Irene Hartmann
12/24/2020 4:48 PM
Clarín.com
Society
Updated 12/24/2020 4:48 PM
During these hours, an uncomfortable question is circulating around the Russian Sputnik V vaccine against the coronavirus.
Is it fair and reasonable for us to demand
more scientifically validated information
from this development?
Leaving aside any political, geopolitical or other bias, there are several elements that, step by step, were consolidating the unpleasant feeling that (if the much-promised scientific publication with phase 3 data does not mediate) next week could start a vaccination campaign
with a drug whose effectiveness and safety are not adequately proven
.
Nothing that follows is a questioning of the Russian vaccine itself: such a judgment exceeds the capabilities of this chronicler, not to mention that the vaccine could (and hopefully so) work wonders.
We do not know.
Next, the milestones that were installing more uncertainties than certainties about this drug.
This Thursday,
Clarín
accessed the text through which the ANMAT recommended to the Ministry of Health of the Nation to authorize, for emergency use, the Russian vaccine.
The body deduces the effectiveness and safety from a pair of axes.
A vial of the Russian Sputnik V vaccine against the coronavirus.
/ Reuters
They say that "the known and potential benefits for the health of the population
are greater than the uncertainty
" based on the fact that both the Gamaleya center (responsible for releasing the vaccine batches) and the production plants "are
acceptable and compatible
with the established in the Argentine regulations.
In addition, they clarify that "the information available in the preliminary cut shows
safety and efficacy in a higher than acceptable range
."
They refer to the
91.4%
effectiveness
declared by the representatives of the Gamaleya Center and the Russian Direct Investment Fund (RDIF), based on three
endpoints
or cuts they made (the last of them was reported on December 14), as pre-established by the trial protocol.
These data are auspicious.
They were communicated to the world, but
are not based on peer-
reviewed
scientific publications
.
For the scientific field, it is like considering yourself a "graduate" before rendering the last final.
Does it make sense that the ANMAT has recommended and the Ministry authorized the vaccine, when that central information is not consolidated?
The arrival of the Russian vaccine to Ezeiza, this Thursday, with the Chief of Staff, Santiago Cafiero, and the Minister of Health, Ginés Gonzalez García.
Photo JGM
The whole world resigned itself to using the Covid-19 vaccines, even before the laboratories concluded phase 3 of their trials.
Much less, phase 4, something that - reported this media - could also be problematic.
But, although most of the dance vaccines will complete the third phase of their research only between 2021 and 2022, they have in their favor having published preliminary phase 3 results, something that has not yet happened with the Russian vaccine, although they
promise, we repeat , a paper for the end of December
.
Perhaps, aware of this "loose leg", those responsible for the Russian vaccine offered
numerous press conferences
in these weeks
.
The first were interesting, but the last two are worth mentioning: in one, this Wednesday, great expectations had been generated.
It was only for Argentine journalists, exclusively, it would last half an hour and questions could be asked.
The result was somewhat disappointing.
What was already known was exposed, it lasted 10 minutes and central details were avoided, such as
what will happen to the 300,000 doses of the second compound
that the people who will receive the first dose from next week will require.
The doubts about the 5 million vaccines that should come in the summer were not answered nor were certain details of the efficacy (supposedly proven) given in those over 60 years.
Russian President Vladimir Putin created a small stir when he announced that he had not been given the Russian vaccine, being over 60 years old.
/ AP
It does not mean that they do not have them or that the ANMAT has not accessed the "
promised paper
" but not yet published.
We just don't know.
And this Thursday, in a second press conference, if one were to set aside the several minutes used by those responsible for the drug that has the Argentine population in suspense to highlight the landing with the 300,000 doses in Ezeiza and make allusions to a "
reaction refusal by some Argentine media
”for apparent“ political issues ”, there were no news either.
What was said was repeated in previous press conferences and newsletters, which, of course, do not replace papers.
Comparisons
This week, the ANMAT approved the registration requested by Pfizer-BioNtech, without the need for the Ministry of Health to use the "super power" that it achieved with the exit of law 27573, which gives it the green light to authorize a vaccine with the only "recommendation" of the ANMAT.
Comparing
both documents
(the authorization for Pfizer, on the one hand, and the recommendation of Sputnik, on the other),
the differences are very large
.
While that of the
Russian vaccine is labeled as a “
technical report
”, but it is in the column behind an understandable but very general line of argument, that of Pfizer is a
conventional
“
disposition
”, in response to the request that the laboratory had made to register its vaccine (rather , the
generic BNT162b2
, commercial name
Cominarty
) in the ANMAT Registry of Medicinal Specialties.
What did the body do?
The logical thing for these cases: the
Directorate of Evaluation and Control of Biologicals and Radiopharmaceuticals
evaluated the documentation presented and concluded that "
the new medicinal specialty (...) presents an
acceptable benefit-risk balance
, thus allowing to sustain the granting of registration and conditional authorization of the product for the requested indication
”.
The ANMAT, which in this case "has a voice and vote", puts
conditions
on Pfizer, undoubtedly the usual ones in the field.
The most interesting are two.
The first, “that it must have the authorized Risk Management Plan (...) at the time of submitting the application for effective marketing authorization, so that a
close monitoring of the safety and efficacy
of the medicine can be carried out. .. "
The second, that it submits "
periodic safety reports
every six months after the effective marketing of the product ..."
Informational pothole
One of the voices that has been warning what in his opinion are "
untidy
" in relation to the Russian vaccine is
Adolfo Rubinstein
, former Minister of Health of the Nation, doctor of Medicine and Master in Clinical Epidemiology.
“The first strange thing that happened was the announcement, in August, by the Russian government before anything was published.
Vladimir Putin said he had an effective vaccine when he
hadn't even started phase 3 of the trial
.
There the Argentine Government got on ”, he pointed out.
Rubinstein noted that "Moderna does not have published phase 3 results either, but there is a complete public dossier, which is not a press release."
In addition, he recalled "the issue of whether the Argentine laboratory HLB Pharma participated or not, an issue that no one fully understood."
Also "there were back and forth with the number of doses, and it seems to dominate an
urgent need to vaccinate testimonially before the end of the year
, although it implies introducing an alternative procedure that is protected by law but establishes a
less rigorous
form of
authorization
."
In short, "what the ANMAT did with this recommendation is not a technical report," Rubinstein evaluated, and concluded: "Surely nothing will happen and the Russian vaccine will be effective.
The issue is how things are done
”.
DD
Look also
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