Irene Hartmann
12/24/2020 10:00
Clarín.com
Society
Updated 12/24/2020 10:05 AM
It is less than two pages long and is addressed to Dr. Arnaldo Medina, head of the Secretariat for Quality in Health of the Ministry of Health of the Nation.
Clarín
accessed the famous report through which the ANMAT recommended to the portfolio led by Ginés González García to authorize the Russian Sputnik V vaccine against the coronavirus.
The key phrase is at the end: it says that since “
the known and potential benefits for the health of the population are greater than the uncertainty
that may exist, this National Administration recommends to the Minister of Health of the Nation to advance in the Emergency Authorization, taking into account that the vaccine referenced in this report ”.
It is a very brief text, entitled "Technical report on the regulatory profile on the authorization of the use of Sputnik V vaccine within the framework of law 27,573" and, on the one hand, it highlights that, "this National Administration has received the corresponding information (...) in relation to the compliance of the manufacturing plants, the development and the production of the products, as well as their certification in the country of origin and compliance with quality standards.
At the same time, the information available in the preliminary cut shows safety and efficacy in a higher than acceptable range, as well as indicates that there have been no serious adverse events,
no lack or less effectiveness in the different age groups for which it is currently indicated ”.
Regarding the
ages
of those who could receive the vaccine, the text remarks that “although the data provided and the analyzes carried out by the owner of the product indicate the use of the vaccine in
an age range of 18 to 60 years
, this type of authorizations receives sequential information input and a new preliminary cut will be made whose resolution of the analysis may extend its indication of use to other age groups than those initially established ”.
Sputnik V vaccine loading in Moscow / Presidency
In addition, it explains that within the framework of the visit to the plants of the Russian company, after "carrying out technical verification of the establishments and the manufacturing processes used in the products" (between December 14 and 18), it was concluded that "they are
acceptable and compatible with the provisions of current regulations in the Argentine Republic
.
"
News in development
Look also
Coronavirus: why the ANMAT approved the Pfizer vaccine and the Russian Government
Vaccination against the coronavirus in Argentina: the 5 keys of the manual that doctors received