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Home Specials OpIndia Explains While opposition leaders claim credit for Sputnik-V vaccine approval, here's how it is the...

While opposition leaders claim credit for Sputnik-V vaccine approval, here’s how it is the latest step in a process that began in Sep 2020

The approval today has suddenly given some people cause to fall prey to their own false notions about the whole process. Some have decided it is a moment to pay tribute to the renowned intellect of Rahul Gandhi.

Russia’s Sputnik-V vaccine has received emergency use approval from the Subject Expert Committee of the Central Drugs Standard Control Organisation and now it awaits the final approval from the Drugs Controller General of India. Calls were being made to grant approval for the same citing the second wave in India.

The approval today has suddenly given some people cause to fall prey to their own false notions about the whole process. Some have decided it is a moment to pay tribute to the renowned intellect of Rahul Gandhi.

Others believe the approval has come forth due to the voices raised by the opposition.

In reality, the emergency use approval for Sputnik-V today is another step in a process that began as early as September 2020 when Dr. Reddy’s said that they were looking to begin late-stage Indian clinical trials for the vaccine within the next few weeks. This has been pointed out by users on social media.

“We want to get to the first step – which is the commencement of the clinical trials by getting the necessary approvals from the Indian regulators – within the next few weeks,” Deepal Sapra, CEO for API and pharmaceutical services at Dr. Reddy’s (DRL), had told Reuters in September.

It was reported that the trials were part of a deal between Russian Direct Investment Fund (RDIF) and Dr. Reddy’s which involved the Indian firm conducting the Phase 3 trials in India and pursue local regulatory approvals. “I think it’s going to be several months before we accomplish all the steps in the process,” Sapra had said back then.

Dr. Reddy’s received the approval to conduct the Phase 3 trials from the Drugs Control General of India (DCGI) in January 2021. It was after the Data and Safety Monitoring Board (DSMB) reviewed the safety data of the Phase 2 clinical trials and recommended the next phase of trials.

G V Prasad, Co-chairman and Managing Director, Dr. Reddy’s Laboratories had said, “This is an important milestone in the progress of this pivotal clinical trial of the vaccine. We expect to commence the phase 3 study within this month and will continue to fast-track our efforts to bringing in a safe and efficacious vaccine for the Indian population”.

On the 19th of February, Dr. Reddy’s sought emergency use approval for the Sputnik-V vaccine with Phase 3 trials due to be completed on the 21st of February. It had said then that the safety profile of the phase 2 study and the interim data of the ongoing Phase 3 trials would be presented.

It was reported on the 16th of March that the Phase 3 trials had been completed and results were due in April. The phase involved 1500 participants and was randomised, double-blind, parallel-group, and placebo-controlled study in India.

On the 2nd of April, the authorities sought more data for emergency use approval. A source said, “No approval was given to Sputnik V on Thursday. Some queries have been asked on safety, efficacy, and logistics, which the firm will have answers to at the next meeting.” “Current storage temperature requirement is at minus 18 degrees Celsius. We are working on other storage conditions as well,” a spokesperson for DRL had said.

Ten days later, on the 12th of April, the SEC met today to discuss the emergency use approval for the Sputnik-V Vaccine and the clarifications that were provided. Following the meeting, approval for the same was granted. And now, it awaits the DGCI’s final approval.

Therefore, while politically motivated individuals may be inclined to credit their favoured opposition leaders for the development, the fact of the matter is that it is only the logical step of a process that began September last year.

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OpIndia Staffhttps://www.opindia.com
Staff reporter at OpIndia

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