Health
Proper safety, Gamareya researchers say they are defending the Sputnik V vaccine in concern
Even if the country sees Sputnik V as a third option to boost vaccination momentum COVID-19, A group of international researchers questioned the inconsistency and lack of transparency of data on interim results from Phase 3 clinical trials of Russian vaccines. However, for clarity, researchers at the Gamalaya Institute for Epidemiology and Microbiology, who are developing the vaccine, have confirmed that the vaccine is registered in 51 countries and is fully transparent and compliant with regulatory requirements. It states that there is.
On May 12, the Lancet Journal published a letter from an international group of researchers from the Sbarro Institute, Temple University, Philadelphia, and other laboratories on the vaccine’s “substandard report of Phase 3 interim results.” Expressed concern. “We invite investigators to make the data on which their analysis depend publicly available. The protocol, its modifications, and access to individual patient records are problem clarification and open It’s most important for discussions, “the researchers write.
The letter states that several experts have found problematic data in the results published in the first and second trials, especially with regard to the lack of test protocols.
In a description in the same journal, Sputnik V researchers note that the safety and immunogenicity of the vaccine has been confirmed by Argentine researchers who have already begun vaccination with Sputnik V. Said that it is important.
Preliminary data showed that the vaccine had an appropriate safety profile, with the most common adverse events being injection site pain, fever, and myalgia.
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Immunogenicity studies have shown that there are 16 drops of neutralizing antibody against SARS-CoV-2 after the first dose and 64 drops after the second dose. This correlates with the results published in Phases 1, 2 and 3 of the vaccine’s clinical trials.
When contacted, however, Dr. Gagandeep Kang, India’s leading vaccine scientist, said: India Express“The issue raised is definitely a concern,” she added, “waiting for WHO to approve this vaccine.”
Dr. Soumya Swaminathan, Chief Scientist of the World Health Organization (WHO), said pre-certification of the vaccine would take another two months.
According to the WHO website, pre-qualification is the process of ensuring that the vaccines used in the vaccination program are safe and effective.
The first jab of the Sputnik V was soft-launched in India on Friday with an effective rate of 91.6%. The domestic vaccination process for Covid-19 began in January this year with two vaccines, Covishield and Covishield. Kovacin..
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