As per the notification published on 5 May 2022, the Food and Drug Administration (FDA) has amended the Emergency Use Authorization (EUA) and restricted the use of Janssen COVID-19 vaccine to:

People (age 18 years and above) for whom other approved SARS-CoV-2 vaccines are not clinically suitable or approachable

People (age 18 years and above) who choose to obtain Janssen vaccine because they would else not get a coronavirus vaccine

Following the conduction of updated assessment, the FDA decided that the risk of thrombosis with thrombocytopenia syndrome (TTS), a condition of fatal blood clots along with low levels of blood platelets with the onset of symptoms about 1-2 weeks after usage of Janssen vaccine warrants restricting vaccine use.

On 27 February 2021, the Janssen vaccine was granted approval for emergency usage. On 13 April 2021, the US-FDA and Centers for Disease Control and Prevention (CDC) declared a pause in vaccine usage to evaluate 6 reported cases of TTS, and to make sure that the healthcare workers are cognizant of TSS and can plan for correct treatment. On 23 April 2021, the recommended pause concerning the utilization of the Janssen COVID-19 vaccine was raised by CDC, Advisory Committee on Immunization Practices, and FDA.

Overall, 15 TTS cases were reported to Vaccine Adverse Event Reporting System (VAERS) that included the first 6 cases from around 8 million doses. After evaluating updated safety and efficacy data of the vaccine, the Advisory Committee on Immunization Practices suggested to use mRNA COVID-19 vaccines over Janssen vaccine in people 18 years and older in December 2021.

In an updated assessment of TTS cases after the use of the Janssen vaccine that was reported to VAERS through 18 March 2022, the FDA and CDC detected 60 confirmed cases, including 9 fatal cases. As per FDA, the reporting rates of TTS deaths is 0.48 per million doses of vaccine given while the reporting rates of TTS is 3.23 per million doses of vaccine given. For limiting the approved usage of Janssen Vaccine, the agency considered that reporting rates of TTS and TTS mortality post-vaccination are not lower when compared to the previous report.

Additionally, the factors that put a person at TTS risk after Janssen Vaccine use remain uncertain. According to FDA, people having TTS might rapidly worsen, in spite of prompt diagnosis and management. Furthermore, TTS has an elevated mortality rate and can elicit long-term and devastating health consequences.

Examples of people who might still receive Janssen Vaccine include: (i) People who witness an anaphylactic reaction after use of mRNA coronavirus vaccine, (ii) People who would remain unvaccinated for coronavirus due to restricted access to mRNA coronavirus vaccines, and (iii) People exhibiting personal concerns with receiving mRNA vaccines and would otherwise not get SARS-CoV-2 vaccine.