FDA and CDC recommend resuming use of Janssen COVID-19 vaccine

The US FDA and the Centers for Disease Control and Prevention (CDC) have decided that the pause on use of the Janssen (Johnson & Johnson) COVID-19 vaccine [Ad26.COV2-S] in the US should be lifted and use of the vaccine should resume. This announcement was made after a safety review was conducted and two meetings of the CDC Advisory Committee on Immunization Practices were held.

The pause was recommended after six cases of thrombosis, including intracranial sinus thrombosis, and thrombocytopenia were reported after administration of the Janssen COVID-19 vaccine. During the pause, all available data on the risk of thrombosis-thrombocytopenia syndrome (TTS) were reviewed, and teams at FDA and CDC conducted extensive outreach to providers and clinicians to ensure they were aware of the potential for these adverse events and could recognise and properly manage these events.

The FDA and CDC determined that they have confidence that the Janssen COVID-19 vaccine is safe and effective in preventing COVID-19, and that its benefits outweigh its known and potential risks in adults 18 years of age and older. Available data suggest that the risk of TTS is very low, but the FDA and CDC will continue to investigate this risk.

Vaccinators and people receiving the vaccine should review the Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine and the Fact Sheet for Recipients and Caregivers, respectively, which have been revised to include information about the risk of TTS.

"We identified exceptionally rare events – out of millions of doses of the Janssen COVID-19 administered – and we paused to examine them more carefully. As we always do, we will continue to watch all signals closely as more Americans are vaccinated," said CDC Director Dr Rochelle Walensky.