Use of the J&J/Janssen vaccine is resuming for those ages 18 and older in New Jersey after the FDA and CDC reviewed safety considerations related to reports of blood clots. After the extensive review, the FDA and CDC announced confidence in the vaccine.

• The FDA has determined that a review of the data shows that the vaccine’s benefits outweigh its risks.
• At this time, the available data suggest that the chance of blood clots is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk.

The FDA has issued updated fact sheets for both  providers administering the vaccine as well as patients. The FDA also issued an amended Emergency Use Authorization for the vaccine.  The NJDOH provided a directive late Friday (attached) about the resumption of the vaccine’s use in New Jersey this week.

“This process should demonstrate for the public that the federal vaccine safety monitoring system is strong and should instill confidence in receiving any of the three approved vaccines,” said Health Commissioner Judy Perschilli.