For immediate release:

Today, the United States Food and Drug Administration limited the licensed use of the Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other licensed or approved COVID-19 vaccines are not clinically or accessible. appropriate, and to persons 18 years of age. age and older who choose to receive the Janssen COVID-19 vaccine because they would not otherwise receive a COVID-19 vaccine.

Key points:

  • After conducting an updated analysis, evaluation, and investigation of reported cases, the FDA has determined that the risk of thrombosis with thrombocytopenia syndrome (TTS), a syndrome of rare and life-threatening blood clots in combination with low levels of platelets with the onset of symptoms approximately one to two weeks after administration of the Janssen COVID-19 vaccine, justifies limiting the authorized use of the vaccine.
  • 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 for persons 18 years of age and older for whom other licensed or approved COVID-19 vaccines are not available. not accessible or clinically appropriate, and for people 18 years of age and older who choose to receive the Janssen COVID-19 vaccine because they would not otherwise receive a COVID-19 vaccine.
  • The information sheet for health care providers administering the vaccine now reflects the revised authorized use of the Janssen COVID-19 vaccine and includes a disclaimer at the beginning of the information sheet for prominence that summarizes information on the risk of TTS. In addition, information on the revised authorized use of the vaccine and updated information on this risk of blood clots with low levels of blood platelets have been added to the information sheet for recipients and carers.

“We recognize that the Janssen COVID-19 vaccine continues to play a role in the current pandemic response in the United States and in the global community. Our action reflects our updated analysis of the risk of TTS after administration of this vaccine and limits the use of the vaccine to certain individuals,” said Peter Marks, MD, Ph.D., director of the Center for Biologics Evaluation and Research at the FDA. “Today’s action demonstrates the robustness of our safety oversight systems and our commitment to ensuring that science and data guide our decisions. We closely monitored the Janssen COVID-19 vaccine and the occurrence of TTTS following its administration and used updated information from our safety monitoring systems to revise the EUA. The agency will continue to monitor the safety of the Janssen COVID-19 vaccine and all other vaccines, and as has been the case throughout the pandemic, will thoroughly assess new safety information.

Background

The Janssen COVID-19 vaccine was authorized for emergency use on February 27, 2021. On April 13, 2021, the FDA and the Centers for Disease Control and Prevention (CDC) announced a recommended pause in administration of the vaccine for to investigate six reported cases of TTTS, and to ensure healthcare providers were aware of the potential for TTTS and could plan for appropriate recognition and management due to the unique treatment required for TTTS.
On April 23, 2021, following an extensive safety assessment, including two meetings of the CDC’s Advisory Committee on Immunization Practices (ACIP), the FDA and CDC lifted the recommended pause on the use of the Janssen COVID-19 vaccine. The agencies confirmed that a total of 15 cases of TTS had been reported to the Vaccine Adverse Event Reporting System (VAERS), including the six cases initially reported, out of approximately 8 million doses administered.

These data, along with ACIP’s deliberations and recommendations, contributed to the FDA’s assessment that the known and potential benefits of the Janssen COVID-19 vaccine outweighed its known and potential risks in people with 18 and over. The available data suggest that the risk of TTTS occurring was low, but investigation of the level of potential excess risk due to vaccination and specific risk factors continued. At that time, the information sheet for healthcare providers administering a vaccine was revised to include a warning about the risk of TTS and the information sheet for beneficiaries and caregivers was also revised to include information about blood clots in combination with a low blood platelet count after receiving the Janssen covid19 vaccine.

In December 2021, after reviewing updated vaccine efficacy and safety data, ACIP issued a preferential recommendation for the use of COVID-19 mRNA vaccines over the Janssen COVID-19 vaccine. among all persons 18 years of age and older in the United States. ACIP has recommended and CDC has approved that the Janssen COVID-19 vaccine may be considered in certain situations: when a person has a contraindication to receiving COVID-19 mRNA vaccines, when a person would otherwise remain unvaccinated against COVID-19 due to limited access to mRNA COVID-19 vaccines, and when a person wishes to receive the Janssen COVID-19 vaccine despite identified safety concerns.

Actual status

The FDA and CDC have continuously monitored and investigated all suspected cases of TTS reported to VAERS. In an updated analysis of cases of TTS following administration of the Janssen COVID-19 vaccine that were reported to VAERS through March 18, 2022, the FDA and CDC identified 60 confirmed cases, including nine fatal cases. The FDA has determined that the notification rate for TTS is 3.23 per million doses of vaccine administered and the death notification rate for TTS is 0.48 per million doses of vaccine administered.

In making the decision to limit the licensed use of the Janssen COVID-19 vaccine, the agency considered that the rates of reporting TTS and death from TTS after administration of the Janssen COVID-19 vaccine are not materially lower than those reported previously. Additionally, the factors that put an individual at risk for TTS following administration of the Janssen COVID-19 vaccine remain unknown. The FDA also considered that people with TTS can deteriorate rapidly, despite prompt diagnosis and treatment, that TTS can lead to long-term and debilitating health consequences, and that TTS has a high mortality rate. The agency also reviewed the availability of other licensed and approved COVID-19 vaccines that provide protection against COVID-19 and have not been shown to pose a risk of TTS.

The following are examples of people who may receive the Janssen COVID-19 vaccine: people who have experienced an anaphylactic reaction after receiving an mRNA COVID-19 vaccine, people who have personal concerns about receiving mRNA vaccines and who would otherwise not receive a COVID-19 vaccine and people who remain unvaccinated against COVID-19 due to limited access to COVID-19 mRNA vaccines.

Continuous security monitoring

The FDA has established a robust safety oversight system to monitor the safety of COVID-19 vaccines approved and cleared for emergency use. The FDA monitors the safety of COVID-19 vaccines through passive and active safety monitoring systems in collaboration with the CDC, Centers for Medicare and Medicaid Services, Department of Veterans Affairs, and other health data systems academic and non-governmental.

The revised EUA for the Janssen COVID-19 vaccine has been issued to Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson.

Related information

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Master key

The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.