West Bengal will lose the chance to conduct a Phase II clinical trial of Russian COVID-19 vaccine candidate Sputnik V due to delay in granting state government approval, a senior official said on Sunday. responsible for an organization involved in facilitating the exercise.
Trials have been proposed to begin at the College of Medicine and Sagore Dutta Hospital (CMSDH) in the North 24 Parganas District, adjacent to Kolkata, later this week, along with six other centers in different parts of the country.
“We will not be able to hold the Phase II trials of the Sputnik-V vaccine at CMSDH due to the state’s slow approach to giving the approval. approval on November 4th and there is no response yet. It’s too late now.
“Even if approval is given today, it will not be possible to conduct the trials,” business development manager of the CliniMed LifeSciences site management organization, Snehendu Koner, told PTI.
He said that while the initial feasibility process at CMSDH has started with the other centers where the trials are to take place, approval could not be obtained in time.
After getting approval from the health department, consent from the hospital’s Institutional Ethics Board (IEC) is also required before starting the trials, Koner said.
The IECs of the other six institutions have already given the green light for testing.
When contacted, a senior state health department official, who did not want to be named, said: “This is an internal matter in our department. However, I think several public holidays due to festivals could have delayed the approval process. I can’t talk about it much. We will examine it. “
The site management organization had conducted the necessary investigations to verify the infrastructure and cold storage facilities at the Sagore Dutta Hospital before approaching the state health department for approval to conduct the trials. .
“Such approvals from the state health department are not required to conduct trials for vaccines or drugs. But surprisingly, we were asked to seek approval this time, which delayed the process and ultimately we lose it, ”he said.
Sputnik V’s clinical trials will be conducted by Dr Reddy’s leading pharmaceutical companies in coordination with the Russian Direct Investment Fund (RDIF).
RDIF will provide 100 million doses of its potential COVID-19 vaccine to Dr Reddy’s Lab.
Koner said Phase III of the candidate vaccine trial will start in India in January and the state health department and CMSDH will be urged to speed up the approval process.
The site’s management organization facilitates clinical trials by national and global pharmaceutical companies engaged in drug and vaccine development.
Citing the results of the provisional trials, Russia’s health ministry said earlier this month that the Sputnik V vaccine has shown 92% effectiveness in preventing COVID-19.
The announcement followed results released earlier by vaccine developers Pfizer and BioNTech, who said their vaccine was over 90% effective in preventing coronavirus disease.
The calculation was based on 20 confirmed cases of COVID-19 split between those vaccinated and those given the placebo, the RDIF said.
(Except for the title, this story was not edited by The Bharat Express News staff and is posted Platforms.)