EMA begins rolling review of AstraZeneca COVID-19 vaccine
The EMA’s human medicines committee has initiated a rolling review of AstraZeneca’s COVID-19 vaccine candidate to test its efficacy.
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has started the first ‘rolling review’ of a COVID-19 vaccine, which is being developed by the company AstraZeneca in collaboration with the University of Oxford, UK.
The start of the rolling review means that the committee has started evaluating the first batch of data on the vaccine, which come from laboratory studies. The EMA says that this does not mean a conclusion can be reached yet on the vaccine’s safety and effectiveness, as much of the evidence is still to be submitted to the committee.
The rolling review is intended to speed up the assessment of a promising medicine or vaccine during a public health emergency. In the case of a rolling review, the CHMP reviews data as it becomes available from ongoing studies, before deciding that a formal application should be submitted.
The CHMP’s decision to start the rolling review of the vaccine is based on preliminary results from non-clinical and early clinical studies suggesting that the vaccine triggers the production of antibodies and T cells that target the virus.
The vaccine, called COVID-19 Vaccine AstraZeneca, is expected to work by preparing the body to defend itself against infection with the coronavirus SARS-CoV-2. This virus uses COVID-19 Spike (S) proteins, to enter the body’s cells and cause disease. COVID-19 Vaccine AstraZeneca is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making the SARS-CoV-2 S protein. The adenovirus itself cannot reproduce so does not cause disease. Once it has been administered, the vaccine delivers the SARS-CoV-2 gene into cells in the body. The cells will then use the gene to produce the S protein.
Large-scale clinical trials involving several thousands of people are ongoing and results will become available over the coming weeks and months. These results will provide information on how effective the vaccine is in protecting people against COVID-19 and will be assessed in later rolling review cycles. All the available data on the safety of the vaccine emerging from these studies, as well as data on its quality (such as its ingredients and the way it is produced), will also be reviewed.