Government clears emergency use of Indian vaccine – News

This was after being approved in the last few hours by the National Administration of Drugs, Food and Medical Technologies (ANMAT).

By resolution 627/2021, published this Tuesday in the Official Journal with the signature of the Minister of Health, Ginés González García, the vaccine against the coronavirus produced by the Serum Institute of India has been authorized urgently.

“The vaccine against the Corona Covishield / ChAdOx1nCoV-19 virus – recombinant vaccine produced by the Serum Institute of India is authorized under Articles 8 and 9 of Law No. 27,573 and in accordance with the recommendations of the ANMAT”, is emphasized in the Official Journal.

The vaccine, named Covishield / ChAdOx1nCoV-19 Corona Virus Vaccine – Recombinant, is the result of a technology transfer agreement between the Serum Institute of India, the University of Oxford and the AstraZeneca laboratory.

The Official Journal underlines that the ANMAT has received all the information and remarks according to which the new vaccine approved in its test phase “did not present serious adverse events, nor significant differences in efficacy observed in the different sections. of age participating in clinical trials. “

The Secretariat for Health Quality and the Secretariat for Access to Health, both of the Nation, accepted “this measure within the framework of their competence”.

The Ministry of Health estimated that this transfer “has no impact on the quality, safety and efficacy” already evaluated by the ANMAT when the specialty developed by the University of Oxford and AstraZeneca.

To carry out its emergency use, the ANMAT “had all the information as established by the emergency authorization procedure, with regard to compliance with the standards required of processing plants, development and manufacture. products, its certification in the country of origin and compliance with quality standards “.

The vaccine produced by the Serum Institute has already been approved by twelve health authorities in different countries, in addition to India.