Experts raise doubts about Sputnik V’s data as jabs roll out in India

An international group of scientists has raised concerns over transparency and inconsistencies in data that could affect the overall efficiency

A group of international experts has raised serious concerns over the efficacy data from Russia’s Sputnik V vaccine trials even as the vaccine’s rollout kicked off in India.

The researchers zeroed in on issues that include not enough transparency, lack of clarity on protocols followed, methodology and a mismatch in interim data from the vaccine’s stage three trials, which they say could ultimately impact its efficacy.

“We have a serious concern regarding the availability of the data from which the investigators draw their conclusions,” the experts wrote in an article published on The Lancet journal website. “The investigators state that data will not be shared before the trial is completed, and then only by approval of stakeholders, including a so-called security department.”

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The researchers said much of the information was opaque or inaccessible, preventing them from independently verifying the data coming out of the trials. They implored the researchers who developed the vaccine to give them access to the data used to generate their statistics.

The concerns over trial data come as Dr Reddy’s Laboratories, the company manufacturing the doses in India, has administered its first dose in the country and set a price tag of Rs 995.4 per shot.

Russian researchers from the Gamaleya Research Institute of Epidemiology and Microbiology responded to the doubts raised by the international group of experts on the same platform, saying that the fact that they had been registered in 51 countries proved that their vaccine was safe to use and complied with regulatory requirements.

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“…to date, the safety and immunogenicity of the Sputnik V vaccine has been confirmed in multiple studies,” the Russian researchers wrote.

The researchers answered many of the red flags raised while brushing aside numerical inconsistencies as “simple typing errors that were formally corrected”. They also claimed preliminary tests conducted by researchers in Argentina supported their data and proved the vaccine was safe and effective.