Letter published in the journal Science The Lancet This Wednesday, 12th, criticizes the lack of transparency regarding the data of the third phase vaccine test Sputnik v, Funded by the Russian Direct Investment Fund. The paper was signed by nine researchers from universities in the Netherlands, Italy, France, the United States and Russia.
Scientists claim that access to research data is restricted and that there are “obvious errors and numerical discrepancies” in the results of the third study of the Russian immunization phase. They also point out that “several independent requests for access to the source data set” were made, but there was no response.
Last month, Anvisa denied the request Ten Brazilian countries to import Russian vaccine. One of the criticisms of the Brazilian body is the lack of accurate basic data on research. The Russian fund opposed the company, accusing it of refusing to recognize it The pressure of America.
In the letter The Lancet, Scientists say, it is necessary to access this data to confirm the alleged results. “Data sharing is one of the pillars of research integration,” they say. According to the text, researchers involved in the Sputnik V study say the data will not be shared until the experiments are completed.
Other concerns of scientists are related to the study protocol. According to the letter, the Spatnik V study included three interim analyzes, but this change is not on the official website that collects clinical trial data, clintrials.gov. Still in this case, they are recruiting volunteers and questioning them randomly. “There is no information as to what caused the exclusion of 13,986 participants.”
They also criticize the lack of “some important information” among volunteers, such as what is the dubious case of Govit-19, what diagnostic procedures were used, and the clinical parameters used to determine how much of the PCR test was performed. It is not possible to know whether all people with Govt-19 symptoms have been subjected to PCR tests without knowing that those responsible for the study will determine that it is a “suspicious case”. “It is very important to determine the effectiveness of the vaccine,” they say.
The letter noted that the effectiveness of the vaccine was the same for all ages and that there were other “very accidental” results. Scientists say it is possible, but reiterated the demand for access to the original data for “complete analysis.”
In a response published Wednesday in the same journal, scientists Instituteo Kamalea, Recalling that the vaccine, which develops the vaccine, is “registered in 51 countries”, which ensures “full transparency and compliance with regulatory requirements”.
Commenting on the review of the provisional analyzes included in the study, Kamaleya said the protocol with changes was submitted to the Lancet “for review with the remaining documents”.
The research also answers questions raised among volunteers about skepticism and coitus detection, but it does not answer skepticism. Kamaleya did not say what criteria were used to establish the suspicions or when the PCR test was performed.
Regarding the integrity of efficacy between different ages, Kamaleya said it “only confirms that the efficacy of the vaccine does not differ between age groups, as described in the article”. The company did not comment on requests for sharing of source data.
As for the volunteers, Kamaleya confirms that 13,986 participants were excluded from the study. “Some of these volunteers were selected, not yet random, while others were excluded according to the criteria for exclusion or did not meet the inclusion criteria.” They do not specify what the deduction and inclusion criteria are.