On April 13, 2021 the FDA recommended a pause in the utilization of the Johnson & Johnson Covid-19 vaccine. This recommendation is being made “out of an abundance of caution” and based on the occurrence of six women, all between the ages of 18 and 48, who were noted to develop a rare type of blood clot in the brain associated with low platelet counts. All had also had the J&J vaccine against Covid-19 within the prior two weeks. One of the six women died and one is in critical condition. The causation of these brain clots is not clear but the potential of them being related to the vaccination is worrisome enough to merit the recommendation of this pause. It should be pointed out that the J&J, as well as the AstraZeneca vaccines, have been “paused” due to concerns regarding blood clots. They both are based on a technology different than the messenger RNA technology used for the Pfizer and Moderna vaccines. 

The Advisory Committee on Immunization Practices (ACIP), which is a totally independent body, is meeting on April 14 in order to provide greater clarity regarding how to proceed with the J&J vaccine. The pause will allow time for directions or recommendations to doctors regarding treatment of these very rare clots, in light of the fact that the usual heparin treatment for blood clots has been deemed to be dangerous in these specific cases.  The pause will also allow for the reporting of yet to be documented cases and for the analyses of the epidemiology of all these cases of brain blood clots. The ACIP will be looking for what, if anything, the patients with these blood clots have in common. This pause will likely be on the order of days to a couple of weeks.  After the pause, new recommendations may result in restrictions on future Johnson & Johnson Covid-19 vaccination to certain age and gender groups. 

The good news about the status of vaccine administration in the United States is that the J&J vaccinations to date represent only 3% of the American vaccinations. The supply of Moderna and Pfizer will be sufficient to provide the USA’s needs without the J&J. In spite of the delays which will result from the pause of J&J we are still on track to be able to vaccinate every adult American by midsummer. In fact Pfizer just announced that they are 2 weeks ahead of the schedule for production of the vaccines already purchased by the US government.

We must follow the science and not bow to political pressure of certain governors who are complaining that the pause is an overreaction since there are only six cases and 7.2 million doses of the J&J administered.  Note that the number of women vaccinated in the age 18-48 age range is over a million. Thus the case occurrence rate in this demographic group is closer to 6 in a million. Putting this in context, we must consider that this age group has lost roughly 125 people per million to COVID-19. So safety first is indeed the consideration which must be followed.  Political expediency is not a reason to override medical safety. The processes in place to protect the public are working and should provide science based reassurance to the American people as we move forward in fighting this scourge.  Vaccine hesitancy remains a problem. Assuredly, this pause will fuel the skepticism of those already resistant and give pause to those on the fence.

Even if you have had the J&J vaccine within the last three weeks, you shouldn’t panic. Call your doctor or healthcare provider if you develop severe leg pains or headaches within 3 weeks of receiving your vaccination. Go to the emergency unit if your symptoms are particularly severe or you are unable to contact your doctor.

Our government is doing its part to keep us safe and provide us with the most current relevant information. Armed with truth and data we can make our own decisions. In the meantime, we must continue to do our part in this fight.  WEAR your mask, WASH your hands, WATCH your distance, and WAIT for your turn to get your vaccination.

 

Clyde E. Henderson, MD

Cincinnati Medical Association