Instances of infection among volunteers of Sputnik V trials, the world's first registered vaccine against COVID-19, have been reported, according to a top official of the developer of the Russian vaccine. Russian officials, however, say that the volunteers among whom coronavirus infections were reported could have received the placebo and not the actual vaccine.
After reports of coronavirus infections among vaccine trial candidates surfaced, the developer of the vaccine, Gamaleya National Research Center for Epidemiology and Microbiology of the Russian Healthcare Ministry, announced that they will consider disclosing the data on who among the volunteers were administered the vaccine and who among them were given a placebo. This will be done before summing up the results of the study, Russian news agency TASS reported on Wednesday.
Earlier, Deputy Research Director of the Gamaleya National Research Center, and Associate Member of the Russian Academy of Sciences, Denis Logunov, reported that trial participants will find out whether they received the vaccine or the placebo only after the end of tests. The centre’s director Alexander Gintsburg reported that the last group of volunteers out of the total of 40,000 may be inoculated by the end of January 2021.
"...Apparently, there are (coronavirus) infections (among the post-registration trials participants). At some point in mid-November, the provisional results will be summed up, then we will find out the difference between the placebo and the test samples," Gintsburg was quoted as saying to TASS.
In response to a question on how the results can be obtained before the end of the study if the data can be disclosed only after its completion, the director said that currently, the center is thinking of introducing relevant amendments to the legislation in Russia. The center's director also explained that coronavirus infections among the volunteers may be related to the fact that an individual wasn't vaccinated, that is, received the placebo.
On August 11, Russia became the first country in the world to register the vaccine against coronavirus which was named Sputnik V. Russia faced criticism for approving a vaccine before conducting crucial phase-3 trials. Post-registration trials of the preparation started in Moscow on September 7, with the first volunteers receiving the vaccine on September 9.
In all, 40,000 people participate in the program, 10,000 of whom will receive a placebo instead of the vaccine, TASS reported. Earlier, the Janssen-Cilag company, the pharmaceutical division of US multinational Johnson & Johnson, temporarily suspended clinical trials in Brazil of a vaccine against COVID-19.
Earlier, the Oxford COVID-19 vaccine trial was temporarily paused as one of the participants reported a suspected severe adverse reaction. The trial resumed after a safety review.