Sputnik V: Russian Covid-19 Vaccine Developers Respond To Criticism Of Clinical Trial Data In Medical Journal Lancet

After criticism of the clinical trials data of the Russian Covid-19 vaccine 'Sputnik V' by global scientists, the developers of the vaccine have defended the data presented by them in medical journal Lancet and promised to provide access to health records of certain volunteers.

In a letter to the Lancet's editorial board, which published on medical journal's website on Friday (18 September) evening, the Sputnik V developers emphasised that all the data presented in the article published earlier in the journal were obtained in "experiments and double checked", reports Russian News Agency TASS.

The Sputnik V Covid-19 vaccine has been developed by Russia's Gamaleya National Research Center of Epidemiology and Microbiology along with the Russian Direct Investment Fund (RDIF), and its initial clinical trials were completed in June-July.

In the letter, the deputy research director at the Gamaleya Center Denis Logunov and his co-authors promised to provide access to health records of certain volunteers, so that all the existing issues are clarified.

"The coincidences that emerged, especially at the early points (values are low and are close to baseline), are associated with the discreteness of the data, as well as with the small number of participants in the groups. We acknowledged this as a limitation of the study in the discussion section of the Article," the letter reads.

"We confirm that individual participant data will be made available on request to DYL and that after approval of a proposal, data can be shared through a secure online platform," the Russian scientists were quoted as saying.

The clarification came after some scientists from US, Italian and other universities wrote an open letter to the Russian researchers on 7 September. In the open letter, they pointed out to certain statistical anomalies that were detected in some of the experiments depicted in article by the Russian scientists.

Earlier on 4 September, the RDIF and Gamaleya Center announced the publication of a scientific article on the results of Phase I-II clinical trials of Sputnik V, world's first registered Coronavirus vaccine.

In the article, the Russian researchers said that the Sputnik V vaccine generated a stable humoral and cellular immune response in 100 per cent of the participants of clinical trials.

The vaccine has been developed on a human adenoviral vectors platform that had been used for a number of other vaccines.