Russia asked to apply for Sputnik V vaccine trials in India via local rep

Can't let the guard down for next 2-3 months against Covid, says V K Paul of NITI Aayog; ICMR chief sas 50% vaccine efficacy acceptable in case of respiratory viruses

India has asked the makers of Russian Covid vaccine ‘Sputnik V’ to file an application through an Indian representative for conducting trials in India, V K Paul, member (health) of NITI Aayog, told the media on Tuesday. 

He urged people to take precautions, particularly for the next two-three months, and avoid gatherings in the upcoming festive season. “They have identified who will apply on their behalf. We hope they approach the regulators soon with necessary documents,” said Paul. 

The Russian government had approached India for assistance in collaborating with Indian manufacturers, and to allow clinical trials as required by providing a regulatory pathway.  Paul added with cases on a rise, there was a need to stre-ngthen efforts to stop transmission between people. “We have to celebrate festivals with social distancing this year.” 

On the issue of efficacy of the vaccine, Balram Bhargava, director general of the Indian Council of Medical Research (ICMR) said that in case of respiratory diseases, and efficacy — vaccine’s ability to prevent clinical disease — of above 50 per cent is acceptable. 

“In case of a respiratory virus, vaccines are not 100 per cent effective. Though we aim for 100 per cent, we may get 50-100 per cent.” He was speaking in context of the draft guidelines issued by the central drugs standards control organisation for vaccine development, which said: “As it is possible that a vaccine might be much more effective in preventing moderate-to-severe versus mild Covid-19, consideration should be given for powering efficacy trials for formal hypothesis testing on a severe Covid-19 endpoint.” 

India, with over 4,000 cases per million, has exceeded the global average of 3,965. However deaths per million are almost half the global average at 64. 

The Prime Minister will review the status and response of seven states with a high burden of cases, including Maharashtra, Andhra Pradesh, Karnataka, Uttar Pradesh, Tamil Nadu, Delhi, and Punjab on Wednesday. More than 63 per cent of active cases are concentrated in these seven states. They also account for 65.5 per cent of the total confirmed cases and 77 per cent of total deaths.