FDA grants emergency use authorization to Janssen COVID-19 vaccine

The US Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) for the Janssen COVID-19 Vaccine, Ad26.COV2.S, developed by Johnson & Johnson‘s subsidiary, Janssen Biotech. This marks the third vaccine authorized by the FDA to combat COVID-19, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Details of the Authorization:

The EUA allows the Janssen COVID-19 Vaccine to be distributed and administered within the United States to individuals 18 years of age and older. Acting FDA Commissioner Janet Woodcock highlighted the significance of this authorization, stating, “The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States.”

Vaccine Technology and Efficacy:

The Janssen vaccine utilizes a viral vector approach, using adenovirus type 26 (Ad26) to deliver a piece of DNA that codes for the SARS-CoV-2 virus spike protein. This modified virus is engineered to be replication-deficient, meaning it cannot cause illness in vaccinated individuals. Instead, it prompts an immune response that prepares the body to defend against the coronavirus.

Safety and Effectiveness:

The FDA asserts that the available data indicates that the Janssen COVID-19 Vaccine’s known and potential benefits outweigh its known and potential risks. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, affirmed, “After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for the authorization of a vaccine for emergency use.”

Future Projections and Commitments:

In August 2020, Janssen Pharmaceutical committed to producing and supplying 100 million doses of the Ad26.COV2.S vaccine to the US government in a deal valued at over $1 billion. This agreement underscores the scale of response aimed at curbing the pandemic.

With this new authorization, the Janssen COVID-19 Vaccine joins the arsenal of vaccines available to combat the pandemic in the United States, offering a single-dose option that may facilitate wider and faster distribution and administration.