The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have determined that the use of the Janssen COVID-19 vaccine should resume for individuals 18 years of age and older after a thorough safety review.

On April 13, 2021, a pause in use was recommended following 6 reported cases of cerebral venous sinus thrombosis (CVST) that occurred in combination with thrombosis-thrombocytopenia syndrome (TTS) among women 18 to 48 years of age. During the pause, the FDA and CDC assessed the potential risk of CVST in combination with TTS based on reports submitted to the Vaccine Adverse Event Reporting System (VAERS), as well as the available medical literature and information provided from global regulatory partners related to a similar COVID-19 vaccine that contains a replication-incompetent adenoviral vector. 

As of April 23, 2021, a total of 15 cases of TTS have been reported to VAERS, including the original 6 reported cases. All of these cases occurred in women between the ages of 18 and 59, with a median age of 37 years. Individuals who have received the Janssen COVID-19 vaccine should contact their healthcare provider immediately if they develop severe headache, chest pain, shortness of breath, leg swelling, severe abdominal pain, petechiae or excessive bruising within 2 weeks after vaccination.


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“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,” said Janet Woodcock, MD, Acting FDA Commissioner. “We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality.”

Monitoring of vaccine safety using established surveillance systems will continue and any new reports of TTS will be investigated, according to the Agencies. In the meantime, healthcare providers are advised to report vaccine-related adverse events to the Vaccine Adverse Event Reporting System.

References

  1. FDA and CDC lift recommended pause on Johnson & Johnson (Janssen) COVID-19 vaccine use following thorough safety review. [press release]. Silver Spring, MD: US Food and Drug Administration; April 23, 2021. 
  2. Johnson & Johnson single-shot COVID-19 vaccinations to resume in the U.S. for all adults aged 18 and older following CDC and FDA decision. [press release]. New Brunswick, NJ: Johnson & Johnson; April 23, 2021.

This article originally appeared on MPR