Updated: May 15, 2021 10:35:19 pm
As a soft launch of Sputnik V was announced in the country, concerns have been raised by an international group of researchers over “data discrepancies and lack of transparency around interim results from Phase 3 clinical trials” of the Russian vaccine. However, in a response published in medical journal The Lancet, researchers from Gamaleya Research Institute of Epidemiology and Microbiology have said that Sputnik V has received registration in 51 countries, which confirms full transparency and compliance with regulatory requirements.
On May 12, The Lancet published a letter from an international group of researchers from Sbarro Institute, Temple University, department of biology, Philadelphia and other institutes that raised concerns about “substandard reporting of phase 3 interim results”.
“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 states that several experts had found the data problematic in phase 1/2 results published earlier. Their concern is about the trial protocol that has not been made publicly available or explained.
Meanwhile, the Sputnik V team researchers responded to the correspondence, stating that it was important to note that the safety and immunogenicity of the Sputnik V vaccine has been confirmed by researchers in Argentina, where the vaccination with Sputnik V has begun.
“Clear and transparent regulatory standards exist for provision of clinical trial data, including data reported in clinical study reports that are considered sufficient for regulatory review and approvals. The reporting of the interim analysis1 in the phase 3 Sputnik V clinical trial fully complies with those standards. It is on this basis that Sputnik V has received registration in 51 countries, which confirms our full transparency and compliance with regulatory requirements,” they said.
The Russian researchers further said that 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.
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 phase 3 in Russia, they added.
Leading vaccine scientist Dr Gagandeep Kang said that while authors have responded, however, “the issues raised were definitely a concern”. “I would wait till WHO approves this vaccine.” Dr Kang told The Indian Express.
Dr Soumya Swaminathan, chief scientist at WHO ,when contacted, said that pre-qualification of this vaccine will take two more months.
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