The Comptroller General of Drugs of India has rejected the proposal of the laboratories of the pharmaceutical company Dr. Reddy to carry out the third phase trial of the Sputnik V vaccine from Russia, since the first trials have been conditional on a small group of population abroad.
After Russia became the first country to claim to have created an effective Covid-19 vaccine, Dr. Reddy’s laboratory joined the Russian Direct Investment Fund (RDIF) to conduct clinical trials of the Sputnik V vaccine, as well as its distribution.
However, world experts raised concerns about the safety of the vaccine, as it was released in a short time. The Union Health Minister Harsh Vardhan recently hinted that India has not given Dr. Reddy’s its go-ahead to go ahead with the vaccine trial among the Indian population.
The phase 3 trial of Sputnik V has been underway in Russia in around 40,000 subjects since September 1.
“After detailed deliberation, the committee recommended that the company should follow regulatory requirements and conduct a phase 2/3 trial in the country with adequate monitoring of the humoral and cell-mediated immune response,” said the committee that examined Dr. Reddy’s proposal.
Whats Next?
Rather than jumping straight into a large trial, Dr. Reddy has been advised to consider a small trial.
Other vaccine updates
Three candidate vaccines are currently being tested in India. The Pune-based Serum Institute of India, which has partnered with AstraZeneca to manufacture the Oxford Covid-19 candidate vaccine, is conducting Phase 2 and 3 human clinical trials. The vaccine developed by Bharat Biotech in collaboration with ICMR and the other developed by Zydus Cadila Ltd. are in the second phase of human trials.
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