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

Following thorough safety reviews, examination of data to assess potential risks, and meetings conducted by the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and the CDC’s Advisory Committee on Immunization Practices, the FDA and CDC have determined that the recommended pause regarding the use of the Johnson & Johnson (J&J) COVID-19 vaccine across the United States should be lifted and administration resumed.  

The pause was drawn out of caution for the public, after six cases were reported of a severe type of blood clot after receiving the J&J vaccine. Symptoms transpired in the individuals 6 to 13 days after vaccination and “reports of adverse events following the use of the J&J vaccine suggest an increased risk of a rare adverse event called thrombosis with thrombocytopenia syndrome (TTS),” the CDC wrote in its updated guidance.

Health officials stated that the need to communicate proper treatment to doctors was an essential factor contributing to the FDA and CDC’s quick move to pause the J&J vaccination rollout across the country. During the pause, medical and scientific teams at the FDA and CDC examined data to assess potential risks of TTS and further administration of the vaccine. The teams also conducted extensive outreach to providers and clinicians to ensure they were made aware of the potential for these adverse events occurring and understood how to properly manage and recognize these events due to the unique treatment required for TTS.

After detailed analysis and research, the two agencies determined:

  • Use of the J&J COVID-19 vaccine should be resumed in the U.S.
  • This vaccine is safe and effective in preventing COVID-19.
  • The available data shows that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.
  • The available data suggests that the chance of TTS occurring is very low, however, the agencies will remain vigilant in continuing to investigate the risk.

While this adverse event is extremely rare, recipients of the J&J are recommended to monitor symptoms of blood clots, if any, for three weeks after receiving the vaccine. Keep in mind, there are other COVID-19 vaccines options currently available — Pfizer-BioNTech vaccine and Moderna vaccine.

Healthcare providers administering the vaccine are encouraged to review the J&J COVID-19 Vaccine Fact Sheet for Healthcare Providers, and vaccine recipients and caregivers should review the Fact Sheet for Recipients and Caregivers. These fact sheets have been revised to include important information regarding what the J&J vaccine is, what to expect, who should receive the vaccine, preparation and administration and details on the TTS syndrome.

As distribution of the J&J vaccine continues, individuals are encouraged to seek out valuable guidance on COVID-19 vaccine availability and distribution from federal, state and local health officials. Click here for additional information.

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