Temporary Ban On Johnson & Johnson Vaccine Lifted By FDA and CDC

CONNECTICUT — A brief pause in administration of the Janssen, or Johnson & Johnson, COVID-19 vaccine in the U.S. should be lifted and use of the vaccine should resume, according to a statement late Friday from the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC).

After six cases of a rare and severe type of blood clot following administration of the Janssen vaccine, medical and scientific teams studied data and recommended unique treatment for these blood clots and low platelets, also known as thrombosis-thrombocytopenia syndrome (TTS), according to a CDC report.

The FDA and CDC reported the following conclusions:

• 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.

Acting Connecticut Department of Public Health (DPH) Commissioner Dr. Deidre Gifford released this statement Saturday morning:

"With the announcement from the CDC and the FDA, we have advised our vaccine providers to start offering the J&J vaccine again. As the CDC and FDA noted, their enhanced review of this very rare blood clotting event found a total of 15 cases, all in women under the age of 60, out of more than 6.8 million doses of J&J administered. This pause and review will hopefully give people confidence that we take the safety of these vaccines very seriously and are committed to ensuring that that they meet the highest safety and effectiveness standards. Revised fact sheets for providers and patients have been issued by the FDA and give additional information about the benefits and risks of receiving the J and J vaccine. These will be made available prior to resuming vaccine administration.

"The CDC has determined that the known and potential benefits of the J&J vaccine outweigh the known and potential risks. That can be clearly seen here in Connecticut where our case and hospitalization rates and COVID deaths are declining as our vaccinations increase. It is clear that these vaccines are an effective tool in the fight against COVID-19, and we continue to urge all Connecticut residents over the age of 16 to get vaccinated when they can.

"With nearly a one in a million chance of developing this rare adverse reaction to the J&J vaccine and no evidence of similar issues with the other two vaccines, Pfizer and Moderna, you are far more likely to become ill or be hospitalized with severe COVID than you are from getting vaccinated. I strongly recommend that all eligible unvaccinated individuals get vaccinated as soon as they can. If you have concerns about the vaccines, please talk to your healthcare provider. We have vaccine providers throughout the state with open appointments ready to vaccinate anyone who wants a shot and makes the choice to take one more step toward a return to normalcy."

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