Russian scientists have published results from early tests of their Sputnik-V coronavirus vaccine that was approved by the Russian government with much fanfare in August.
The study published in the British medical journal The Lancet on September 4 said patients involved in early tests developed antibodies with "no serious adverse events."
Russia approved the vaccine for domestic use on August 11, the first country to do so and before any data had been published. President Vladimir Putin said at the time of the announcement that the vaccine provided "sustainable immunity" and that one of his own daughters had been inoculated.
This raised concerns among some scientists that Russia was rushing to use a vaccine without safety data.
Experts said the first trials were too small and carried out over too short of a duration to prove safety and effectiveness. The study also did not use a placebo or control vaccine.
In the Lancet study, Russian researchers reported on two trials conducted in June and July each involving 38 healthy adults aged between 18 and 60.
Each participant was given a first dose, followed by a booster shot 21 days later.
They were monitored over 42 days and all developed antibodies within the first three weeks. The report said participants would continue to be monitored up to 180 days.
The early-stage trials also suggested the Sputnik-V vaccine produced a response from T cells, a key part of the immune system that may play in role in providing longer-term protection against the coronavirus.
A weakness of the study is that many of the participants were people in their 20s and 30s, while the coronavirus is particularly dangerous for unhealthy people and older populations.
The Russian vaccine uses modified strains of the adenovirus, which usually causes the common cold. It is then combined with a part of the new coronavirus, SARS-CoV-2, to trigger an immune response.
Expanding The Trial
Despite any drawbacks, Russian developers claimed great success and announced plans to expand trials.
Professor Aleksandr Gintsburg, director of the Gamaleya Institute that developed the vaccine with Russia’s Defense Ministry, told reporters that the vaccine triggers “sufficient” immune response “to counteract any imaginable dose infecting [a person] with COVID-19.”
“We are ready to assert that the protective effect of this vaccine will be detectable and remain at a proper level for 2 years, or maybe even more," Gintsburg claimed without presenting evidence.
A phase 3 clinical trial will involve 40,000 volunteers "from different age and risk groups,” according to the paper.
In a commentary in The Lancet, Naor Bar-Zeev of Johns Hopkins Bloomberg School of Public Health, who was not involved in the study, said the research was "encouraging but small."
"Showing safety will be crucial with COVID-19 vaccines, not only for vaccine acceptance but also for trust in vaccination broadly," he wrote.
"Since vaccines are given to healthy people and, during the COVID-19 pandemic, potentially to everyone after approval following phase 3 trials, safety is paramount."
The World Health Organization (WHO) has warned countries not to sacrifice safety to rush development of a vaccine.
The Geneva-based body says it will not endorse a vaccine that has not proven safe and effective.
There has been massive pressure globally to roll out a vaccine quickly as the pandemic continues to spread and countries seek to gain access to treatments for their population.
WHO said a total of 176 potential vaccines were being developed worldwide, including 34 being tested on people. Among those eight are phase 3 clinical trials, the most advanced involving tens of thousands people.
Kirill Dmitriev, who heads a Russian investment fund behind the vaccine, told reporters that The Lancet publication "is a powerful response to the skeptics who unreasonably criticized the Russian vaccine."
Dmitriev stated that Russia had received requests from 20 countries for the supply of 1 billion doses of the vaccine.
Russia has said that industrial production for the Sputnik V vaccine is expected to start in September.