This week, the Food & Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) recommended a pause in administration of the Johnson & Johnson COVID-19 vaccine following a few instances of blood clots within weeks of vaccination, according to a joint statement.
So far, there have been reported cases of the rare blood clots in six people—all women—aged between 18 and 48 years, and they occurred within six to 13 days of receiving the one-shot vaccine, according to the FDA and CDC. Overall, about 7 million people in the United States have received the Johnson & Johnson vaccine.
Some experts fear this will adversely impact the vaccine rollout in the United States. The Johnson & Johnson vaccine accounts for very few of the vaccines that have been administered, and the United States is still primed to reach its vaccination goal even if only the shots from Pfizer and Moderna are used. However, one concern is that the latest news will increase vaccine hesitancy overall.
The news is of significance for immunocompromised patients, who are at a greater risk of COVID-19. In December the CDC issued guidance regarding messenger RNA (mRNA) COVID-19 vaccines in patients with underlying medical conditions. According to the CDC, “mRNA COVID-19 vaccines may be administered to people with underlying medical conditions provided they have not had a severe allergic reaction to any of the ingredients in the vaccine.” (The Pfizer and Moderna vaccines use mRNA technology, unlike the Johnson & Johnson vaccine. At the time of this guidance, only Pfizer and Moderna were authorized for emergency use.)
Michael C. Schweitz, MD, a rheumatologist with Arthritis and Rheumatology Associates of Palm Beach and a medical advisor to CreakyJoints, told DocWire News in an interview that he believes it’s important for patients with rheumatic disease to be vaccinated due to the significant risk that COVID-19 poses.
“I’m still recommending that patients get either Moderna or the Pfizer vaccine. As far as the J&J vaccine goes, I think the pause is a good idea to really get into the details of the significant problem, although we’re talking about 1 in a million. So these thrombotic events are so far are very limited, very rare, but serious,” he said.
Vinicius Domingues, MD, a rheumatologist in Daytona Beach, Fla., and medical advisor to CreakyJoints, said that he does not believe the latest news means immunocompromised patients shouldn’t get the Johnson & Johnson vaccine.
“Yes, the incidence of issues appear to be very low,” he said. “However, the FDA panel will meet again and decide on the J&J vaccine faith.”
Dr. Domingues said he is still fielding questions from his patients every day, and remains “confident with the safety and efficacy.”
“The rate of clots appear to be 1 in 1 million which is definitely very low. As long as the patient is comfortable, he/she should move forward,” he explained.
Dr. Schweitz, who is also a longtime volunteer rheumatologist with the John Whelton Arthur Virshup CreakyJoints South Florida Arthritis Clinic, past president of the Coalition of State Rheumatology Organizations (CSRO), and past president of the Florida Society of Rheumatology, has not received as many questions from patients, as many of them have already been vaccinated, but he addressed what information doctors should be giving their patients who may have received the J&J shot already.
“If the patient received it three or four weeks ago, the chances of having a problem that could be related to it are relatively small. It’s tiny anyway,” he said. “If the patient just received the vaccine, then you have to tell them things to be aware of. If you have swelling in your leg, pain in your calf, or you have headaches, you have to talk to your doctor about having that looked at.”
Dr. Domingues recommends that doctors treating patients with rheumatic disease “inform their patients with more recent available data. I do believe the CDC and FDA will issue guidance very soon. This is a developing story still,” he noted.
Similarly, Dr. Schweitz said that the publicity surrounding the vaccines is bringing a lot of awareness to the medical community, which is a good thing. Rare events are more difficult to identify in clinical trials with 30,000 to 40,000 people than in a real-world setting, where millions of people are receiving the treatment, he said.
“So the signal has been raised, and I think the medical community has to be more aware to watch for this, to see if there are more cases that we’re not aware of,” Dr. Schweitz said.