FDA, CDC: Pause Johnson & Johnson Vax—What This Means for Immunocompromised Patients

Administration of the Johnson & Johnson COVID-19 vaccine has been paused following a few instances of blood clots within weeks of vaccination, according to a statement from federal agencies.

The Food & Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) issued a joint statement this morning that recommends “a pause in the use of this vaccine out of an abundance of caution.”

The New York Times reported today that there were six women who sustained blood clots. According to the FDA and CDC, all of the women were aged between 18 and 48 years, and the symptoms began within six to 13 days after receiving the one-shot vaccine.

The agencies recommended pausing the vaccine administration ahead of an Advisory Committee on Immunization Practices (ACIP) meeting scheduled for Wednesday.

“Right now, these adverse events appear to be extremely rare,” the statement notes.

The Janssen vaccine (J&J is the owner of Janssen Pharmaceuticals) is different from the Pfizer and Moderna vaccines in that it uses an adenovirus to help create the immune system’s response to the disease. The Pfizer and Moderna vaccines use messenger RNA (mRNA). The AstraZeneca vaccine (which is not approved for use in the United States) also uses an adenovirus.

Pfizer and Moderna’s vaccines both require two shots, administered several weeks apart.

The news about the Johnson & Johnson vaccine is still developing, and hopefully more answers will become available over the next several days and weeks.

(Notably, the National Psoriasis Foundation recently recommended that certain patients who receive the Johnson & Johnson vaccine take a two-week hiatus from methotrexate. Learn more here.)

So what about immunocompromised patients?

CreakyJoints issued the following on Twitter:

While we await answers, is it safe for patients with autoimmune diseases to receive one of the other two approved vaccines?

A previous study found that while about half of patients with autoimmune diseases are willing to get the COVID-19 vaccine, about a third remain uncertain about it—and with the latest news about the Johnson & Johnson vaccine, this hesitancy may even increase.

The Global Healthy Living Foundation (GLIF) said in a statement sent to DocWire News, “We believe that the actions taken by our federal agencies are an important reminder that the Vaccine Adverse Event Reporting System (VAERS) and other safety measures are working as intended. It is important to track and study potential adverse events, even when they are rare. GHLF encourages everyone to keep their vaccination appointments in accordance with public health recommendations and to speak with their health care provider if they have specific questions about their health history and vaccination.”

In December 2020, DocWire News interviewed Vinicius Domingues, MD, a rheumatologist in Daytona Beach, Fla., and medical advisor to CreakyJoints, to discuss what some of the top concerns have been among these patients as well as what information providers can give to these patients. At the time of the interview, the Pfizer vaccine had received emergency use authorization, and the Moderna approval was just days away.

According to Dr. Domingues, the most common question he heard from patients was whether or not they could get the disease from the vaccine—“and the answer is obviously not,” he said.

“The second most common question I see is, ‘Can I have [the vaccine], am I even going to be able to mount an immune response?’ And that gets a little bit more complicated,” he explained. “Depending on the medication you’re on, you’re not going to have as a robust of a response as you would if you didn’t. But at the end of the day, it is what it is. Some response is better than no response.”

Indeed, more recently, a small study found that patients with chronic inflammatory diseases—including rheumatoid arthritis, systemic lupus erythematosus, and more—who received an mRNA COVID-19 vaccine did develop antibodies.