Health experts concerned J & J vaccine issue could increase immunization hesitancy

Posted at 3:51 PM, Apr 14, 2021
and last updated 2021-04-14 17:42:20-04

(WXYZ) — As federal officials investigate Johnson & Johnson’s vaccine and a possible link to rare blood clots, health experts are concerned that vaccine hesitancy could increase. Chief Health Editor Dr. Partha Nandi discusses whether he thinks this could undermine American’s confidence in COVID vaccines?

Dr. Nandi:
This should absolutely not undermine the public’s faith in coronavirus vaccines. In my opinion, this pause in using Johnson & Johnson’s vaccine should instill more confidence in the FDA. Because they are being very diligent and putting safety first. They're also being transparent about what they’re doing. And what they’re doing is scrutinizing 6 specific cases to see if J&J’s one-shot dose is causing cerebral venous sinus thrombosis. That’s the fancy scientific term for these blood clots that form in the brain’s venous sinuses. They’re also looking to see if any other cases of blood clots exist. But again, I want to stress that the FDA and the CDC are very stringent. And this pause shows just how serious they are about keeping Americans safe.

Question: Why were these potential complications not caught earlier? Is this a sign that the clinical trials were rushed?
I’ve heard those exact questions from my patients. And here’s what I’ve told them, the clinical trials were not rushed. There were no shortcuts taken. Safety has been assessed every step of the way. With J&J, their trials had roughly 44,000 participants. That’s a lot of participants. But when it comes to rare complications, for instance, if J&J’s vaccine is linked to these blood clots, then there have only been 6 reported cases out of 6.8 million people who’ve received the vaccine. That’s less than 1 in a million. So that just shows that rare complications are not likely to show up in the initial trials.

Question: What do you want to say to people who are nervous about or reluctant to get a COVID vaccine?
First of all, it’s not uncommon for vaccines to be paused. That just means the safety surveillance system is working. So don’t let that scare you. Also, when it comes to these rare complications, I have two examples to help with perspective. For instance, roughly 1 in 1000 women who are on birth control pills develop a blood clot. And another common medication, Lipitor, has a 1 in 100,000 risk of developing a serious syndrome called rhabdomyolysis. That’s when muscle fibers die and enter the bloodstream. In rare cases, rhabdomyolysis can cause death. So when you compare those examples to a possible 1 in a 1 million chance of developing a blood clot, well it just shows you how rare this is. But again, the FDA and the CDC are scrutinizing these cases. And if they see a link, then I expect them to place restrictions on the vaccine. Again, they take safety very seriously. They are not out to harm anyone. They want to keep people safe. And I believe they are doing their best to keep people from getting infected with the virus. And from developing possible long-term health complications, and from dying from COVID-19.