The U.S. Food and Drug Administration (FDA) announced it had issued an emergency use authorization (EUA) for the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.
The FDA determined that the Janssen COVID-19 Vaccine has met the statutory criteria for issuance of a EUA.
The totality of the available data provides clear evidence that the Janssen COVID-19 Vaccine may effectively prevent COVID-19. The data also show that the vaccine’s known and potential benefits outweigh its known and potential risks, supporting the company’s request for the vaccine’s use in people 18 years of age and older. In making this determination, the FDA can assure the public and the medical community that it has conducted a thorough evaluation of the available safety, effectiveness, and manufacturing quality information.
This is the third EUA issued by the FDA for the prevention of COVID-19 caused by SARS-CoV-2.
“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,” stated Acting FDA Commissioner Janet Woodcock, M.D., in a related press release on February 27, 2021.
The Janssen COVID-19 Vaccine is manufactured using a specific type of adenovirus type 26 (Ad26). The vaccine uses Ad26 to deliver a piece of the DNA, or genetic material used to make the distinctive “spike” protein of the SARS-CoV-2 virus. While adenoviruses are a group of relatively common viruses, Ad26, which can cause cold symptoms and pink eye, has been modified for the vaccine to not replicate in the human body to cause illness.
After a person receives this vaccine, the body can temporarily make the spike protein, which does not cause disease but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.
“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,” added Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.
The EUA for the Janssen COVID-19 Vaccine was issued to Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson. The authorization will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics to prevent and treat COVID-19 is terminated. The EUA for Janssen COVID-19 Vaccine may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.
The FDA had previously issued EUA for the Pfizer-BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine.