Volunteers break the hierarchy to raise doubts in testing Russia’s second COVID-19 vaccine

MOSCOW (Reuters) – Some of the volunteers in a test with Russia’s second vaccine COVID-19 broke the classification and conducted self-employed “citizen experiments” that they said raised concerns about the effectiveness of the injection.

A group of participants in the EpiVacCorona vaccine trial, developed by the Vector Institute in Siberia, has been testing antibodies and others to try to evaluate the injection and share their experiences.

The separation group is led by trial volunteer Andrey Krinitsky, who is not a scientist. The group’s findings were published in an open letter on its blog on Wednesday.

The letter says that some volunteers have tested antibodies available on the market, while others have registered cases of COVID-19 in their group and sent frozen blood plasma samples to independent laboratories to test the vaccine’s ability to neutralize an infection.

The scientists behind the vaccine, which was approved by the Russian regulator and added to the national inoculation program, say it is safe and effective. The test the separatist group was part of began in November 2020 and involves a total of 3,000 people across Russia.

EpiVacCorona, the second vaccine in Russia to be registered, is a synthetic peptide vaccine that uses a different technology than the more well-known Sputnik V vaccine.

Unlike Sputnik V, whose final stage, the results of the Phase III trial were published in the medical journal The Lancet in February, the developers of Russia’s second injection have not yet released the trial results on a larger scale.

However, more than 115,000 doses have been implemented in the national inoculation program, according to the authorities. More than 5 million doses are expected to be ready by July.

The government health surveillance body that oversees the development of the EpiVacCorona vaccine rejected Krinitsky’s claims in a comment published in the RBC newspaper on Thursday.

The watchdog noted the results of early stage I / II tests, which the vaccine developers said involved 100 people and showed that the injection is 100% effective in producing antibodies “specific for the antigens that make up the vaccine” .

Describing their “citizen experiments”, the authors of the open letter said they recorded 18 cases of people receiving COVID-19 three weeks or more after receiving the injection of EpiVacCorona. Among these were patients who required hospitalization due to COVID-19 lung damage, they said.

The group also said that 139 members did antibody tests recommended by vaccine developers, and 30% found no antibodies produced.

The government’s health watchdog did not respond to Reuters’ request for comment. In his previous response, he cited test results at an early stage and said: “Seroconversion, the production of specific antibodies by the body … for the presence of an antigen that enters the body during vaccination … was recorded in 100 % of volunteers 21 days after receiving the second injection. “

“We can conclude that the EpiVacCorona vaccine is an immunogenic and safe product for the prevention of COVID-19”.

Of Russia’s population of 145 million, 4.3 million people have already been fully vaccinated against COVID-19, almost all with Sputnik V, including about 1 million in the capital, according to authorities.

(Reporting by Polina Ivanova; Editing by Kate Kelland and Raissa Kasolowsky)

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