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Appropriate safety, say Gamaleya researchers as they defend Sputnik V vaccine amid concerns

The letter stated that several experts had found problematic data in the results published in the first and second trial as well, especially around the non-availability of trial protocol.

Written by Anuradha Mascarenhas | Pune |
May 16, 2021 2:40:52 am
Family members of a deceased Covid-19 patient grieve outside Jumbo Hospital Shivajinagar in Pune on Saturday. (Express Photo: Pavan Khengre)

Even as the country looks at Sputnik V as a third option in boosting its vaccination drive against Covid-19, a group of international researchers has raised doubts over data discrepancies and lack of transparency around interim results from Phase 3 clinical trials of the Russian vaccine. However, in a clarification, researchers from Gamaleya Research Institute of Epidemiology and Microbiology, which is developing the vaccine, have said the vaccine has received registration in 51 countries, which confirms full transparency and compliance with regulatory requirements.

On May 12, The Lancet Journal published a letter from an international group of researchers from Sbarro Institute, Temple University, Philadelphia and other institutes which raised concerns about “substandard reporting of phase 3 interim results” of the vaccine. “We invite the investigators to make publicly available the data on which their analyses rely. Access to the protocol, its amendments and individual patient records is paramount as much for clarification and open discussion of issues,” the researchers wrote.

The letter stated that several experts had found problematic data in the results published in the first and second trial as well, especially around the non-availability of trial protocol.

In its clarification in the same journal, Sputnik V researchers said it was important to note that the safety and immunogenicity of the vaccine has been confirmed by researchers in Argentina, where vaccination with Sputnik V has already begun.

Preliminary data show the vaccine has an appropriate safety profile, and the most common adverse events were pain at the injection site, fever, and muscle pain, they said.

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A study of immunogenicity showed 16 titres of neutralising antibodies to SARS-CoV-2 after the first dose and 64 titres after the second dose, which correlates with the published results from vaccine clinical trial phase 1, 2 and 3, they added.

When contacted, India’s leading vaccine scientist Dr Gagandeep Kang, though, told The Indian Express, “The issues raised are definitely a concern.” She added: “I would wait till the WHO approves this vaccine.”

Dr Soumya Swaminathan, chief scientist at the World Health Organization (WHO), said prequalification of the vaccine will take two more months.

According to the WHO website, prequalification is a process that ensures vaccines used in immunisation programmes are safe and effective.

The first jabs of Sputnik V, with an efficacy rate of 91.6 per cent, were administered in a soft launch in India on Friday. The vaccination process against Covid-19 in the country began this year in January with two vaccines: Covishield and Covaxin.

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