So, we’ve (that’s the CDC- Centers for Disease Control- and the FDA- the Food and Drug Administration) decided to hold off using the Johnson & Johnson vaccine. (And, we’ve (that’s the USA) never even considered using the ASTRA-Zeneca version of the vaccine.) Today is the day the authorities will release (pun intended) the J&J version from purgatory. (That is my prognosis. Below is my reasoning why.)
Both of these vaccines -the J&J and the Astra-Zeneca- have a very rare side effect- the development of blood clots in the brain. Both of these vaccines are similar in that they use modified adenoviruses (which means the virus is unable to replicate in our bodies). the scientific term for this sort of vaccine is it uses ‘viral vector’ technology. The issue before the reviewing committees is to determine if these viral-vector vaccines trigger platelet-activating antibodies- in very, very few or a potentially larger population.
And, before one condemns these vaccines completely, keep in mind that we were initially talking about 6 youngish (18 to 48 y of age) women developing blood clots (and maybe a disorder that inhibits clotting). (Further Note: 1 man developed this affliction during the clinical trials. And, the 11 day investigation rounded up a total of 15 afflicted patients.) Moreover, this condition may or may not be related to the vaccine.
That incidence is only 15 in some 8 million inoculations. Or about 1/2 per million inoculated! The other problem to be addressed by the panel: the normal therapy for this affliction is to use heparin (a blood thinner). However, this typical therapy actually exacerbated the blood clot conditions.
The negative response of the blood clot to heparin was a rare ailment first described in the mid-1950s; at that time is was termed heparin-induced-thrombocytopenia (HIT). This condition occurs when platelet factor 4 binds to heparin. After which, the body then reacts attack this heparin-platelet complex.
One should also recognize that the incidence of the blood clots means that such a condition would probably never have been uncovered during a regular clinical trial, let alone one run under conditions of the pandemic. (It’s simply too rare to be observed in a clinical trial. That is why all “approved” drugs are subject to continuous monitoring and adverse condition reporting!)
But, here’s a more important salient fact. The risk of contracting COVID-19 versus developing the rare blood clots is many orders of magnitude higher!
Moreover, the J&J vaccine is a one and done version. That means it is the perfect choice for the homeless, the essential worker (as in grocery stores, not medical centers), and those folks that are hard to reach. Because there was no need to return for another, subsequent shot.
It also means that the folks who got these J&J inoculations are harder to track. Because they have no need to come back for another dose. Moreover, the USA lacks a national healthcare monitoring system, so there’s no real way to track patients and their responses.
The only reason why the CDC knew about these clots is that the VAERS (Vaccine Adverse Events Reporting System) was used- and, even this system is an opt-in participation. (That means only those who elect to use the system so report- so we had no initial idea if there were even more than 6 folks affected.)
(The more ‘complete’ database is the Vaccine Safety Datalink (under the auspices of health insurers) that tracks about 10 million patients. Note the word complete is in quotes- because of the 7.5 million inoculated with the J&J version, less than 115000 of those folks were being tracked by the VSD.)
But, we can expect the J&J vaccination program to restart today. Of course, Emergent, the contract manufacturer that failed multiple FDA inspections is under new management. But, more importantly, the inventory of vaccines we thought were available all had to be destroyed! So, the J&J availability will be pretty low for a while.
I wanted J&J until I realized the potential danger of blood clots. I get the second Moderna on Sunday. Then I can go get a Shiatzu Massage, go visit some of my elderly friends, and even go to a restaurant. I’ve become a homebody, though. I wonder if I actually will venture out? Too many people is an assaught on my senses.
Glad you got the second dose, Kate! That means you now have choices- viable ones to protect yourselves and others- as we ease back into whatever will purport to be the new normal.
I’m very happy I did not get the J&J vaccine. However, I do worry that because of what has happened, many people will choose not to get vaccinated now.
I’m not sure you would have been at risk from the J&J vaccine. And, there is great value in a one-and-done vaccine, to boot. Finding the reason why these blood clots form- albeit as rare as they are- is still an important quest.
The pause was necessary but it’s such a shame it had to happen. I think there is now going to be a substantial avoidance of any initial doses of any 2 shot vaccine and the 2nd dose for those who already got the first dose, on the part of many who might have (reluctantly) been vaccinated. It couldn’t have come at a worse time. The J&J would have been so helpful, as you point out, to homebound, homeless, and other populations that needed a single shot.
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I think the convenience of a one-and-done and the extremely low risk won’t be a terrible impediment to J&J’s distribution. The biggest impediment is Emergent- a bad choice the feds made to produce the vaccine.