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meIn a statement, the EMA indicates that its committee on medicines for human use “initiated the first continuous review of a vaccine against COVID-19-19, which is being developed by the company AstraZeneca in collaboration with the University of Oxford “.
“The initiation of ongoing review means that the committee has begun evaluating the first batch of data on the vaccine, which comes from laboratory studies.“adds the EMA.
The European agency explains that the decision was made after “preliminary results of the initial clinical and non-clinical studies suggested that the vaccine triggers the production of antibodies and T cells”, that is, “cells of the system”. immune, the body’s natural defenses “against the virus.
“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.
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,” the EMA concludes in the press release.
EMA started a similar process to support the use of the drug remdesivir to heal the COVID-19-19.
The pharmaceutical company britasingle 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 in July In the past, this potential vaccine “appears safe and generates antibodies,” thus showing promising results in terms of safety and immunity.
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