FDA and CDC Lift Pause on J&J COVID-19 Vaccine

The US Food and Drug Administration and the US Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Janssen (Johnson & Johnson) COVID-19 Vaccine in the US should be lifted and use of the vaccine should resume.

The new recommendation was issued today following a “thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices.”

The pause was recommended two weeks ago after reports of six cases of a rare and severe type of blood clot in individuals following administration of the Janssen COVID-19 Vaccine out of more than 6.8 million J&J doses administered.

During the pause, medical and scientific teams at the FDA and CDC examined available data to assess the risk of thrombosis involving the cerebral venous sinuses, or CVST (large blood vessels in the brain), and other sites in the body (including but not limited to the large blood vessels of the abdomen and the veins of the legs) along with thrombocytopenia, or low blood platelet counts.

Today, the agencies confirmed that a total of 15 cases of TTS have been reported to VAERS, including the original six reported cases. All of these cases occurred in women between the ages of 18 and 59, with a median age of 37 years. Reports indicated symptom onset between 6 and 15 days after vaccination.

The teams at FDA and CDC also conducted outreach to providers and clinicians to ensure they were made aware of the potential for these adverse events and could properly manage and recognize these events due to the unique treatment required for these blood clots and low platelets, also known as thrombosis-thrombocytopenia syndrome.

The two agencies have determined the following:

• Use of the Janssen COVID-19 Vaccine should be resumed in the United States.
• The FDA and CDC have confidence that this vaccine is safe and effective in preventing COVID-19.
• The FDA has determined that the available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.
• At this time, the available data suggest that the chance of TTS occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk.
• Health care providers administering the vaccine and vaccine recipients or caregivers should review the  Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers)external icon and Fact Sheet for Recipients and Caregiversexternal icon, which have been revised to include information about the risk of this syndrome, which has occurred in a very small number of people who have received the Janssen COVID-19 Vaccine.

Reports of adverse events following vaccination can be made to the Vaccine Adverse Event Reporting Systemexternal icon.