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How to Handle Employees’ Questions about the J&J Pause

What employers need to know about the Johnson & Johnson vaccine pause...

Early on April 13th, the FDA called for a pause on administration of the Johnson & Johnson single-dose vaccine, after six people developed a rare adverse reaction involving blood clots.

Nearly seven million people have already received the Johnson & Johnson (also called J&J or Janssen) vaccine. While we expect that there may be a few more people who experience this rare clotting disorder in the next few weeks who have recently had the shot, it does appear to be extremely uncommon. 


What are the symptoms? 

Symptoms in the six people with this rare clotting reaction started generally between one and three weeks after getting the shot. Symptoms included severe headache, severe abdominal pain, leg pain, and/or shortness of breath. 


Flu-like symptoms, including headache, in the day or two after the shot is considered a normal immune response to the vaccine. These six serious responses started later than that, and were generally much more severe.


Couldn’t these be normal blood clots that would have happened anyway?

Maybe, but there is a strange pattern that the FDA and CDC noticed, where patients have blood clots and low platelets, which isn’t normal with blood clots. The real danger here is that normal treatment for blood clots (blood thinners like Heparin) could be harmful if someone has low platelets, so the FDA wanted to pause to gather more data, warn doctors to keep an eye out for it, and make sure they have all the information they need before resuming vaccination. These are also very similar reactions to what European agencies are seeing with the AstraZeneca shot, which makes it less likely to be random. 


I’ve heard this only affects younger women, or that it has something to do with taking birth control. Is that true? Should I be worried?

It’s reported that most of the people that had this rare clotting disorder were women ages 18-48, though there are so few of them (only six) that doctors and scientists can’t say for certain whether this only affects women or only affects that age group, or both. Some may have had underlying conditions, but not everyone did. Rumors that there’s a link to birth control are not substantiated, according to the FDA. Again, with only six cases out of nearly seven million recipients of the J&J vaccine, there are generally not enough cases to see any patterns with certainty.


Is this pause required or suggested?

The FDA recommends a pause, but stressed that it isn’t a mandate. Both the FDA and CDC have stopped any federally-run vaccination clinics that were scheduled with the J&J vaccine and are strongly recommending that states do the same. Early indications show that most states will likely follow suit - OH, NY, CT, and NE have already indicated they’ll pause J&J shots, with others doing the same throughout the day. 


What will happen to my appointment? 

Nearly nine million doses of the J&J vaccine were scheduled to be given out. Those appointments will likely be cancelled or rescheduled, and replaced by Pfizer or Moderna vaccines. 


I already got the J&J shot. What should I do? 

Don’t panic. The chances of this rare blood clotting disorder happening to you are less than one in a million. Only six people out of seven million had this. If you got the shot more than three weeks ago, you’re likely in the clear already. None of the six cases happened in the first week or more than three weeks after the shot. Keep an eye out for any extremely severe stomach pain, headache, or shortness of breath or leg pain. These can be dangerous signs of a blood clot. If you experience any of those, call 911 or go to the nearest emergency room, and be sure to mention that you recently had the J&J vaccine. If you’re just experiencing normal flu-like symptoms in the day or two after your shot, that’s likely just your normal immune response.

I already got the J&J vaccine. Do I need to get re-vaccinated with Pfizer or Moderna now? 

No. The J&J vaccine is still very effective. The concern here is that there might be a very rare blood clotting reaction in some people in the 1-3 weeks after they get the J&J vaccine. There is no concern around the effectiveness of the J&J vaccine. It still prevents severe cases of COVID and death. There’s no need to get another vaccine if you’ve already gotten a dose of the J&J. You’re still protected. 


Should I be worried about Pfizer or Moderna and blood clotting?

No. Nearly 120,848,490 Americans have received at least one dose of a vaccine, and the vast majority of those were Pfizer and Moderna, because they were approved first and are more widely available. There has been extensive monitoring of symptoms, and there have not been any cases of similar blood clotting related to these vaccines. 


Doesn’t this prove the vaccines aren’t safe?

No! This proves that the vaccine safety monitoring systems are working well, that the FDA and CDC are watching them closely, and that when there are possible patterns of adverse reactions, they will be transparent, pause vaccination, and take the time to study it. This must have been a very hard decision for the FDA to make, but they chose to take the most cautious route.


Will we be on track to reach the 200,000,000 vaccination goal for the U.S.?

Maybe. The White House has said that they expect we’re still on track to meet the goal. In a strange way, the Johnson & Johnson manufacturing delays of the past week may have helped with this, since they delivered about 85% fewer doses this week than last week. Still, there were nearly nine million doses scheduled to be delivered in the coming days and weeks, and rescheduling all of those will be a logistical and manufacturing challenge, to say the least. That being said, Pfizer and Moderna haven’t stopped producing their vaccines at full speed, so there should be enough to go around. We’re more concerned about the decreased confidence that some folks will have about getting the vaccine after hearing this news story, as opposed to actually having enough shots for them. 


What can I say to my employees who are concerned about the safety of vaccines after hearing the news? 

Emphasize three points:

  1. Pfizer and Moderna are extremely safe. Nearly 95% of the vaccines administered in the US so far are Pfizer or Moderna, and there have been zero cases of this type of rare blood clotting with low platelets. 
  2. The safety monitoring system worked exactly the way it was supposed to. Six people out of seven million had a strange reaction, and the FDA stopped all administration of the J&J vaccine to study it.
  3. The risk of dying from COVID-19 is still much greater than the risk of having any sort of reaction from the vaccine. More than 31 million people have had COVID in the US and nearly 1.8% of those people died from it, not to mention the huge percentage who had long-term effects. Compare that to .000086% of J&J vaccine recipients who have had this rare type of blood clot so far. 



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Disclaimer: This post is meant for general information and educational purposes only and does not constitute, and is not intended as, any form of medical, legal or regulatory advice or a recommendation or suggestion regarding the same.  No recipient of this information should act or refrain from acting on the basis of this information without first seeking legal advice from counsel in the relevant jurisdiction.