FDA approves the Janssen COVID-19 Vaccine for emergency use

The US Food and Drug Administration (FDA) has granted Janssen’s single-shot COVID-19 vaccine Emergency Use Authorization (EUA). This is the third vaccine to receive such approval in the US and it allows the Janssen COVID-19 Vaccine to be distributed for use in individuals 18 years of age and older.

The FDA has determined that the Janssen COVID-19 Vaccine has met the statutory criteria for issuance of an EUA; ie, the totality of the available data provides clear evidence that the Janssen COVID-19 Vaccine may be effective in preventing COVID-19. The data also show that the vaccine’s known and potential benefits outweigh its known and potential risks in people 18 years of age and older. According to the agency, in making this determination, it conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.

The Janssen COVID-19 Vaccine uses adenovirus type 26 (Ad26) as a vector to deliver a piece of DNA encoding the SARS-CoV-2 virus’ Spike (S) protein. The viral vector cannot cause disease, instead it delivers the genetic code to cells and causes the body to temporarily make the S protein, triggering an immune response against SARS-CoV-2, the virus that causes COVID-19.

The EUA was granted because an analysis of 39,321 participants enrolled in an ongoing randomised, placebo-controlled study revealed that the vaccine was approximately 67 percent effective at preventing moderate to severe/critical COVID-19 occurring at least 14 days after vaccination and 66 percent effective in preventing moderate to severe/critical COVID-19 occurring at least 28 days after vaccination. In the trial, 19,630 received the vaccine and 19,691 received saline placebo.

Additionally, the analysis suggested the vaccine was approximately 77 percent effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85 percent effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination. It also completely prevented death as a result of COVID-19.

At this time, data are not available to determine how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person. 

For the EUA, the agency also reviewed available safety data from 43,783 of the study participants. In the 21,895 participants who received the vaccine, the most common side effects were pain at the injection site, headache, fatigue, muscle aches and nausea. Most of these side effects were mild to moderate in severity and lasted one or two days. Each participant was followed for at least eight weeks after vaccination.

Under the EUA, it is mandatory for Janssen Biotech Inc. and vaccination providers to report the following to the Vaccine Adverse Event Reporting System (VAERS) for Janssen COVID-19 Vaccine: serious adverse events, cases of Multisystem Inflammatory Syndrome and cases of COVID-19 that result in hospitalisation or death. 

It is also mandatory for vaccination providers to report all vaccine administration errors to VAERS and for Janssen Biotech Inc. to include a summary and analysis of these in monthly safety reports submitted to the FDA.

The FDA highlighted that an EUA is not an approval of the vaccine, it simply allows the use of unapproved medical products in an emergency to diagnose, treat or prevent a condition, such as COVID-19, when there are no adequate, approved and available alternatives. 

The EUA for the Janssen COVID-19 Vaccine was issued to Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson. The authorisation will be effective until it is deemed that the circumstances which justified the authorisation of the emergency are no longer evident. Additionally, the EUA for the Janssen COVID-19 Vaccine may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.