The interim research data of Sputnik V has not been published or peer-reviewed yet
Hyderabad: Sputnik V vaccine doses have arrived in the factory of Dr Reddy’s Laboratories in Hyderabad and a video of the cold storage has gone viral on social media. The unloading of the cold chain from Russia in the factory had a lot of people excited as they have taken videos and circulated it around.
The arrival of vaccine doses means that the trials for the vaccine would soon begin. The phase 2 and 3 trials are to be conducted in India to understand the safety and efficacy of the virus.
Dr Reddy’s Laboratories refused to comment on the viral video.
Data on its safety after trials in India will determine whether the vaccine can be given to the Indian population. The trial results are important for India as that will decide its use in the Indian population.
So far, the journal Lancet has stated that the Sputnik V vaccine is effective despite the low number of people on whom it was tried in Russia. The vaccine is being given in phases to Russians and they are being monitored. So far, the outcomes have been good.
According to interim trial results announced by Russia’s health ministry on Wednesday, Sputnik V vaccine has shown 92 per cent efficacy in preventing Covid-19 disease.
The interim research data of Sputnik V has not been published or peer-reviewed yet. “The calculation is based on the 20 confirmed Covid-19 cases split between vaccinated individuals and those who received the placebo,” said Russian Direct Investment Fund (RDIF).
The efficacy of the vaccine, developed by the Gamalaya Centre, was demonstrated on the basis of a first interim analysis obtained 21 days after the first injection.
There were no unexpected adverse events during the trials. Monitoring of the participants is ongoing, the ministry said.
The announcement follows results unveiled earlier this week by vaccine developers Pfizer and BioNTech, who said their vaccine was more than 90 per cent effective at preventing Covid-19.
Eleanor Riley, Professor of Immunology and Infectious Disease, University of Edinburgh in the UK, said while the results are encouraging, "I worry that these data have been rushed out on the back of the Pfizer/BioNtech announcement earlier in the week."
“The Sputnik data are based on only 20 cases of Covid-19 in the trial participants, compared to more than 90 cases in the earlier trial. This is not a competition,” he said.
“We need all trials to be a carried out to the highest possible standards and it is particularly important that the pre-set criteria for unblinding the trial data are adhered to avoid cherry-picking the data," Riley said, adding anything less than this risks a public loss of trust in all vaccines, which would be a disaster.
The Sputnik V vaccine is based on a human adenoviral vector platform that has proven safe and effective with no long-term side effects in more than 250 clinical trials globally conducted during the past two decades, the Russian health ministry said.