[ad_1]
In a statement, the EMA assures that the committee for medicines for human use “has begun 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 beginning of the continuous review means that the committee has begun to evaluate the first batch of data on the vaccine, which comes from laboratory studies,” adds the EMA.
The decision comes after “preliminary results of initial clinical and non-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 defenses,” against the virus. .
Antenna 1
“An ongoing review is one of the regulatory tools the agency uses to expedite the evaluation of a promising drug or vaccine during a public health emergency,” says the EMA.
This moment does not mean, however, the EMA warns, “that a conclusion can still be reached on the safety and efficacy of the vaccine, since much of the evidence has not yet been presented to the committee.” “Ongoing review will continue until sufficient evidence is available to support a formal application for marketing authorization,” the EMA concludes in the press release.
The British pharmaceutical company AstraZeneca is developing a possible vaccine against the new coronavirus together 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, published last July, this possible vaccine “appears safe and generates antibodies”, thus showing promising results in terms of safety and immunity.
The European Medicines Agency has also launched a similar process to support the use of remdesivir to cure Covid-19.
