Wednesday, July 7, 2021

Indian makers of Sputnik V may seek waiver for local Phase-3 trials – ET HealthWorld


Five of six Indian companies, that have entered into manufacturing arrangements with sovereign fund Russian Direct Investment Fund (RDIF) for Covid-19 vaccine Sputnik V, may seek a waiver for conducting local Phase-3 clinical trials.

One of the six, Hetero Biopharma, had last fortnight obtained clearance from the subject expert committee under India’s drug controller to conduct Phase-3 trials of the Russia-developed vaccine in India. Sauri Gudlavalleti, head of research and development at Dr Reddy’s Laboratories, which has secured rights to distribute Sputnik V and obtained emergency authorisation in India, said the other five may approach the Indian regulator shortly seeking the exemption.

“It is a technology transfer and not a redevelopment,” said Sauri, citing that as a reason to seek the waiver. He was responding to media queries on the sidelines of a programme on Monday to announce Dr Reddy’s arrangement with Apollo Hospitals for administering the vaccine in 35 Indian cities.

Dr Reddy’s is initially importing Sputnik V and has priced it at Rs 995.40 a dose inclusive of GST. Apollo will charge Rs 1,250 a dose, including the vaccine administration cost.

On Hetero Biopharma seeking to conduct Phase-3 trials, Sauri said: “That is one approach that has been taken. But we will have to see depending on the regulatory approach and pathway to be taken by the rest.”

Dr Reddy’s expects the other five players to approach the regulator in the next few weeks seeking the exemption, he said.

He said local trial production of Sputnik V was expected by late June or early July, to be submitted to the regulator for analysis and testing on the quality to check if it was on par with the imported vaccine.

Sputnik V was developed by Russia’s Gamaleya National Research Institute of Epidemiology and Microbiology with the backing of RDIF and was registered by the Russian health ministry as the world’s first Covid-19 vaccine based on the human adenoviral vector platform.

RDIF had entered into arrangements with Indian pharmaceutical firms Hetero Biopharma, Gland Pharma, Virchow Biotech, Panacea Biotech, Shilpa Medicare and Stelis Biopharma to produce the vaccine here.

Dr Reddy’s has conducted Phase-2 trials on 100 people in India where it proved safety and absence of adverse events and equivalence of immunogenicity. Subsequently, the Hyderabad-headquartered generic drug firm initiated Phase-3 trials on 1,500 additional volunteers to study the immunogenic response.

“Based on the 42-day immunogenic response, we were given approval for the vaccine,” said Sauri, adding: “The trial is continued for the full period of 183 days where we study the relative efficacy, the full extent of the trial.”

Dr Reddy’s “would intend to approach the Indian regulator in the next few weeks” for the single-dose Sputnik V Light to be launched in India, he said, adding: “We are awaiting all the additional submission requirements and data sets from Russia.”





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