By Special to the AFRO
The Emergency Use Authorization (EUA) of the Janssen COVID-19 vaccine, put on the market by Johnson & Johnson, was revised by the U.S. Food and Drug Administration (FDA) this month.
The revised authorization limits its use to individuals aged 18 or older for whom other approved COVID-19 vaccines are unavailable or medically inappropriate and to those aged 18 or older who opt to receive the Janssen COVID-19 vaccine because they would be otherwise unable to get vaccinated.
The FDA determined the risk of developing thrombosis with thrombocytopenia syndrome (TTS), with symptoms appearing approximately one to two weeks after receiving the Janssen
COVID-19 vaccine.
TTS is a rare and newly identified syndrome reported in people who have received adenoviral vector COVID-19 vaccines such as AstraZeneca and the Janssen vaccine by Johnson & Johnson. This syndrome is characterized by the formation of blood clots with low blood platelet counts.
This determination was made after an updated evaluation and investigation of reported cases of TTS. The results of the updated analysis and investigation warranted the limitation of the authorized use of the Janssen COVID-19 vaccine by the FDA.
The known and potential benefits of the vaccine were determined by the FDA to outweigh the known and potential risks for anyone aged 18 and older who elects to receive the Janssen vaccine because other available vaccines are not medically appropriate and/or not available.
The revision of the authorized use of the Janssen COVID-19 vaccine is currently reflected in the Fact Sheet for Healthcare Providers Administering Vaccine. A warning statement is included at the beginning of the fact sheet for immediate notice and transparency and summarizes the TTS risks. It also advises of TTS symptoms and instructs anyone exhibiting symptoms to seek immediate medical attention.
The Janssen COVID-19 vaccine was authorized for emergency use on Feb. 27, 2021. The FDA and Centers for Disease Control and Prevention (CDC) recommended a pause in the administration of the vaccine after six reported TTS cases. The pause was announced on April 13, 2021, to allow for investigation of the six reported cases and to ensure health care providers were made aware of the potential risk of developing TTS after vaccine administration. It also allowed for proper recognition, planning, and management of the unique required treatment for TTS.
The FDA lifted the pause on April 23, 2021, following a thorough safety evaluation, including two meetings of the CDC’s Advisory Committee on Immunization Practices (ACIP). The FDA and CDC confirmed that 15 total cases of TTS were reported to the Vaccine Adverse Event Reporting System (VAERS), including the original six cases. These 15 reported cases of TTS were out of approximately 8 million administered doses of the vaccine.
These data and the deliberations and recommendations by the ACIP were able to help the FDA assess the known and potential benefits of the Janssen COVID-19 vaccine for persons aged 18 and older. The data suggested the possibility of developing TTS was remote, but the investigations into the heightened potential risk due to vaccination and specific risk factors continued. It was at this point the Fact Sheet for Health Care Providers Administering vaccine was revised to include information about the risk of blood clots in combination with low blood platelets after receiving the Janssen COVID- 19 vaccine.
In December 2021, the ACIP made a preferential recommendation for the use of mRNA COVID-19 vaccines over the Janssen COVID-19 vaccine in all persons aged 18 years and older in the United States. The ACIP recommendation and CDC endorsement were to consider the Janssen vaccine in the following situations:
- When a contraindication to receipt of the mRNA COVID-19 vaccine is present.
- When a person would remain unvaccinated for COVID-19 due to limited access to mRNA vaccines.
- When, despite the identified safety concerns, a person opts to receive the Janssen vaccine.
All suspected cases of TTS reported to VAERS have been continuously monitored and investigated by the FDA and CDC. An updated analysis of TTS cases following receipt of the Janssen COVID-19 vaccine reported to VAERS through March 18, 2022, confirmed 60 cases of TTS, including nine fatalities. The FDA determined the reporting rate of TTS is 3.23 per million vaccine doses administered, and the reported TTS death rate is 0.48 per million administered doses.
The determination to limit the authorized use of the Janssen COVID-19 vaccine by the FDA considered that the reported rates of developing TTS and TTS deaths after administration of the vaccine are not appreciably lower than previously reported. Also taken into consideration is that factors that put an individual at risk for developing TTS after receiving the Janssen COVID-19 vaccination remain unknown. The agency also considered the possibility that despite prompt diagnosis and treatment, TTS can lead to rapid deterioration, long-term catastrophic health consequences, and that there is a high death rate for TTS.
Individuals who may still receive the Janssen COVID-19 vaccine include those who suffered an anaphylactic reaction after administration of an mRNA COVID-19 vaccine, individuals with personal objections or concerns about mRNA vaccines who would remain otherwise unvaccinated against COVID-19, and those who would remain unvaccinated due to limited availability of mRNA COVID-19 vaccines.
The safety of COVID-19 vaccines approved and authorized for emergency use are vigorously monitored by the FDA’s passive and active safety and surveillance system, in collaboration with the CDC, the Centers for Medicare and Medicaid Services, the Department of Veterans Affairs and other healthcare data systems (both academic and large government).
“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. 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…We’ve been closely monitoring the Janssen COVID-19 vaccine and the occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA,” said Peter Marks, M.D., PhD., director of the FDA’s Center for Biologics Evaluation and Research. “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 evaluate new safety information.”
The revised EUA for the Janssen COVID-19 vaccine was issued to Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson.
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