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The European Medicines Agency (EMA) began this Thursday the evaluation of the vaccine produced by the pharmaceutical AstraZeneca against covid-19, a process that comes after the preliminary results of clinical studies pointed to the production of antibodies.
In a statement, the EMA indicates that its committee on medicines for human use “initiated 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 European agency explains the decision that was made after “Preliminary results from initial clinical and non-clinical studies suggest that the vaccine triggers the production of antibodies and T cells”, that is to say, “cells of the immune system, the natural defenses of the organism”, against the virus.
“Continuous 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.
Even so, according to this entity, “this does not mean 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.”, concludes the EMA in the press release.
The EMA has triggered a similar process to support the use of the drug remdesivir to cure Covid-19.
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.
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