Ever since Russia dropped the bombshell announcement of giving a regulatory approval for the “Sputnik V” vaccine for Covid-19 on Tuesday, the development has been met by scepticism. One of the biggest concerns is that the approval comes before the completion of human trials. Russia was yet to start a larger trial involving thousands of participants, commonly known as a Phase III trial, which is normally considered an essential precursor to a regulatory approval.
Russian President Vladimir Putin claims the vaccine offers “sustainable immunity” against Covid-19. He said one of his daughters had received the inoculation and felt better.
Experts say the lack of published data on Russia’s vaccine have left scientists, health authorities and the public in the dark. There exists little clarity about how the vaccine is made and details on safety, immune response and whether it can prevent Covid-19 infection, news agency Reuters reported.
Top US infectious disease official Dr Anthony Fauci said he had not heard of any evidence that the vaccine was ready for widespread use.
Russian business conglomerate Sistema has said it expects to put the vaccine, developed by Moscow’s Gamaleya Institute, into mass production by the end of the year.
According to Russian government officials, the vaccine will be first administered to medical personnel, and then to teachers, on a voluntary basis at the end of this month or in early September. Mass roll-out in Russia is expected to start in October.
The vaccine is administered in two doses and consists of two serotypes of a human adenovirus, each carrying an S-antigen of the new coronavirus, which enter human cells and produce an immune response. The platform used for the vaccine was developed by Russian scientists over two decades and had formed the basis for several vaccines in the past, including those against Ebola.
