European Medicines Agency EMA has Launched Third Rolling Review of a COVID-19 Vaccine Candidate for Europe

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The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has started the third rolling review process, the evaluation of successive data submissions to speed up the marketing authorisation procedure, for a vaccine against COVID-19 for Europe.

The vaccine is Ad26.COV2.S, a COVID-19 vaccine from Janssen-Cilag International N.V.

The entire evaluation process of the European Medicines Agency (EMA) until a medicinal product is authorised for the European market usually takes much longer than one year. During this process, the safety, quality and efficacy of a vaccine are checked. Now, a third COVID-19 vaccine candidate is undergoing the rolling review process, which is designed to speed up the process of getting a COVID-19 vaccine candidate authorised. For example, the evaluation of pharmaceutical and non-clinical development data packages can be started before the full clinical data for the formal marketing authorisation application are available.

The decision of the Committee for Medicinal Products for Human Use (CHMP) to start the ongoing review of Ad26.COV2.S is based on preliminary results of laboratory studies and early clinical trials in adults. These studies suggest that the vaccine triggers the production of antibodies and immune cells directed against the SARS CoV2 corona virus.

The company is currently conducting human studies to assess safety, immunogenicity (how well the vaccine triggers a response against the virus) and efficacy. As soon as the data from these and other clinical trials become available, the CHMP’s scientific experts at the EMA will evaluate them. The continuous review will continue until sufficient data are available to formally apply for marketing authorisation.

Background and effectiveness of Ad26.COV2.S

Like other vaccines, Ad26.COV2.S is designed to prepare the body to defend itself against infection. Ad26.COV2.S is a vector vaccine: an adenovirus (harmless cold virus) contains genetic instructions for a protein called spike protein (S), which is present on the surface of the SARS CoV2 corona virus. When a person is given this vaccine, their cells read the genetic instructions and produce the spike protein.

The immune system will then treat this protein as foreign and produce natural defences – antibodies and T cells – against it. When the vaccinated person later comes into contact with SARS-CoV-2, the immune system recognises the virus and is ready to attack it. The antibodies and immune cells can work together to kill the virus and prevent it from entering the body cells. Infected cells can also be destroyed. All this can help protect against COVID-19.

  • Paul Ehrlich Institut photo ElleAon/