Following careful review and deliberation, FDA is taking important steps that will allow a critically needed supply of the Janssen (Johnson & Johnson) COVID-19 Vaccine to be made available.
On June 11, 2021, FDA announced that it is authorizing for use, under the Emergency Use Authorization (EUA) for the Janssen COVID-19 vaccine, two batches of vaccine drug substance manufactured at the Emergent BioSolutions facility in Baltimore. Before making this decision, the FDA conducted a thorough review of facility records and the results of quality testing performed by the manufacturer. Based on this review and considering the current COVID-19 public health emergency, the FDA concluded these batches are suitable for use. While the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to work through issues there with Janssen and Emergent BioSolutions management.
Additionally, the FDA has extended the expiration dating for the refrigerated Janssen COVID-19 Vaccine after reviewing information submitted by Janssen and determining that the vaccine can be stored at 2-8 degrees Celsius for 4.5 months instead of 3 months. Health care providers may check the expiration date by lot number at the company’s website: https://vaxcheck.jnj/ .