No safety data published about Sputnik-V other than it was tested on 38 volunteers.
As usual, mass-media doesn’t tell us the explicit truth. Yesterday Russia surprised the world with its first vaccine against Covid-19 named Sputnik-V. Russian President Vladimir Putin announced the safety is guaranteed because one of his daughters has already taken it. However, he has two daughters and we are not informed which one took Sputnik-V. What most media coverage is not accurate about is that Sputnik-V did not pass only phase 3. It didn’t even pass phase 2. In the ordinary process of vaccine development, a test vaccine must pass 3 phases after preclinical until approval. Sputnik-V passed only the first phase. Indeed, the Gamaleya Research Institute of Epidemiology and Microbiology at the Health Ministry of the Russian Federation registered a combined Phase 1 and 2 trial on a vaccine called Gam-COVID-Vac Lyo. However it was only in June. In available data, Russian researchers planned to test it on 38 volunteers in June but we don’t know if it was all the people who they tested the vaccine on or just the first lot. Either way, the institute has never published the trial data of Phase 1 and so-called Phase 2. Phase 2 requires hundreds of people split into groups, and Phase 3 requires thousands of people. Apparently one of the daughters of Vladimir Putin counts a thousand as a single person.
Sputnik-V was developed based on the technology that Johnson and Johnson is applying to their Covid-19 vaccine. It’s the new technology using Adenovirus, which is harmless cold virus to carry Covid-19 gene. The first vaccine based on this technology was the one for Ebola disease and this vaccine was approved only this June, when Sputnik-V entered its Phase 1 trial. The test vaccine of Johnson and Johnson reportedly provides protection to tested monkeys but it won’t enter Phase 3 trial at least until September.
Actually Sputnik-V is not the first “approved” vaccine against Covid-19. On 25th June, Chinese military approved the test vaccine of CanSinoBIO as a specially needed drug. It is not known if it’s mandatory for soldiers. This vaccine entered Phase 3 only 3 days ago, and it was in Saudi Arabia. This vaccine is also based on adenovirus technology. This is approved for limited use.
Needless to say, these two vaccines were pushed to approval by political pressure. Russia is not publishing the national excess death data on weekly basis so we will not know how effective or how risky the vaccines are.
FDA is expecting the potential vaccine to prevent or decrease its severity in at least 50% of possibility. However, we will not know how long the vaccine stays effective. The interval between the first wave and the second wave was approximately 3 months in most of the areas in the world. If we must take such a vaccine each time, we would end up taking the vaccine 4 times a year. Then the risk would be multiplied as well. We do not have any effective vaccine to any coronavirus strain. We should not sacrifice the safety in Covid-19 vaccine development.
Reliable sources.. https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
