Russia has launched Phase 3 trials of its highly touted coronavirus vaccine to determine the jab’s long-term safety and effectiveness, authorities said Wednesday as questions surrounded the results of its Phase 1 and 2 trials.
Health Minister Mikhail Murashko said 31,000 out of the announced 40,000 volunteers have been recruited for the study, the state-run TASS news agency reported. Deputy Moscow Mayor Anastasia Rakova said that more than 35,000 Muscovites applied to take part in the trials, according to Interfax.
Neither official specified how many people have taken the adenovirus-based viral vector vaccine so far Wednesday.
Rakova added that the volunteers will receive a second shot of the same vaccine within 21 days of the first.
Russia began first deliveries of the Sputnik V vaccine for the general public this week.
A number of Russian state firm executives, cabinet members, city officials and party leaders have announced in recent weeks that they had received the vaccine.
The announcement comes after a group of prominent scientists highlighted “strange patterns” in the data published in the scientific journal The Lancet last Friday. The data included duplicate values for different groups of patients who had been tested with different formulations of the vaccine, the scientists told The Moscow Times.
The head of the state-run Gamaleya institute that developed the vaccine has also disclosed plans to develop a new vaccine that would double one’s protection from both Covid-19 and the flu.
Russia Begins Coronavirus Vaccine Rollout
Russia has begun releasing its coronavirus vaccine to the general public, the Health Ministry announced Tuesday as developers prepare to conduct large-scale clinical trials while administering the shot to civilians.
Its developer has said that a yearlong mass vaccination campaign would begin as soon as the Sputnik V vaccine entered civil circulation.
“The first batch of the Gam-COVID-Vac (Sputnik V) vaccine … passed the needed quality tests … and was released into civil circulation,” the Health Ministry said.
“First batches of the vaccine are expected to be delivered to the regions in the near future,” it added without specifying numbers.
Health Minister Mikhail Murashko said Monday that the first deliveries of Sputnik V would be “small for the time being.” He had previously said that the adenovirus-based vector vaccine would first be shipped to health workers and teachers.
The ministry’s announcement follows a flurry of reports saying that several high-level Russian government officials have received the Sputnik V vaccine and made public appearances in good health.
The state-run Gamaleya epidemiology and microbiology research center that developed Sputnik V has estimated that it would need to produce 80 million doses to achieve mass immunity.
Gamaleya said earlier that 25,000 out of the needed 40,000 volunteers have been recruited to take part in Phase 3 trials. Ten thousand of them will receive placebos in the double-blind trial.
Russia has officially reported more than 1 million coronavirus infections and almost 18,000 deaths since recording its first case in March. It is one of several countries racing to develop a safe and effective vaccine against Covid-19.
Recently published peer-reviewed research into early clinical trials said that Sputnik V did not cause serious adverse effects in patients but noted that longer trials are needed to establish its effectiveness.
More than 20 countries have requested over 1 billion doses of Russia’s vaccine despite safety concerns raised by health experts.