How to talk to patients about the J&J vaccine
Patients will be coming to pharmacists with questions and concerns as the recommendation to pause use of the Janssen (Johnson & Johnson, J&J) vaccine remains in place.
After it was reported that six female patients in the United States developed life-threatening blood clots since receiving the J&J COVID-19 vaccine, CDC and FDA recommended pausing use of the vaccine.
APhA spoke with Stephan Foster, PharmD, FAPhA, APhA liaison to CDC’s Advisory Committee on Immunization Practices (ACIP), to get his thoughts on talking to patients about the J&J vaccine with the information we have so far.
The conversation has been edited for clarity.
What is the extent of the risk of the J&J vaccine right now with what we know?
SF: What we know is that there were six cases in the United States of patients with cerebral venous sinus thrombosis (CVST) with thrombocytopenia. CVST is rare in itself, but when you combine it with thrombocytopenia, it’s even more rare.
We have also been presented with data from Europe on the AstraZeneca vaccine, which is a similar platform-type vaccine to the J&J vaccine. There have been quite a few cases of CVST and additional cases of different types of thrombosis within the body along with thrombocytopenia from the AstraZeneca vaccine. The question seems to be more about the vaccine platform than the coronavirus antigen component.
What should people who recently got the J&J vaccine know?
SF: I would tell patients that this is extremely rare—six cases when you’ve administered 6 to 7 million doses of the vaccine, to put it in perspective.
If you’ve already received the J&J vaccine and don’t have symptoms, I would not worry about it.
However, pharmacists should be aware of symptoms of blood clots in patients if they are experiencing them, and the patient should be referred for evaluation.
Heparin should be avoided as a treatment.
The six cases we know about only occurred in women, in the age group of 18–48 years, and symptoms occurred within 2 weeks. There was one male in the Phase 3 trial for the J&J vaccine who experienced this, so it may not just be women. They are looking at other risk factors, too. Out of the six cases, there was not one common risk factor in all of them.
How should pharmacists who have been providing the J&J vaccine respond to patients’ concerns?
SF: I would stress that our safety net on vaccines is incredible if you can pick up six cases out of 6 million doses. The monitoring system is working.
If we have this review system to detect this type of thing, patients should be assured that safety is one of the most important issues here. It’s pretty incredible that we actually caught it.
The pause was put on this to evaluate and see if the blood clots were actually caused by the vaccine or not. We have not determined yet if the vaccine is the cause of the problem.
The six cases were all identified through the Vaccine Adverse Event Reporting System (VAERS), further emphasizing the importance of reporting adverse events to VAERS and having patients sign up for V-safe.
How can pharmacists talk to patients who may refuse the J&J vaccine going forward? What might help them overcome their reservations?
SF: We have two other vaccines we can refer them to. Acknowledge their concerns and provide them with the available information and options related to authorized vaccines.
How can pharmacists put the pause in perspective?
SF: The ACIP committee did not want to make a recommendation for or against the vaccine until they had more data. Over the next two weeks they will be collecting as much data as they can find on this and will regroup.
Reported symptoms in the patients occurred 6 to 13 days after vaccine administration. Right now, the data that we analyzed on these six cases have been collected on about half of the doses of the J&J vaccine that have been given. The other half of the doses of the vaccine given have not had that roughly 2-week window for patients to develop adverse effects. FDA wanted to pause the J&J vaccine to see if more of these cases pop up.
What are the safety concerns right now around storage and distribution of the J&J vaccine?
SF: The only advice is to follow recommended storage and handling procedures, including keeping the unpunctured vaccine vials refrigerated with a safety sticker on it saying: “Do not use.” We need to wait a couple weeks to see what happens.