UPDATED on 4/23: A few words about the Johnson & Johnson Vaccine
By: Center For Urban Community Services
Tags: Covidvaccination, New York, NYC, Covid Vaccine, Covid 19

Dr. Van Yu, CUCS Chief Medical Officer

Just before 5PM this afternoon(4/23), the United States Advisory Committee on Immunization Practice (ACIP) voted 10–4 to approve this recommendation:

“The Janssen COVID-19 vaccine is recommended for persons 18 years of age and older in the U.S. population under the FDA’s Emergency Use Authorization.”

This means that the ACIP is recommending to the Food and Drug Administration (FDA) that the “pause” on the J&J vaccine be lifted without restrictions. The FDA will almost certainly accept this recommendation. This means that the J&J vaccine should be available for administration to any American 18 years of age or older again as soon as this weekend. Although there will likely not be any limitations on the vaccine’s use, the FDA will likely add a warning to the Emergency Use Authorization. The wording of this warning has not yet been worked out.

What was all the fuss about?

Last Tuesday, April 13, the Centers for Disease Control (CDC) and FDA “paused” the J&J vaccine after the Vaccine Adverse Event Reporting System (VAERS) detected 6 cases of a very rare and unusual clotting disorder in people who had recently received the J&J vaccine. The disorder, which is now being called, Thrombosis with Thrombocytopenia Syndrome (TTS), is a combination of blood clotting (a thrombosis is a blood clot) with low platelets (a thrombocyte is a platelet, “penia” means low).

What’s unusual about that?

A person who is having a clotting disorder usually has a high or normal platelet count. Platelets are one of the blood components that form clots. So, it’s really unusual for a clotting disorder to develop in a person with low platelets.

Why did this discovery lead to a pause?

Thrombosis with Thrombocytopenia Syndrome can result in blood clots in parts of a person’s brain which can be very dangerous. Of the original 6 people detected by the VAERS, one person died and one required ICU treatment. Furthermore, because the disorder is so unusual, it can be difficult to diagnose unless you are looking for it, and the treatment is counterintuitive (a common treatment of clots, a medication called Heparin, can make the condition worse). So, the CDC and FDA elected to pause the vaccine for 4 reasons:

To carefully search for more cases to determine how prevalent the disorder is. To try to figure out how, or if, the vaccine is related to the disorder and what, if any, risk factors there might be. To alert medical providers about how to diagnose the disorder. To ensure that medical providers understand how to treat, and how not to treat, the disorder.

So, what has been determined?

In addition to the 6 cases detected by the VAERS, investigations since last Tuesday have uncovered 9 additional cases for a total of 15. 13 of these cases were in women 18–49 years old (out of 1.8 million doses). 2 cases were in women over 50 years old (out of 2.1 million doses). There were no cases in men (out of almost 4 million doses). Of the 15 people who have developed the condition, 3 have died, 7 are currently hospitalized, and 5 have recovered enough to be released from hospital. So, here are some rates to help you digest all this:

Rate of Thrombosis with Thrombocytopenia Syndrome in people who have had a J&J vaccine:

Women under 50 = 7 in a million Women over 50 = 1 in a million Men = 0 in 4 million

Although it does appear that there is a real association between the J&J vaccine and this clotting disorder, the mechanism behind the association is still not understood (partly because it’s so rare). Furthermore, although it also appears that this affects women more than men (and may not affect men at all), the reason for that is still not understood.

And, by the way, there have been no cases of TTS in people who have taken the Pfizer or Moderna vaccines.

Why did 4 people vote against the recommendation?

It appears that all 4 people who voted against the recommendation actually do agree that the vaccine should be unpaused AND available to everyone, BUT they would have ADDED this to the recommendation:

“women aged <50 years should be aware of the increased risk of TTS, and may choose another COVID-19 vaccine (i.e. mRNA vaccine)”

So, where does this leave us?

If you received a J&J vaccine more than 3 weeks ago you have zero reason to worry about this clotting disorder. All the cases developed within 2 weeks of administration. If you received a J&J vaccine less than 3 weeks ago, I still encourage you not to worry. This disorder is super rare. If you have any of these symptoms seek medical care:

Severe headache

Blurred vision

Severe abdominal pain

Chest pain

Severe leg pain or leg swelling

Unusual bruising

If you are a man and have not been vaccinated, the J&J vaccine still seems very safe and effective. If you preferred it over the Pfizer or Moderna vaccines then it seems to me it’s still reasonable to prefer it.

If you are a woman and have not been vaccinated, this clotting disorder does appear to be a real, albeit rare, risk. However, I do not think it’s unreasonable to choose the J&J vaccine. The risk of getting, and dying from, COVID-19 are still a lot higher than the risk of developing this disorder. The J&J vaccine is still the only single-dose vaccine available. On the other hand, you have options. It’s relatively easy to get a Pfizer or Moderna vaccine in New York City right now, and there have been zero cases of this clotting disorder associated with either of those vaccines.