The return of the Johnson & Johnson vaccine: Yahoo News Explains

The recommended pause on the use of Johnson & Johnson’s COVID-19 vaccine was lifted in the U.S. on Friday following a thorough safety review after cases of rare and severe blood clots were reported. Yahoo News Medical Contributor Dr. Kavita Patel explains what’s different after the pause, what the findings were and what the public should know.

Video Transcript

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KAVITA PATEL: The FDA, in conjunction with advice from the CDC, in a recommendation has lifted the pause and added a warning, a clinical warning specifically, for certain groups and populations to be at higher risk, potentially, of severe blood clots. In this case, likely women under the age of 50 might be given an option to think about, if you have a choice, another vaccine choice. And for clinicians, also some guidance about symptoms to look for, even in other people who might not have been identified as high risk but might return after a vaccine with severe headaches, severe abdominal pain, unusual swelling, or chest pain or shortness of breath. So it's a combination of advice to give clinicians who are giving people vaccines, as well as a warning so that you might have a discussion with your doctor about a different choice, if Johnson & Johnson is not the right vaccine for you.

So during the pause, there were a total of 15 cases that were identified with these very severe and rare blood clots, unfortunately, three of which died and seven of which are still in critical condition. And what that really adds up to is an incredibly rare risk, about 1.9 cases per million. And in-- the best way to compare it is that by limiting access to the vaccine, even potentially limiting access over the age of 50, which the CDC was considering at one point but chose not to do, that you would still actually be adding to the deaths in the population by not having that vaccine as a choice. So in other words, the risks were much lower than the benefits, and the benefits included preventing hundreds of deaths by being able to allow for the use of the vaccine in anyone over the age of 18.

So there is still no study that shows the link or the cause, for example. All we know is that this is associated in a higher degree in Johnson & Johnson and with AstraZeneca. So we do think it has something to do with the vaccine technology, but that has not been established.

There was no one factor that unified all 15 cases, other than they happened to all be women and all happen to be under the age of 50. But when you look further, there were several chronic conditions that people had-- thyroid disorders, obesity. In general, we think that especially in women, people with chronic conditions might be at an even higher risk.

But of course, there were still cases of perfectly healthy young women who did not take birth control, who did not seem to have any other risks, which highlights that if you have any symptoms after taking not just the Johnson & Johnson vaccine, but any of the COVID vaccines, there is a mechanism to report this. It's called V-Safe, something you can go online and make sure. And we hope that the public actually does this. Draw attention to any side effects, small or big, because that's how we learn more about these vaccines over the long term.

The CDC also reviewed data around just overall risks of blood clots, not necessarily exactly these types of blood clots. But even when you look for these specific, very rare brain blood clot, we do see a higher incidence in women, for example, who take birth control. So there is already a higher risk, as high as 10 people per million, in some cases, with other things like birth control. But again, with Johnson & Johnson, only about less than two cases per million people, making it overall not just a safe vaccine for COVID, but a very safe vaccine in general.

So three things the public should know, number one, the resumption of the distribution of the Johnson & Johnson vaccine, even with a critical warning, is still an affirmation that this is a very effective and overall safe vaccine. Number two, you should take the first vaccine you're offered. If you have a choice, it's worth having a discussion. But if you don't have a choice and there happens to be one of the three manufacturers, I highly encourage people to take it. Number three, we do know that people have side effects, some of them-- of which are very severe, and that they should talk to their health care professional to make sure that they make a safe decision.