EMA Starts ‘Rolling Review’ Of AstraZeneca’s COVID-19 Vaccine


EMA Starts ‘Rolling Review’ Of AstraZeneca’s COVID-19 Vaccine

In a statement, the EMA says the committee on medicines for human use “has started the first continuous review of a vaccine against covid-19, which is being developed by the company AstraZeneca in collaboration with the University of Oxford”.

“The start of the continuous review means that the committee has started evaluating the first batch of data on the vaccine, which comes from laboratory studies,” adds the EMA.

The decision comes after “preliminary results from initial non-clinical and clinical studies suggest that the vaccine triggers the production of antibodies and T cells”, that is, “cells of the immune system, the body’s natural defences”, against the virus.

“A continuous review is one of the regulatory instruments that the agency uses to speed up the evaluation of a promising drug or vaccine during a public health emergency,” says the EMA.

This moment does not mean, however, warns the EMA, “that a conclusion can still be reached on the safety and efficacy of the vaccine, since much of the evidence has yet to be presented to the committee”. “The continuous review will continue until sufficient evidence is available to support a formal application for marketing authorization,” concludes the EMA in the press release.

British pharmaceutical company AstraZeneca is developing a potential vaccine against the new coronavirus in conjunction with the University of Oxford, and is already in an advanced phase of large-scale clinical trials.

According to the results of the first results of clinical trials, released last July, this possible vaccine “looks safe and generates antibodies”, thus showing promising results with regard to safety and immunity.

The European Medicines Agency has also launched a similar process to endorse the use of remdesivir to cure Covid-19.