NEW DELHI: Russia has claimed that phase 3 clinical trials of the Covid-19 vaccine, which it launched on Tuesday, will also be conducted in India, among other countries, but officials in the Union Health Ministry dismissed it saying there was no talk on any such collaboration yet.
The controversial vaccine — Sputnik V — has been approved by Russia even amid major concerns on its safety and efficacy as it has not completed human trials yet and has been tested on less than 100 individuals. The first clinical trials of the vaccine had begun only on June 17.
On Tuesday, Russian President Vladimir Putin announced the approval of the vaccine for use, claiming it as a “world first,” amid continued concern and unanswered questions over its safety and effectiveness.
The Russian government has announced that its mass production will start next month and it will be available for public use by October. The vaccine has been developed by Gamaleya Research Institute and the Russian Defence Ministry, and has been created using inanimate particles developed based on adenovirus, a class of virus that causes the common cold.
The Russian Direct Investment Fund, a government body, which is financing the production of Sputnik V, on its official website declared that it sees “strong global interest in the vaccine and plans to conduct phase 3 clinical trials in different countries, including Saudi Arabia, UAE, Brazil, India and the Philippines, and start mass production in other countries in partnership with local sovereign wealth funds, including India, South Korea and Brazil, as well as, in Saudi Arabia, Turkey and Cuba.”
“At least 20 countries had expressed interest in obtaining the Sputnik V, including UAE, Saudi Arabia, Indonesia, Philippines, Brazil, Mexico and India,” the RDIF also said in a statement. Official sources said the launching of phase 3 trials for any vaccine requires appropriate regulatory approvals by the Drug Controller General of India.
“And as far as our information is concerned, there is no movement on that front yet,” said a senior official.
“Besides, there is also no data from phase 1 and 2 trial of the Russian vaccine yet,” the official added.
Another official in the ministry indicated that it’s also possible that some states would have approached Russia with queries on the vaccine.
A senior official in the Indian Council of Medical Research denied any information on the matter, while Dr V K Paul, a member (health) Niti Aayog who has been made chief of an expert group on Covid-19 vaccine administration, could not be reached for his comments despite repeated attempts.
Sources, meanwhile, said Russia has also approached Bharat Biotech, a Hyderabad-based vaccine manufacturer, to produce its vaccine in large quantities, but the firm is yet to respond.