Irene Hartmann
12/28/2020 2:08 PM
Clarín.com
Society
Updated 12/28/2020 2:17 PM
When little information is offered on an issue that worries a lot, it is common for social networks to fill up, badly or well, the doldrums, either with false information (
fake news
) or with true data that some actor - driven by personal interests- rolls.
The latter perhaps explains why
an internal ANMAT report
dated December 23 was
circulating on Twitter
this Monday
, precisely (
Clarín
confirmed
, after checking the authenticity of the document) one of those that served as support for that body to "recommend" the Ministry of Health approve the use of the
Russian vaccine
(Sputnik V) against the coronavirus, in people up to 60 years old.
It is a text signed by Nélida Agustina Bisio, technician of the Directorate of Evaluation and Registration of Medicines (DERM).
In five pages, the technique informs its superior Marcelo Alberto Carignani, director of the National Institute of Medications (INAME), dependent on ANMAT, the intermediate phase 3 data (collected until mid-December) that the Gamaleya Center presented to the Ministry of Health of the Russian Federation.
It follows that, as
it is not a minor document
, Bisio copied two heads of Carignani himself: Manuel Limeres and Valeria Teresa Garay, no less than those who occupy the second and third positions in the ANMAT line of command, headed, from now on, by the Minister of Health of the Nation, Ginés González García.
The study in question is a cut (or endpoint) that had already been advanced by Clarín: there are
12,296 volunteers from 18 to 87 years old
, part of the 40,000 that includes phase 3 of the Sputnik V vaccine. As is known, beyond Since the vaccination in Argentina will begin this Tuesday, the data in this document (until now, confidential) were not yet published in any scientific journal, something that would happen in January.
What does the report say?
At least three important things.
The first, that the effectiveness of the vaccine is higher than 91.4% deduced from phase 2, and that it would reach 96%.
The second, that the data provided in relation
to those over 60 years of age are "weak"
.
That is why the technicians in charge of the report explain that "based on these data for those over 60 years of age, it is recommended to wait for the report of more data on efficacy, immunogenicity and safety."
The third, that there were
12 adverse events considered "serious"
, of which 3 occurred in people over 60 years of age who had received the vaccine.
The text details that it was a case of renal colic, another of deep vein thrombosis and a “limb abscess”.
On the other hand, the “Safety Analysis” reports
8,704 minor adverse events in 4,401 volunteers
.
"The most frequent adverse event observed was flu-like syndrome in people who received the vaccine compared to placebo," says the report, adding that "local reactions were recorded at the injection site," more frequently in the vaccinated group. than the placebo.
Girl letter
A double-blind trial assumes that half of the volunteers receive the drug they are trying to test, and the other half, placebo (that is, nothing), with no idea - neither the participants nor those responsible for the study - who received what.
Before starting the test, it is defined at which points (or endpoints) partial data will be opened, to make
a detailed follow-up of the investigation.
In this case, it had been determined that with "at least 20" Covid-19 infections a portion of the data would be revealed.
That is why the report explains that “at the time of the closing of the database,
12,296 subjects and 27 cases of Covid-19
were included in the primary efficacy analysis
, according to what was planned for the first point interim analysis cut-off (at least 20 cases) ”.
As evaluated, "the population included in the two arms of the study did not show statistically significant differences in relation to the variables of age, sex, weight or race", and they deduce
"an acceptable safety profile" of the Russian vaccine.
An important fact (but of which many details are not given) that is several of the participants had comorbidities:
almost 26% of the volunteers in the "vaccine" group, and 27.3% in the "placebo" group.
As for those over 60 years of age, although Russia announced this weekend that it finally approved the emergency use of Sputnik V for that age group, the authorization given by the Argentine Ministry of Health does not include, for now, that age group. population.
And, in fact, the ANMAT internal report justifies it.
The argument is concessive, yes, but also cautious.
First, they explain that "a statistically significant difference is not observed (in terms of efficacy, compared with those under 60 years of age) in those over 60 years of age, which could be due to the low incidence of cases registered at the time of cut-off."
Then, they add: “The safety profile in people over 60 years of age did not differ from the safety profile observed in the rest of the population analyzed.
Considering that 1,029 subjects over 60 years were exposed to the product under investigation, a new safety analysis is suggested while waiting for adverse events that could be observed in a greater number of exposed subjects ”.
And a third paragraph clarifies that "the analyzed report does not yield data in relation to immunogenicity in people over 60 years old", from which it follows that "based on these data for people over 60 years old, it is recommended to wait for the report of more efficacy, immunogenicity and safety data ”.
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Look also
Sputnik V: why they sent only the first dose of the Russian vaccine
Coronavirus vaccine: winners and losers in the first distribution of Russian doses made by the Government