A Blog by Jonathan Low

 

Apr 25, 2021

Restoring J and J Vaccine Was Correct, But Some People Should Avoid It

Of the 15 people adversely affected by the J&J vaccine, thirteen were women under the age of 50. 

The point of accumulating such data is to encourage targeted responses to the threat. Given the concentration of demographic factors, those at risk should be directed to the several alternative vaccines available. JL

Leana Wen comments in the Washington Post:

Of the 8 million Johnson & Johnson vaccine doses administered in the US, there were only 15 total confirmed cases of this rare combination of CVST and low platelets. Of the 15 cases, 13 were in women under the age of 50, with a median age of 37. Of the 15 women with TTS after vaccination, seven remain hospitalized, four in critical condition. Three have died. For younger women, the CDC needs to be much more explicit to warn them against the Johnson & Johnson vaccine based on the very rare but very severe risk associated with it

Friday’s vote by an advisory committee to the Centers for Disease and Control Prevention to resume administering the Johnson & Johnson coronavirus vaccine was the right decision, but with a serious mistake: There should be an explicit warning against the vaccine’s use in women under the age of 50.

I’m in this group. I’m also a participant in the Johnson & Johnson clinical trial who was told that I’d received the placebo. I then opted to get the Johnson & Johnson vaccine. If I knew then what I know now, I would have chosen the Pfizer or Moderna vaccines instead.

In the past few weeks, much has changed in our knowledge of the Johnson & Johnson vaccine. On April 13, the CDC and the Food and Drug Administration issued a pause on administering this vaccine after six reports of a very rare and serious blood clotting disorder, a blood clot in the brain called cerebral venous sinus thrombosis (CVST), combined with thrombocytopenia, or low platelets, the cells that help blood clot. On April 14, the CDC advisory committee decided that it needed more information before reinstating the vaccine. Specifically, it wanted to see how many more cases of this clotting disorder would emerge after the public became aware.


These were prudent steps, important to preserve public confidence in vaccine safety. The committee found that out of the nearly 8 million Johnson & Johnson vaccine doses administered in the United States, there were only 12 total confirmed cases of this rare combination of CVST and low platelets. Broadening the criteria to include all blood clots (not just in the brain) and low platelets, a condition called thrombosis with thrombocytopenia syndrome (TTS), there were 15 cases.The initial six cases all occurred in women between the ages of 18 and 49. The new reports were also all in women. Of the 15 TTS cases, 13 were in women under the age of 50, with a median age of 37. Of note, only two women were on oral contraceptives (a known risk factor for blood clots), and there were no other reasons identified as to why these individuals were likely to develop this rare condition. The only commonalities identified were their age and gender — and recently receiving the Johnson & Johnson vaccine.

It’s important to put the risk of TTS into perspective. Fifteen cases out of 8 million is a risk of less than two in a million. In women under 50, this risk rises to about 1 in 80,000. The CDC estimated that for every 1 million doses of this vaccine given in the under-50 female group, it would prevent 657 hospitalizations and 12 deaths. In women over 50, a million doses would prevent 4,794 hospitalizations and 593 deaths.

All of this more than justifies the decision to allow the Johnson & Johnson vaccine to be administered once again. In recognition of the risk of TTS, the FDA says that it will add information to the vaccine’s label that alerts people to its signs and symptoms. This is particularly important because the standard treatment for blood clots, administering the blood thinner heparin, is dangerous and can be fatal when there are low platelets.

But this is not enough for the highest-risk group of women under age 50. We are not talking about run-of-the-mill blood clots here. TTS is a severe, life-threatening illness afflicting otherwise healthy, young women. Of the 15 women with TTS after vaccination, seven remain hospitalized, four in critical condition. Three have died.

If there were no alternatives, the benefits of the Johnson & Johnson vaccine would surely outweigh the risks. But that’s not the case. There are two other very safe and effective vaccines that do not pose any risk of TTS. Why not issue a warning that advises women under 50 to receive one of these two other vaccines instead?

In the CDC deliberations, those against a targeted warning pointed to precedent — other common vaccines also have rare side effects. Some also noted the advantage of a one-dose vaccine for those who wouldn’t return for a second shot.

I am not saying that women under 50 shouldn’t be allowed to get the Johnson & Johnson vaccine if that’s their preference. There are plenty of people who would choose a one-dose vaccine because they have needle-phobia or do not want the inconvenience of a second shot. There are those who think the messenger RNA technology used for Pfizer and Moderna is too “new.” Although there are many arguments to reassure them of safety, some might still opt for a more “traditional” vaccine like the viral vector technology used by Johnson & Johnson. Clinicians concerned that their patient won’t come back for a second vaccination might also recommend this one-dose inoculation. But the default position should be against administering the Johnson & Johnson vaccine to women under 50.

In many parts of the United States, vaccine supply already exceeds demand. People should be empowered to decide which vaccine to get based on the risks, benefits and alternatives. For younger women, the CDC needs to be much more explicit to warn them against the Johnson & Johnson vaccine based on the very rare but very severe risk associated with it — and, critically, to direct them to alternatives that don’t carry this risk at all. After all the emphasis federal health officials put on prioritizing safety, it’s what we should expect from them.

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