02/09/2021 8:36 AM
Clarín.com
Society
Updated 02/09/2021 8:54 AM
The Ministry of Health issued a resolution by which it approved, on an emergency basis, the coronavirus vaccine produced by the Serum Institute of India.
The Covishield / ChAdOx1nCoV-19 Corona Virus Vaccine-Recombinant vaccine "is the result of the development of the production process carried out by the Serum Institute of India in collaboration with the University of Oxford and AstraZeneca in the context of a technology transfer", highlighted resolution 627 / 2021, published this Tuesday in the Official Gazette.
From Health they argue that the transfer
"does not impact on quality, safety and efficacy"
already evaluated by the Anmat when it approved the specialty developed by the University of Oxford and AstraZeneca.
"By virtue of this precedent, the evaluation of the documentation received has as its scope the quality aspects and the exercise of comparability inherent in the development of the production process in the context of technology transfer between Serum Institute of India and University of Oxford-Astra Zeneca , in order to determine that said transfer does not impact on the quality, safety and efficacy already evaluated by this Administration, "the resolution maintains.
The process was similar to that followed when the use of the Russian Sputnik V vaccine was approved on an emergency basis, before the phase 3 studies were published in the peer-reviewed journal The Lancet.
A woman receives her first dose of a COVID-19 vaccine inside the vaccination center at Shatabdi Hospital in Mumbai, India.
Photo Xinhua.
"
There have been
no
serious adverse events
, nor have significant differences been identified in the efficacy observed in the different age groups that participated in clinical trials," says the resolution signed by Minister Ginés González García.
The vaccine produced by the Serum Institute has already been approved by twelve health authorities from different countries, in addition to its place of origin in India.
The resolution also establishes that the
National Commission for Vaccine Safety
will continue with its "surveillance system" to "detect the events allegedly attributed to vaccines and immunizations (ESAVI) and carry out a correct analysis and classification of them, in order to be able to have a tool that guarantees the safety of the vaccines used and allows their adequate surveillance ".
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