Russia claims to become the first country to complete successful clinical trials of COVID-19 vaccine on humans. The results have proven positive medical effects.
On July 12, 2020, the Russian media has reported that the COVID-19 vaccine will be made available for commercial use or not as the Russian regulatory authority has yet to give a nod for it.
Cheif researcher Elena Smolyarchuk of Sechenov University has said
the research has been completed and it proved that the vaccine id safe.
The university has begun clinical trials of vaccines produced by Gamalei Institute on June 18, 2020. The first group of 18 volunteers received the vaccine on June 18, 2020, and the second group of volunteers got it on June 23, 2020.
After taking the vaccine all volunteers were kept in a hospital in isolation for 28 days under medical care. These volunteers are expected to be discharged from the hospital on July 15, 2020, and the second group will be discharged on July 20, 2020. However, they will remain in the hospital as outpatients for further medical supervision.
Stance of WHO on the vaccine:
The draft landscape of COVID-19 vaccine candidates prepared by WHO has still listed the Russian prepared vaccine on Phase-I trial. As of July 7, 2020, WHO data shows that the only candidates to reach Phase-III trials are Oxford -Astrazeneca and China’s Sinovac’s vaccine. These are based on inactive COVID-19 patient.
In India too, Covaxin by Bharat Biotech and ZyCov-D by Zydus Cadila companies have got the approval from WHO for clinical trials.
World Health Organization has also mentioned it is the official website about 21 other candidates who are in the race of vaccine making and they are also in key trails phase currently. Though many of these have shown positive results in earlier trials, no vaccine has got the approval for commercial use.
Has Russian Vaccine completed all stages of clinical trials? Is the euphoria unfounded?
Russia till now has not published the data about the clinical trials and the stages it has completed. Even the pre-clinical stage and its results were also not informed to the outside world.
So, knowing the efficiency of the vaccine at this stage would be difficult to certify by the WHO. So, the Russian regulator has to take a call now whether it can be made available for commercial use or not. If there are no side effects found, then the regulator can allow the vaccine for commercial use though it has not completed all the stages.
On a positive note, if Russian regulators do so, then the Indian candidates will also have the chance to follow the same path before they complete the Phase-III trials.