EMA’s human medicines committee (CHMP) has started a rolling review of NVX-CoV2373, a COVID‑19 vaccine being developed by Novavax CZ AS (a subsidiary of Novavax, Inc.).

The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and early clinical studies in adults. These studies suggest that the vaccine triggers the production of antibodies and immune cells that target SARS-CoV-2, the virus that causes COVID‑19.

The company is currently conducting trials in people to assess its safety, immunogenicity (how well it triggers a response against the virus) and its effectiveness against COVID-19. 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.

EMA will assess the vaccine’s compliance with the usual standards for effectiveness, safety and pharmaceutical quality. While EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review.

How is the vaccine expected to work?

Like other vaccines, NVX-CoV2373 is expected to prepare the body to defend itself against infection. The vaccine is a protein-based vaccine which contains tiny particles made from a laboratory-grown version of the spike (S) protein found on the surface of SARS-CoV-2 coronavirus. It also contains an ‘adjuvant’, a substance to help strengthen the immune responses to the vaccine.

When a person is given the vaccine, their immune system will identify the protein particles as foreign and produce natural defences — antibodies and T cells — against them. If later on, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognise the spike protein on the virus and be prepared to attack it. The antibodies and immune cells can protect against COVID-19 by working together to kill the virus, prevent its entry into the body’s cells and destroy infected cells.

Posted on the EMA website on 3 February 2021