FDA Scales Back Use of Johnson & Johnson COVID Vaccine

The Food and Drug Administration (FDA) on Thursday scaled back the use of the Johnson & Johnson COVID-19 vaccine, citing concerns about the risk of rare but life-threatening blood clots.

Now, the vaccine is only authorized for two groups of people:

• People 18 and over for whom Pfizer and Moderna COVID-19 vaccines are not accessible or clinically appropriate
• People 18 and over who choose Johnson & Johnson because they would otherwise not receive a COVID-19 vaccine

The decision comes after an an FDA investigation of thrombosis with thrombocytopenia syndrome (TTS), a blood clotting condition. TTS is treatable, but complications can include heart attack and stroke. At least 60 J&J vaccine recipients have experienced TTS. Nine have died.

Around 18.7 million Americans have received the J&J vaccine.

"We recognize that the Janssen COVID-19 Vaccine still has a role in the current pandemic response in the United States and across the global community," Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement, a nod to the fact that J&J's vaccine is simpler to store and transport than mRNA vaccines. "Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions."

The FDA officially revised the J&J vaccine fact sheet, indicating that anyone with a history of TTS following COVID vaccination should not receive this vaccine as a booster.

Not the First Setback for J&J

The new authorization echoes earlier guidance from the Centers for Disease Control and Prevention (CDC), who officially recommended the Pfizer and Moderna COVID-19 vaccines over the J&J shot in December 2021. At the time, CDC advisers cited 54 documented cases of TTS linked to the J&J vaccine.

In April of 2021, federal regulators temporarily paused the use of the J&J vaccine following six cases of cerebral venous sinus thrombosis (CVST), a type of blood clot in the brain.

The pause was lifted and a warning label was added to the vaccine. 

In July of 2021, the FDA added another warning label to the J&J vaccine for its potential to trigger an autoimmune disorder called Guillain-Barré Syndrome (GBS). At the time, about 100 cases had been reported. GBS can lead to full body-paralysis, though most people make a full recovery. 

What If You Received a J&J Vaccine?

If you received a J&J shot, you shouldn’t panic. Remember: The risk of experiencing this side effect is very low. According to CDC data, only 3.83 TTS cases were reported for every million doses of the J&J vaccine administered. 

The CDC advisory panel also reported that the median time from vaccination to symptom onset was nine days, with the longest record being 18 days after vaccination. If you’re two or three weeks past the date of your vaccination, you’re likely in the clear.

What Symptoms Should You Look For?

According to the CDC, symptoms of TTS can manifest itself in several ways:

• Pain and swelling in an extremity
• Chest pain
• Numbness or weakness on one side of the body
• Sudden change in mental status

If you experience any of the above symptoms within three weeks of receiving a COVID-19 vaccine, contact a healthcare provider.

How Is TTS Treated?

TTS treatment is different from that of standard blood clot. The low levels of blood platelets associated with this condition mean that anticoagulation medication like Heparin could worsen the condition.

Other blood thinners, like bivalirudin or argatroban, can be used instead. Bivalirudin was used to successfully treat a Colorado woman experiencing TTS in April of last year.

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.