Janssen COVID-19 Vaccine No Longer Authorized for Emergency Use

The Food and Drug Administration (FDA) has revoked the Emergency Use Authorization (EUA) of the Janssen COVID-19 Vaccine.

According to Janssen, the last lots of the vaccine purchased by the US government have expired. As there is no demand for the vaccine in the US, the Company will not be updating the strain composition to address emerging variants.

The Janssen COVID-19 Vaccine was issued an EUA in February 2021. Following reports of an increased risk of thrombosis with thrombocytopenia syndrome, the FDA and the Centers for Disease Control and Prevention (CDC) recommended a temporary pause on the use of the vaccine.

In May 2022, the FDA limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines were not accessible or clinically appropriate; and for those who elect to receive the Janssen COVID-19 vaccine because they otherwise would not receive a COVID-19 vaccine.

In May 2023, Janssen Biotech sent a letter to the FDA requesting that the EUA for the vaccine be withdrawn. To protect the public, the FDA subsequently revoked the authorization.

The FDA has approved 2 mRNA COVID-19 vaccines: Comirnaty (Pfizer-BioNTech) and Spikevax (Moderna). The Pfizer-BioNTech and Moderna COVID-19 Vaccines are also authorized for emergency use for certain patient populations. The Novavax COVID-19 Vaccine, a protein-based vaccine, received emergency authorization in July 2022.