Vanesa Lopez
11/02/2020 4:24 PM
Clarín.com
Society
Updated 11/02/2020 4:24 PM
The Secretary of Access to Health of the Nation, Carla Vizzotti, traveled to Russia to negotiate the purchase of the vaccine to prevent the coronavirus, called Sputnik V. Although it was reported that the Government would think to have it before the end of the year, references consulted by
Clarín
point out that it is not yet known when it will be approved.
The vaccine is based on adenovirus vectors, like the one from AstraZeneca and the Chinese one from CanSino.
Although it has one characteristic that distinguishes it: it
uses two different adenoviruses -
one for the first dose and one for the second dose - with the speculation that this would increase the immune response.
Spokesmen for the Russian Direct Investment Fund (RDIF) - which finances the production of this vaccine - explain that it does not contain live human adenoviruses, but rather uses human adenoviral "vectors" that cannot reproduce "and are completely safe for health", they assure.
In addition, it does not contain the SARS-CoV-2 virus, "which
makes it impossible to contract Covid-19
as a result of vaccination," they point out from the RDIF.
Mass vaccination in Russia is scheduled to begin between November and December.
Photo Reuters.
Russian sources add that phase 1 and 2 clinical trials have already been completed.
"As published in
The Lancet
, (the vaccine) elicited a stable cellular and humoral immune response in 100% of participants in phase 1 and 2 clinical trials," they comment.
However, for the infectologist Eduardo López, presidential advisor on issues related to Covid-19, "
it could not be shown that it is effective
."
“So far it has only one publication, in
The Lancet
, from September of this year.
The study could not show that the vaccine is effective in preventing Covid-19 because it has a very low number of patients, only 72.
It is a small study
, ”says López.
In addition, the infectologist continues, the study has a short follow-up period of just 42 days.
It was not checked against placebo, but it is an open study.
And, surprisingly, it did not incorporate the female sex.
“These limitations, which are important for a phase 1 and 2, are recognized by the authors of the work.
Therefore, the efficacy in large masses of the population
cannot be demonstrated,
”López continues.
The Sputnik V vaccine was approved for limited use in Russia.
It is used to protect doctors and paramedics exposed to Covid-19.
Photo Reuters.
It is currently in phase 3 clinical trials, which includes more than 40,000 volunteers, both from Russia, India, the United Arab Emirates, and Belarus, among other countries.
Talks began in Brazil last week.
Sputnik V's head of clinical research, Nikita Lomakin, explained to the Russian newspaper Izvestia that
people with cancer, who receive cancer drugs or immunosuppressive therapy, patients with viral hepatitis, who had an acute myocardial infarction or a stroke
are excluded from the study.
acute over the course of a year, and patients with allergic reactions.
"This is not a minor issue," says López, and differentiates it from clinical trials for other vaccines, in which patients at risk are included.
For his part,
Carlos Luna
, former president and Coordinator of the Respiratory Infections Section of the Argentine Association of Respiratory Medicine (AAMR), believes that "
it is no more promising than other
available
vaccines
."
And remember that there are currently more than 200 projects, and that 40 of them are in phases 1, 2 or 3.
“It has not been shown to be different from other vaccines under trial.
In fact, so far the results of most are similar in terms of safety and efficacy.
It will be necessary to see in phases 3 and 4 if there are differences ”, concludes Luna.
When would it be available in Argentina?
RDIF spokespersons explain that the vaccine was approved for
limited use
in Russia and is now used to protect front-line doctors and paramedics exposed to Covid-19.
"Mass vaccination in Russia is scheduled to begin in November-December," they anticipate.
Is it possible that it will be available in Argentina during 2020?
"
I consider it very unlikely,
" replied López, since "it is a vaccine that is in an early stage of analysis for phase 3".
"With the available data, it is not a vaccine that today could be universally applied in any country in the world", synthesizes the infectologist.
And he adds: "Clinical studies can be done in many countries, but it seems to me that it
is too early
to approve it for massive use."
The Sputnik V vaccine is based on adenovirus vectors.
Photo Reuters.
Sputnik V
was the first registered vaccine against Covid-19 worldwide
, on August 11.
That speed raised alarms.
“Let's remember that this is a vaccine that several scientists questioned.
There are publications in
Nature
that questioned some data, because it was approved very early.
Then Russia was rectified, ”says López.
But he still "worries" about his approval speed.
“The vaccine could prove its safety after phase 3
is
concluded,
there is concern
about this.
If it passed this phase, it would be enabled to be administered, especially with the
emergency approval criteria
that are currently used for drugs in Covid-19, ”says Luna.
According to Omar Sued, president of the Argentine Society of Infectology (SADI) and also a member of the presidential advisory committee, Sputnik V - like many of the 13 vaccines that are currently in phase 3 - showed some positive results in phase 2.
The vaccine is administered twice, 21 days apart.
Photo Bloomberg.
“We are all very interested in seeing how they work, but we can't wait for all the studies to be finished to start preparing,” says Sued.
"So
the Government is already making all the preparations
to implement vaccination plans with any of the vaccines that demonstrate efficacy in the prevention of Covid and safety," he continues.
Anyway, Sued assumes that "
we still don't know when it will be approved
."
He says that it is expected that in the world, at the end of November, there will already be at least one approved vaccine.
From there, depending on the data, during December and January there may be some other approvals.
"But we still do not know for sure, because it depends on how these results are arriving," adds Sued.
Despite having "expectation" and "great interest" in vaccines, the president of SADI asks that we not lower our arms with
prevention measures
.
It is important to keep two meters away from other people, wear a mask, not have meetings in closed spaces, and avoid any crowded situation.
DD
