The government has authorized the application of the Moderna vaccine for people over 12 years old – Telam

The national government on Tuesday formalized the authorization of the application of the Spikevak vaccine (mRNA-1273) against the coronavirus, developed by the Modern Laboratory, to people over 12 years old.

This was established by resolution 2711/2021, published in the Official Journal with the signature of the Minister of Health, Carla Vizzotti.

“The Spikevax vaccine (mRNA-1273), developed by Laboratorio ModernaTX Inc, under the provisions of articles 8 and 9 of law N 27.573 and in accordance with the recommendations of the ANMAT”, specifies the rule in its article 1.

The recitals indicate that The ANMAT “presented the documentation of the processing plants, as well as the list of countries and organizations that have authorized the product assessed as an emergency” and it is mentioned that the product is authorized, among others, by the United States, Canada, United Kingdom, Israel, European Union and the World Health Organization.

“The Department for the Evaluation and Control of Biological Products and Radio-farms (DECBR) carried out the evaluation of the information provided for the process of developing the active pharmaceutical ingredient (IFA), the finished product and the documentation. on validations and stability studies, resolving that, within the framework of the emergency authorization, it does not find any significant observations ”, specifies the resolution.

The standard also says that the Directorate for the Evaluation and Registration of Medicines “indicates that the results ofthe phase 3 efficacy analysis provided for the group over 18 years, showed that it is 94.1% to prevent symptomatic disease Covid-19 “ and that “the secondary efficacy for the prevention of serious diseases was 100% and in those over 65 years of age an efficacy of 86.4% was observed”.

“It is reported that this is a vaccine evaluated by the ANMAT, with a favorable result from the analysis of the documentation provided for the mRNA vaccine against Sars Cov-2 from the mRNA-1273 platform ( Lab. ModernaTX Inc.), and the parameters established for safety, immunogenicity and efficacy as acceptable for age groups over 12 years ”, concludes.