CDC and FDA Against Johnson & Johnson Vaccine

U.S. Navy photo, Public domain, via Wikimedia Commons

Hmmm:

Federal health agencies on Tuesday called for an immediate pause in use of Johnson & Johnson’s single-dose coronavirus vaccine after six recipients in the United States developed a rare disorder involving blood clots within about two weeks of vaccination.

All six recipients were women between the ages of 18 and 48. One woman died and a second woman in Nebraska has been hospitalized in critical condition.

Nearly seven million people in the United States have received Johnson & Johnson vaccine shots so far, and roughly nine million more doses have been shipped out to the states, according to data from the Centers for Disease Control and Prevention.

“We are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr. Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, and Dr. Anne Schuchat, principal deputy director of the C.D.C., said in a joint statement. “Right now, these adverse events appear to be extremely rare.”

The Johnson and Johnson vaccine, like the AztraZeneca vaccine, is a viral vector vaccine. This technology — which uses a cold virus to deliver the genetic code of COVID-19’s spike protein — is relatively new. But four of the COVID-19 vaccines and two of the Ebola vaccines use it. Indications are that while it slightly less effective than the Pfizer/Moderna vaccines at preventing COVID completely, the Johnson & Johnson vaccine is equally effective in preventing severe cases and death.

Like the AstraZeneca vaccine, the J&J vaccine has some indications that it may cause an extremely rare and dangerous kind of blood-clot disorder. I wrote about this before in the context of the AstraZeneca vaccine and the same still applies: even if this effect is connected with the vaccine, the benefits of the vaccine far outweigh the potential dangers.

To be fair to the CDC/FDA, what they are recommending is a “pause” to assess what the risk factors are. I suspect that, like the AstraZeneca vaccine, the main risk factor will be low platelet count, which sounds contradictory since platelets are what cause blood clotting, so a low count should make clots less likely. So, the exact mechanism is a bit of a mystery. But if born out, that would indicate that dietary changes and monitoring could prevent this. A connection to low platelet count could also potentially explain why these clots are occurring more often in younger women, whose platelet counts tend to dip a bit during their menstrual periods.

I should note that the blood clotting thing may also be telling us something important about COVID-19, although what exactly it’s telling us is unclear. Our analysis of the virus has mostly focused, for obvious reasons, on its attack on major organs and destruction of people’s ability to breath. But I would not be surprised if a side effect of this side effect is a new insight into the how the virus works with potential benefits for treating it.

Given the low risk, then, why are the CDC and FDA making this recommendation? Well, the CDC and the FDA have a history and an organizational culture of being overly cautious on things like this, often to the frustration of people who desperately need drugs. Their attitude tends to be that they will get pilloried if they approve a medicine that turns out to be dangerous. But they won’t be blamed for failing to approve a medicine that would save lives. They are well aware that Frances Oldham Kelsey was lauded and given a medal for blocking the use of thalidomide in this country.

While this an improvement over the EU’s Keystone Cops approach, I still think the CDC is being overly cautious. We are in the early stages of a fourth wave of COVID-19, with Michigan in particular experiencing a dramatic surge in the new and more infectious variants. There is ample reason to warn people of the potential side effects. It is reasonable to suggest that young healthy women who are low risk be cautious or go for the Pfizer/Moderna vaccines. But suspending the use of the Johnson & Johnson vaccine right now — especially for Michigan — seems an over-reaction that is likely to get more people killed.

We are in the critical stages of our race between the variants and the vaccines. It is always a good time to keep track of side effects and make appropriate adjustments to our course. But this does not seem like one. We should keep stabbing people.