Behind the ANMAT report leak Over the Adverse effects who presented the vacuna rusa Sputnik V, the referents of Instituto Gamaleya went out to explain the details about these side effects in 12 people.
While i know distributes the first doses to the provinces and tomorrow Tuesday the vaccination begins, a document sent to the authorities came to light on December 23, hours before the first doses of the vaccine from Moscow arrived in Buenos Aires.
According to the “Report of the Directorate of Evaluation and Registration of Medicines”, most of the symptoms were flu, common in a vaccine of this nature, but 12 people had more serious conditions such as “kidney colic, deep vein thrombosis, and a limb abscess“.
After this filtration that generated controversy, from the Gamaleya National Center for Epidemiology and Microbiology from Russia sent an email to Argentine media, including PROFILE, in which their authorities explain these side effects.
He deputy director of the Center, Denis Logunovcommented: “12 subjects in the Sputnik V clinical study have experienced serious adverse effects (SAE) from 12,296 subjects.”
“Subjects have experienced serious adverse effects not related to the vaccine based in pre-existing diseases and documented prior to the start of the trial, including the kidney stone disease, deep vein thrombosis, and limb abscess caused by unfortunate nail clipping, “he said.
What the ANMAT says about the leaked document on Sputnik V
“All of these conditions have been resolved successfully. All SAEs should be reflected in accordance with the requirements of clinical trial procedures, including those that are not related to inoculation“he added.
For his part, the Chief of Staff of the Argentine Ministry of Health, Lisandro Bonelli, explained: “They are very basic things that do not generate gravity in human health. giving it a dimension that doesn’t make sense“.
According to interim phase 3 results of the Russian vaccine to which Anmat had access to issue its recommendation for the authorization of “emergency use”, Sputnik V, demonstrated in clinical studies to be safe by not causing serious adverse effects and one efficiency greater than 91.4%.
Why was the Russian Sputnik V vaccine approved?
It is a vaccine that uses a platform (or technology) called “non-replicating vectors“; vectors are viruses that are genetically modified so that do not have the ability to reproduce in the body (and therefore innocuous) and are used to transport genetic material of the virus to be immunized.
In this case, Sputnik V uses human adenovirus as vector and, unlike other candidates, uses two adenoviruses (26 and 5) to provoke a longer and longer response at immune system; to these adenoviruses a part of the spike (or spike) protein that belongs to the coronavirus to provoke the immune response.
“Adenovirus vectors are genetically modified common flu viruses that cannot reproduce in a human body. When the Sputnik V vaccine is used, the coronavirus itself does not enter the body since the vaccine only contains Genetic information about part of its outer protein layer (the spike protein) “, explained its developers.
And they described that “this completely eliminates the possibility of getting infected as a result of vaccination and at the same time elicits the body’s stable immune response. “
Three infectologists answer questions about the Sputnik V vaccine
On December 14, the Gamaleya Center announced the results of the third and last control point of phase three that contemplated the evaluation of the efficacy among 22,714 volunteers 21 days after receiving the first dose of the vaccine or placebo in which a 91.4% efficacy rate.
The analysis of the efficacy of the vaccine at this final checkpoint was carried out on the basis of 78 confirmed cases identified in the placebo group (62 cases) and in the vaccine group (16 cases); the ratio between the placebo group and the vaccinated group is 1 to 3.
In this same court, the vaccine demonstrated 100% efficacy against severe cases of coronavirus: there was 20 severe cases of coronavirus infection among confirmed cases in the placebo group and no severe cases in the vaccine group.
At once, no unexpected adverse events were identified as part of the investigation: some of those vaccinated had minor short-term adverse events, such as pain at the injection site and symptoms similar to those of the flu, such as fever, weakness, fatigue, and headache.
On September 4 the magazine The Lancet had published an article on the results of phase I and phase II clinical trials and it is estimated that in The results of phase 3 will be published in the next few weeks.
“The fact that the interim phase 3 results have not yet been published in a scientific journal, beyond the fact that It is not the first approval in the world without the phase being published 3 (the United Kingdom approved the Pfizer before that happened) is not a requirement or a condition for an emergency use approval, “the infectious disease doctor told Télam. Florencia Cahn.
And he continued: “You have to bear in mind that none of the candidate vaccines completed phase 3 because this phase requires a medium and long-term follow-up; what are being published are interim results in all cases that have a sufficient support to allow their emergency use. “
Exclusive: where does the vaccination start and which governors want to give Sputnik V
On December 5, Russia began a mass vaccination of the health personnel, social workers and teachers in the capital, Moscow, and on December 26 the indication to vaccinate was extended to those over 60 years, after analyzing the results of a specific study for the population of that age.
Regarding this aspect, Cahn – who is President of the Argentine Society of Vaccination and Epidemiology (SAVE) – stated that “the phase 3 study always included people over 60 years of age, in fact there are more than 1,300 volunteers of that age group, which constitutes the 11% of total participants; What happened was that the results were after those of the rest of the population, so for that reason it had not been indicated first; but currently already efficacy and safety are known to be the same throughout the population“.
Argentina received 300 thousand doses with which it will begin to vaccinate as of this Tuesday, after being approved by the Ministry of Health of the Nation based on a recommendation from Anmat, which carries out a review of the results of Sputnik V from the November 2nd.
Consulted on why this approval was made by the Ministry and not the Anmat, the infectologist who is a member of the Expert Committee that advises the Health portfolio, reported that “there are two different mechanisms: as the Pfizer laboratory has representatives in the country, it presented the documentation directly to Anmat while the Gamaleya vaccine was a presentation of State to state, then Anmat recommended and the approval was given by the Ministry, both are valid“.
An advantage of Sputnik V over other candidates is that the lyophilized (dry) form of vaccine can be stored at a temperature of +2 to +8 degrees Celsius, which makes logistics for its transfer and storage easier; However, in this first shipment Argentina received the liquid formulation that needs to be at a temperature of minus 20 degrees.
The director of the Gamaleya Center, Alexander Gintsburg, confirmed this Monday that “the 300,000 doses delivered to Argentina are the first component of the vaccine” and assured that “The second component of Sputnik V will be delivered in January in full compliance with the schedule.”
EuDr / Ds