On April 13, The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) recommended pausing the use of Johnson and Johnson’s Janssen vaccine out of an abundance of caution after reports of blood clotting in 6 individuals who recently received the vaccine.
After a thorough review, the CDC and FDA on April 23 recommended lifting the pause, stating they had confidence that the vaccine was safe and effective in preventing COVID-19.
While NACo is closely monitoring these announcements in an effort to put forth timely and relevant information for members, please see below for answers from federal officials to commonly asked questions regarding these announcements.
Why was the paused announced?
The FDA & CDC has recommended a pause (not a stop) of J&J vaccinations based solely on the below:
- Due to the rare nature of the clotting condition, it is important that doctors and healthcare professionals know what signs and symptoms to look out for. This particular clotting condition cannot be treated with the standard procedures for blood clotting, and requires special medical procedures to treat or otherwise it can be fatal. The pause gave the FDA and CDC time to aggressively provide outreach to healthcare providers on how they can diagnose, treat, and report this rare condition.
- The pause gave the scientific and medical community more time to assess correlation of the clotting condition to the Johnson and Johnson vaccine or predisposing conditions of those impacted. So in other words, is this a direct result of the vaccination or do these individuals have other illnesses and conditions that contribute to their likelihood of developing blood clots?
- The pause allowed a panel of CDC advisors to make new or modified recommendations on who should get the vaccine, if necessary based on further investigation.
WHY WAS THE PAUSED LIFTED?
After a thorough review, the CDC and FDA stated they had confidence the vaccine was safe and effective. In addition, the agencies added:
The chance of experiencing this type of blood clotting (thrombosis-thrombocytopenia syndrome) was very low, but the FDA and CDC would continue to investigate the risk. The vaccine’s benefits outweigh its risks in individuals 18 years of age and older.Women younger than 50 years old should be aware of the rare but increased risk of this adverse event and the other COVID-19 vaccine options available to them. Fact sheets for healthcare providers and patients regarding the vaccine had been updated with additional information about the risk of this syndrome.
What should messaging be for those individuals who have already received the Johnson and Johnson vaccine?
The CDC and FDA have determined the vaccine is safe, and the occurrence of these blood clots following the J&J vaccination are extremely rare. Following an extensive review, the CDC reported it found a total of a total of 15 reported cases and three deaths out of the approximately 8 million doses of Johnson and Johnson vaccine administered in the United States.. All of these cases occurred in women, and 13 of the cases occurred in women between the ages of 18-48.
FDA officials are encouraging people who received J&J in last couple weeks to monitor symptoms of blood clotting, which include severe headaches, abdominal pain, leg pain, and/or shortness of breath. These symptoms differ from typical symptoms people generally have after being vaccinated, which include (but are not limited to) pain the arm where the shot was administered, fatigue, and fever.
Officials from both CDC and FDA emphasized that people who have received a vaccine from either Pfizer or Moderna, or have received a Johnson and Johnson vaccine more than three weeks ago should not be concerned. No clotting incidences with thrombocytopenia have been identified in the more than 220 million people combined that have received the Pfizer or Moderna vaccines. Those individuals who are experiencing symptoms of blood clotting after being vaccinated by the Johnson and Johnson vaccine should contact their medical provider and disclose that they were recently vaccinated.
What Is the Federal Government Advising Local Distribution Sites to Do with Johnson and Johnson Vaccine Doses?
The CDC recommends continuing to store the J&J vaccine in a refrigerator between 36°F and 46°F, which some counties are already doing because of the pause. Additionally, the CDC recommends determining if the expiration date has been extended by scanning the QR code before disposing of the vaccine.
What some of the key messages county officials can deliver to their constituents to increase vaccine confidence?
The CDC has emphasized the vaccines continue to undergo the most intensive safety monitoring in U.S. history. FDA scientists emphasize the pause and review should give Americans confidence that the proper systems are working.
The CDC has also reiterated there have been no reported cases of blood clotting related to the Pfizer and Moderna vaccines, and the risk of developing a blood clot as a result of the J&J vaccine remains extremely low.