President Putin announced the approval of Russian-developed Covid-19 vaccine after going through less than two months of clinical trials.
The president says that the vaccine went through the necessary tests and studies, and was deemed safe for us. Apparently, his own daughter had been given a dose already.
According to authorities, mass vaccinations will begin in October.
The unusual and unbelievably fast process of the vaccine development in Russia certainly is frowned upon by experts and suspected that there may have been processes that the developers deliberately skipped to hasten the production and trials of the drug.
The WHO reminded Russia recently to adhere to established protocols regarding vaccine development with an emphasis on the SARS-CoV-2.
Last August 10, Russia’s representatives have consulted the WHO to conduct a thorough review of the vaccine documentation and results, which is now referred to under the name Sputnik-5, by Moscow Gamaleya Institute.
Sputnik-5 is not enlisted by WHO as one of the vaccines that are officially under the third phase of clinical trials, that will require a huge number of a human volunteer to test both safety and efficacy. There is still inadequate information on how their studies are going.
While the speed is impressive, it does not convince medical experts that vaccines will be given within the year. As a matter of fact, the earliest time for which a vaccine can be distributed to the rest of the world is not until the middle of 2021.
Sputnik-V is engineered using strains from the virus that causes the common cold and modified to produce an immune response.
The alleged approval of the vaccine by the regulatory offices was announced even without the vaccine actually going through phase 3 trials. Even so, Russian Health Minister Mikhail Murashko insisted that it still proved safe and effective.
The rate at which Russia is producing the vaccine garners a lot of suspicions. The first clinical trials for their vaccine started only in June. The researches done by China, the US, and Europe started months earlier and yet those countries are still under the final phases of their trials.
Another worrisome fact is that the Russian research institute has not provided any findings from its study preventing experts from critiquing their work. Putin boasts Russia’s breakthrough in being the first country to have an approved vaccine. But that is still subject to verification.
The Association of Clinical Trials Organizations in Russia pleads for postponement of the green light and subjecting the vaccine to larger subject group studies, ergo, phase 3 trials. However, it is unclear as to how much can be done to prevent the government from marketing the vaccine after just phase 2 tests on 76 people.