Pablo Sigal
12/30/2020 17:02
Clarín.com
Society
Updated 12/30/2020 17:02
Argentina is already in a position to apply the AstraZeneca vaccine against coronavirus, after the approval of the ANMAT, but at least
three months
will still have to pass
for the first doses to be available in Argentina, as announced by the national government: it would be between the end of March and the beginning of April.
In the meantime, the country would have at its disposal the new doses of the
Russian Sputnik V vaccine
that will arrive between January and February.
They are expected to be from both the first and second doses.
Today there is a stock equivalent to
10 million doses
of AstraZeneca vaccine, ready to be packaged.
As Clarín learned,
in mid-January
that volume of the active ingredient in the vaccine will be sent to Mexico to be packaged.
This production was made at the MAbxience plant in Garín, owned by the Sigman group.
There is the base of operations from which AstraZeneca plans to
supply all of Latin America with its vaccine
, except Brazil.
The approval of the vaccine by the Anmat could be finalized before the end of the year despite the fact that the phase 3 trial had
some methodological setbacks
and the AstraZeneca laboratory had to repeat a part of the experiment.
The problem arose when a group of volunteers had received two standard doses of the vaccine, with an efficacy of
62.1%
.
Due to an inconvenience attributed to an accident, another group received half a dose and then a full dose, with which the efficacy rose to
90%
.
Once in Mexico, the Liomont laboratory has to validate the batches and demonstrate safety and hygiene in the
fragmentation and filling stage
.
Then AstraZeneca will have to distribute the vaccines according to the commitments assumed in Latin America:
Argentina bought 22.4 million doses.
The mAbxience laboratory has a production capacity of approximately
25 million monthly doses
of the active
ingredient
.
And Mexico has a filling capacity of
23 million doses per month.
The agreement between AstraZeneca and mAbxience had been announced in August.
From that moment on, what is called
"technology transfer" began
, so that the Argentine laboratory was in a position to manufacture the Oxford vaccine.
After this stage, production itself began,
at the risk
that phase 3 of the trials could not pass international approvals.
Until now,
Great Britain and Argentina have already given them the go-ahead
and in this way production will continue.
This is the
third vaccine
that Argentina has approved in a period of just one week
.
The first was that of Pfizer that Anmat registered in the Argentine drug registry, in the emergency framework of the pandemic.
It was December 23rd.
A few hours later, the Ministry of Health authorized the Russian vaccine.
In that case, the Anmat only issued
a recommendation
for the Government to be empowered to use it.
Seven days later, the approval of the Oxford vaccine closed the end-of-the-year trilogy.
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