Pablo Sigal
12/23/2020 17:07
Clarín.com
Society
Updated 12/23/2020 5:38 PM
"The whims are fulfilled,"
a national government source
tells
Clarín
, a little jokingly, a little seriously, to celebrate that finally the
Russian vaccine Sputnik V
against the coronavirus will be able to be applied before the end of the year in Argentina, just as President Alberto Fernández promised.
That will be once the Aerolineas Argentinas plane returns this Thursday from Russia with
the first 300 thousand doses
.
Added to this acquisition logistics was a timed and
unorthodox
administrative work
.
The
differences
between coronavirus vaccines are not only in their components, but also in the way they are enabled for use.
That happened this time from a law passed in early November,
tailored to the Russian vaccine.
In the case of Pfizer or AstraZeneca, these are private laboratories that submit the request for
approval or registration
to Anmat.
The Argentine watchdog is the exclusive protagonist: it analyzes the results obtained in clinical trials and decides whether to approve, reject or request more information.
In the case of the Russian Sputnik V vaccine, although at the beginning of the negotiation there was a local laboratory that acted as an intermediary, it was later removed from the environment by the Government, which decided to negotiate
from State to State.
And take power away from the Anmat.
The Argentine State is not an entity regulated by ANMAT.
This means that although it is the one who
buys and imports
the vaccine, the procedure is not included in
provision 705 of the year 2005
, which is the framework that regulates the approval of all the medicinal specialties in the country.
In other words, in the case of the Russian vaccine,
it is not and will not be registered as a medicine in Argentina
.
It was authorized by the Government in an emergency, after a recommendation made by Anmat, which was
one more link
in a chain of decisions.
This was possible after Congress approved
Law 27,573
, published in the official gazette on November 6, precisely so that the Government had the power to authorize the Russian vaccine in
"the exceptionality of the pandemic context."
In this scenario, what the Anmat does is
recommend authorization
, but it does not approve or register.
According to officials from the Argentine control body, "the procedure for analyzing the vaccine information does not change."
However, beyond the work of the Anmat, there are
two
key
elements
that are usually present in the approval of drugs.
Especially in medicines of relevance such as the vaccine against a pandemic that has already killed more than
1.7 million people in the world and more than 42 thousand in Argentina
.
And in this case, for now, they are not: one is the support of other international agencies, such as the US FDA or the European EMA.
The other, scientific publications.
“Each agency in the world is independent,” they cut themselves off from Anmat and added: “The fact that a drug is approved in the United States or Europe does not mean that it will automatically be approved in Argentina.
There may be different criteria ”.
As for the fact that the information on the vaccine is not yet published in The Lancet (something that the Russian laboratory Gamaleya announced that it would do), the official response is that "the information is held by Anmat, which is an
internationally recognized agency
" .
Resolution 2,284 of the Ministry of Health, known this Wednesday, details which are the
seven agencies
that participated in the authorization of the vaccine: the National Immunization Commission, the National Commission for Vaccine Safety, the Federal Health Council, the National Control Directorate of Non-communicable Diseases, the Undersecretariat of Health Strategies and the Secretariat of Access to Health, in addition to the Anmat.
"The data are not published and that is a shit", said to be graphic a recognized infectologist when asked about the authorization granted by the Government to the Russian vaccine.
And he explained that while the approval of Sputnik is good news, the fact that it has
not
yet
been approved for people over 60
adds a share of uncertainty.
From Anmat they explained that when Russia approves its vaccine for that age group, the papers will
have to return to the
Argentine
control agency
for analysis, and from there it will be decided whether it also recommends its use in that population.
In Argentina there are
215,000 doctors and 179,000 nurses
, so the first 300,000 doses will not be enough to immunize everyone.
But it is imperative that licensing for those over 60 ceases to be a promise when the first batch of 5 million vaccines arrives, announced for January.
$
Look also
Russia wants Sputnik V to be manufactured in Argentina in the second quarter of 2021
Coronavirus in Argentina: the Ministry of Health authorized the use of the Russian vaccine Sputnik V