EMA begins rolling review of Janssen’s COVID-19 vaccine candidate

The European Medicines Agency’s (EMA) human medicines committee (CHMP) has initiated a rolling review of Ad26.COV2.S, a COVID-19 vaccine produced by Johnson & Johnson’s (J&J) pharmaceutical division, Janssen. 

According to the EMA, the CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies and early clinical studies in adults. These studies suggest that the vaccine triggers the production of antibodies and immune cells that target the SARS-CoV-2 coronavirus, which is causing the COVID-19 pandemic.

Ad26.COV2.S is expected to prepare the body to defend itself against infection. The vaccine contains genetic instructions for a protein known as Spike (S) protein which is present on the surface of SARS-CoV-2 coronavirus. When a person is given the vaccine, their cells will read the genetic instructions and produce the S protein. The person’s immune system will then treat this protein as foreign and produce antibodies and T cells against it. If the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognise the virus and be prepared to attack it. The antibodies and immune cells can work together to kill the virus, prevent its entry into the body’s cells and destroy cells that are infected, thus helping to protect against COVID-19.

The company is currently conducting trials in people to assess safety and immunogenicity and effectiveness and will assess the vaccine’s compliance with the usual standards for effectiveness, safety and quality. The EMA will evaluate data from these and other clinical trials as they become available. The rolling review will continue until enough evidence is available for a formal marketing authorisation application, the regulatory body says.

While EMA does not predict the overall timelines, it suggests that it should take less time than normal to evaluate an eventual application because of the work done during the rolling review.