The paper reports deaths per person years only for control groups. Why not for the treatment group? The differences in mortality rates and risk for the control groups and the difference in reporting periods makes me think people shouldn’t make a big deal out of these results.
Mark Barbieri
May 6 2022 at 8:07pm
Why is this not a pro-choice issue? I’d love to fix the upcoming Roe reversal with an amendment that says that everyone has the right to control their own body, including having an abortion, but also choosing what medications they decide are sufficiently safe and effective. Let the FDA continue their work, but restrict them to giving guidance, not commands. Let’s take the “It’s a Free Country” stuff seriously.
Joel Pollen
May 6 2022 at 10:50pm
David, I don’t think your analogy of not driving is right. The alternative to the J&J vaccine in the US is not no vaccine, it’s a different vaccine. So it’s like the government telling you not to drive a certain model of car because it’s less safe that other models. That seems less crazy.
Ford or Toyota aren’t trying to sell death traps from which the regulators save us. They prohibit some slightly less safe cars in favor of slightly more safe ones.
So perhaps restricting J&J is inefficient, but it’s not all that different from all the other forms of “consumer projection.”
David Henderson
May 7 2022 at 10:16am
You wrote:
Good point.
My criticism still holds, though, over innumeracy. There ARE differences in safety between cars. Saabs were noticeably safer in collisions than the average car. But the NHTSA didn’t prevent people from buying average cars.
Mark Brophy
May 8 2022 at 5:03am
The real story is that the J&J clot shot has killed many more than 9 people, they’ve killed thousands, as have the Moderna and Pfizer products. The “vaccines” have killed more people than they’ve saved.
JFA
May 8 2022 at 8:45am
Links? Evidence?
vince
May 8 2022 at 7:41pm
I would like to see evidence too, and not just one-sided. I can say anecdotally, from those around me who have been vaccinated, significant adverse reactions are much higher than the official statistics. I suspect many others have seen it that way too.
Thomas Lee Hutcheson
May 7 2022 at 5:35am
Your criticism surely seem correct, but doesn’t the complete analysis ALSO depend on the estimate of relative risks and benefits of J&J v others.
Jon Murphy
May 7 2022 at 8:47am
Only for the subjective analysis of the individual comparing different options. Relative analysis cannot be done at the aggregate level given the subjectivity of costs and benefits
J Mann
May 12 2022 at 11:35am
I’ll go one step farther. What’s the background risk of death by blood clot for the population studied?
Comments are closed.