FDA limits use of the J&J Janssen COVID-19 vaccine

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The U.S. Food and Drug Administration has limited the use of the Johnson & Johnson Janssen COVID-19 vaccine due to rare blood-clotting instances of thrombosis with thrombocytopenia syndrome (TTS) after receiving the vaccine.

TTS is a syndrome in which an individual develops blood clots in the veins or arteries, in addition to low platelet counts. Symptoms occur one to two weeks following vaccine administration. The FDA said it has determined that the risk of TTS warrants limiting the authorized use of the vaccine.

The FDA and Centers for Disease Control and Prevention have identified 60 confirmed cases of TTS, including nine deaths, following administration of the Janssen COVID-19 vaccine. The data is from cases reported to the Vaccine Adverse Event Reporting System through March 18.

The reporting rate of TTS is 3.23 per million doses of vaccine administered, and the reporting rate of TTS deaths is 0.48 per million doses of vaccine administered.

The FDA is limiting the Janssen vaccine to individuals 18 and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 vaccine because they would otherwise not receive a vaccine.

Examples of individuals who may still receive the Janssen COVID-19 vaccine include those who experienced an anaphylactic reaction after receipt of an mRNA COVID-19 vaccine, those concerned about receiving mRNA vaccines and individuals who would remain unvaccinated due to limited access to mRNA COVID-19 vaccines.

The FDA has determined that the known and potential benefits of the vaccine for the prevention of COVID-19 outweigh the known and potential risks. In making the determination to limit the authorized use of the vaccine, the agency considered that reporting rates of TTS and TTS deaths following administration are not appreciably lower than previously reported. Furthermore, the factors that put an individual at risk for TTS following administration of Janssen COVID-19 vaccine remain unknown.

The FDA also said it considered that individuals with TTS may rapidly deteriorate, despite prompt diagnosis and treatment; that TTS can lead to long-term and debilitating health consequences; and that TTS has a high death rate. The agency also considered the availability of alternative authorized and approved COVID-19 vaccines that provide protection from COVID-19 and have not been shown to present a risk for TTS.

WHY THIS MATTERS

The FDA is telling healthcare providers to instruct vaccine recipients to seek immediate medical attention for shortness of breath, chest pain, leg swelling, persistent abdominal pain, neurological symptoms (including severe or persistent headaches or blurred vision) or petechiae spots beyond the site of vaccination. 

The clinical course of TTS shares features with autoimmune heparin-induced thrombocytopenia. In individuals with suspected TTS, the use of heparin may be harmful and alternative treatments may be needed. 

THE LARGER TREND

In February 2021, Janssen Biotech, a pharmaceutical company of Johnson & Johnson, received emergency use authorization for its COVID-19 vaccine as a single primary vaccination dose for individuals 18 years of age and older and as a single booster dose for individuals 18 years of age and older at least two months after completing primary vaccination.

On April 13, 2021, the FDA and the CDC announced a recommended pause in administration of the vaccine to investigate six reported cases of TTS, and to help ensure that healthcare providers were made aware of the potential for TTS in order to plan for proper recognition and management due to the unique treatment required.  

On April 23, 2021, following a safety evaluation, including two meetings of the CDC's Advisory Committee on Immunization Practices, the FDA and CDC lifted the recommended pause. The agencies confirmed a total of 15 cases of TTS had been reported to the Vaccine Adverse Event Reporting System, including the original six reported cases, out of approximately eight million doses administered. 

In December 2021, after reviewing updated vaccine effectiveness and safety data, the CDC's Advisory Committee on Immunization Practices made a preferential recommendation for the use of mRNA COVID-19 vaccines over the Janssen COVID-19 vaccine in all persons 18 years of age and older in the United States.

The rare TTS blood clots have also been linked to AstraZeneca's COVID-19 vaccine, according to the European Medicines Agency safety committee, the Pharmacovigilance Risk Assessment Committee. The AstraZeneca vaccine is not authorized for use in the United States. In March 2021, countries in Europe and elsewhere put a pause on the vaccine after a handful of people – mostly women younger than 60 – developed TTS, according to Yale Medicine.

ON THE RECORD

"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," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. "Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals."

Twitter: @SusanJMorse
Email the writer: SMorse@himss.org