India's Drug Regulator Declines Large-Scale Trials For Russian Vaccine

Dr. Reddy's who are partnering with the Russian Federation for Sputnik V have been asked to conduct Phase II/III trials

India's drug regulatory body has asked Dr. Reddy's Laboratories to reformulate its strategy for clinically testing Russia's vaccine Sputnik V in the country in a large-scale trial and opt for smaller trials instead.

Hyderabad-based Dr. Reddy's Laboratories approached the Central Drugs Standard Control Organisation with a proposal for conducting Phase III trials of the adenovirus vector-based vaccine. The subject expert committee for COVID-19, however, noted that the safety and immunogenicity data supporting the use of the vaccine was for a very small population that did not include Indians.

The Russian vaccine was approved for COVID-19 use by the Russian authorities on August 11 without large-scale clinical trials. It was the first candidate to receive regulatory approval from any government authority. Data regarding the safety of the vaccine was also prospectively published in the Lancet after Russia started enrolling for Phase III trials.

Dr. Reddy's which signed an agreement with the Russian Direct Investment Fund in September has been asked to re-submit a proposal for conducting Phase II/III trials in the country. Only after studying the new proposal that outlines the detailed protocol for Phase II/III trials, the body will approve the pharmaceutical to conduct the trials for this vaccine. The firm is expected to observe and study both antibody-related and T cell-related immunity against SARS-CoV-2.

Currently, there are three vaccine trials being tested in the country. Pune's Serum Institute of India is conducting Phase II/III trials of the Oxford-AstraZeneca vaccine. Bharat Biotech's indigenously produced vaccine using a strain isolated by the National Institute of Virology has submitted a protocol for Phase III trials for its Covaxin candidate. Zydus Cadila's vaccine is in Phase I/II trials at various centres in the country.

Another Hyderabad-based pharma Biological E has submitted a Phase I trial protocol for its vaccine candidate that targets the receptor binding domain of SARS-CoV-2. The CDSCO has asked the firm to present its data on animal toxicity prior to initiating any trials.

Union Health Minister Dr. Harsh Vardhan had stated in his 'Sunday Samvaad' that India would receive adequate doses of the COVID-19 vaccine by July 2021. India with the second highest COVID-19 case load, is likely to cross US' caseload in a few weeks.

Concerns About Sputnik V

As Sputnik V is being rolled out faster than most other vaccines, the subject expert committee highlighting the small-scale efficacy studies follows regulatory protocols. Vaccines are scrutinised through stringent regulatory practices as each stage/ phase of clinical trials is observed for safety, side effects, development of an immune response, and efficacy under ideal conditions. Several scientists across the world had critiqued the speed at which Sputnik V was approved for use when Russia announced its decision on August 11.

In the findings published in the Lancet on September 4, the scientists from Gamaleya Research Institute of Epidemiology and Microbiology stated that the vaccine did not generate any adverse scientific reactions while inducing an immune response. On September 7, another scientist wrote an open letter to the editor of the Lancet requesting that the collected data be made public as there were discrepancies in the data published in the journal.

Vaccine Trials

Vaccine development follows a protocol of pre-clinical development where the various vaccines are experimented on different animals that have a similar genetic make-up. Post this, the vaccines follow three phases of trials. Phase I with a few volunteers. If they develop an immune response after being the administered the vaccine, Phases II with 100-1,000 volunteers and Phase III with more than 1,000 volunteers are followed. Phase II/III trials will be with around 1,000 participants



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