FDA makes Janssen vaccines available

▪ The FDA has permitted two batches of Janssen (Johnson & Johnson) Covid-19 vaccine made in the Emergent BioSolutions Baltimore plant to be used under emergency use authorization (EUA).

▪ The FDA stated, “The FDA’s decision to include these two batches of vaccine drug substance in the EUA for the Janssen COVID-19 vaccine means that Janssen vaccine made with this drug substance can be used in the US or exported to other countries.”

▪ The FDA has found that “several other batches are not suitable for use, but additional batches are still under review, and the agency will keep the public informed as those reviews are completed.”

▪ The FDA has extended the expiration date for Janssen vaccine stored at 2-8 degrees Celsius from 3 months to 4.5 months.

▪ The European Medicines Agency (EMA) has recommended not releasing batches of vaccines containing the active substance produced at about the same time that the contamination occurred.