FDA, CDC greenlight resumption of Johnson & Johnson COVID-19 vaccine use

Following a recommended pause due to rare cases of severe blood clots among those administered the Janssen (Johnson & Johnson) COVID-19 vaccine, the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) are encouraging use to continue.

The announcement followed a thorough safety review of the vaccine, which determined that the vaccine is both safe and effective, and its potential benefits outweigh its known and potential risks. In particular, the chance of thrombosis-thrombocytopenia syndrome (TTS) — the blood clotting concern — occurring in recipients of the Janssen vaccine remains very low.

To date, cases of TTS have occurred in 15 individuals following administration of the Janssen COVID-19 vaccine, out of more than 6.8 million people given the shot. All occurred in women between the ages of 18 and 59 years old. Despite the low figures, the two agencies recommended that health care providers administering the vaccine and vaccine recipients be made aware of the risks of TTS.

“Safety is our top priority,” Acting FDA Commissioner Janet Woodcock said. “This pause was an example of our extensive safety monitoring working as they were designed to work—identifying even these small number of cases. We’ve lifted the pause based on the FDA and CDC’s review of all available data and in consultation with medical experts and based on recommendations from the CDC’s Advisory Committee on Immunization Practices.”

That advisory committee will continue monitoring the vaccine’s use and any further information on TTS. Its findings so far were based on reports submitted to the Vaccine Adverse Event Reporting System (VAERS), as well as medical literature and information from other global regulators detailing reports of thrombosis with thrombocytopenia that emerged during the use of a similar COVID-19 vaccine.

“Above all else, health and safety are at the forefront of our decisions,” CDC Director Rochelle Walensky said. “Our vaccine safety systems are working. 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.”