EMA begins rolling reviews for a COVID-19 therapeutic and a vaccine
The European Medicines Agency (EMA) has initiated a rolling reviews of Vero Cell, an inactivated COVID-19 vaccine, and sotrovimab, a monoclonal antibody.
The European Medicines Agency (EMA) uses rolling reviews to speed up the assessment of a promising medicine during a public health emergency, such as the COVID-19 pandemic. Under the typical application process for marketing authorisation, all data on a medicine or vaccine’s effectiveness, safety and quality, as well as all required documents must be ready at the start of the evaluation. In the case of a rolling review, EMA’s Committee for Medicinal Products for Human Use (CHMP) reviews data as they become available from ongoing studies. Once it decides that sufficient data are available, the company can submit a formal application. This shortens the approval timeframe.
The EMA announced that it has begun a rolling review of Sinovac Life Sciences Co. Ltd’s COVID-19 Vaccine (Vero Cell) Inactivated.
The review was started after preliminary results suggested the vaccine triggers the production of antibodies that target SARS-CoV-2, the virus that causes COVID-19, and may help protect against the disease. Currently the CHMP is reviewing pre-clinical and early clinical data and will evaluate further results as they become available.
Through the evaluation, the EMA will assess the compliance of Vero Cell with the usual EU standards for effectiveness, safety and quality and decide whether the benefits of Vero Cell outweigh the risks. The rolling review will continue until enough evidence is available for a formal marketing authorisation application.
While the exact timeframe for the CHMP to evaluate an eventual marketing authorisation application, it should be shorter than normal because of the work done during the rolling review.
The CHMP has also initiated a rolling review of data on sotrovimab (also known as VIR-7831 or GSK4182136), a monoclonal antibody developed by GlaxoSmithKline and Vir Biotechnology Inc. for the treatment of COVID-19.
The decision to begin the review was based on preliminary results from an ongoing study looking at the ability of the medicine to prevent hospitalisation or death in non-hospitalised patients with COVID-19. However, EMA has not yet received the full dataset and it is too early to draw any conclusions regarding the benefit-risk balance of the medicine.
The CHMP is currently evaluating the first batch of data, which comes from laboratory and animal studies, in addition to data on the quality of the medicine. The review of data as a it becomes available will continue, as above, until enough evidence is available to support a formal marketing authorisation application.
Sotrovimab is a monoclonal antibody with activity against COVID-19. It is designed to attach to the Spike (S) protein of SARS-CoV-2 virus, limiting its ability to infect host cells through the S protein interacting with the human angiotensin-converting enzyme 2 (ACE2) receptor. This is expected to prevent severe symptoms and thus reduce the need for hospitalisation in patients with COVID-19.