The Indian drug regulatory authority has instructed Dr Reddy’s Laboratories to conduct the phase II/III clinical trial in the country with proper monitoring of humoral and cell-mediated immune response of Sputnik-V, the Russian COVID-19 vaccine. This has evinced praise and appreciation for industry experts and observers.

Dr Babu KV,  Founder Member, ADEH said, “The credibility of scientific medicine is still very high only because the views of the experts based on scientific methods, which are not superseded by political decisions, even now in India. Therefore, we appreciate the decision of the experts, indicating that there are no short cuts in vaccine trials and requisite protocols of COVID–19 vaccines should be followed properly.”

Bejon Misra, Founder Director, Patients Safety and Access Initiative opined, “As a patient, I will always encourage DCGI and his team at CDSCO to assure that no element of doubt is left unanswered in the process of the critical clinical trial. We have a very robust regulation in place, which should be fully utilised and no compromise should be made in terms of bringing any short cut to the process to encourage Commerce. Patients’ health is paramount, so we expect and we acknowledge that all clinical trials should commence from phase I clinical trial onwards.”

“I fully support the CDSCO decision to not do the phase III clinical trial of Sputnik. The paper on phase I and II trial results of the Sputnik does not inspire confidence as noted by the CDSCO. Russia should first launch the phase III trial in Russia before approaching India. No Indian company should help Russia to do a clinical trial in India that they have refrained from doing in their own country,” expressed Amar Jesani, Editor, Indian Journal of Medical Ethics.

Elaborating on the need for conducting phase II and III trials in India, Dr Kiran Marthak, Director, Veeda Clinical Research Worldwide informed, “There are 321 vaccine studies are going on. Out of which 27 are in phase I/ phase II and six are in phase III. Sputnik vaccine, which is the Russian vaccine is a lyophilised product recommended to be administered two times at an interval of 15 days. It is based on the adenovirus vaccine with Ad5 and Ad26. In Russia, for the phase I study in 300 subjects, 14 per cent had mild adverse events. And for the phase III study, they have plans to enrol 40,000 subjects.”

He continued, “In India, as we know Dr Reddy’s Laboratories has tied up with a Russian company. And the DCGI has asked the company to generate some safety and efficacy data (Phase II/ Phase III)  in Indian population to understand its behaviour in India, which is very essential considering that if the vaccine comes in the market millions of people will be administered with it for prevention of coronavirus  infection.”

The developments so far

In a Subject Expert Committee (SEC) meeting held on October 5, 2020, to examine COVID-19 related proposals which are under accelerated approval process, some recommendations were presented by an expert panel of the Central Drugs Standard Control Organisation (CDSCO). During the meeting, experts informed that Dr Reddy’s Laboratories had presented phase III clinical trial protocol along with overseas phase I/II clinical trial and non-clinical toxicity data before the committee.

However, based on the submission by the company, the committee noted that the safety and immunogenicity data from the overseas phase I/II studies are small and there is no data available on Indian subjects.

Therefore, it recommended that Dr Reddy’s Laboratories should follow regulatory requirements and conduct phase II/III clinical trials in the country with proper monitoring for humoral and cell-mediated immune response. And accordingly, the company should submit the protocol for consideration of the committee.

Besides, the expert panel has also recommended that Dr Reddy’s Laboratories should submit stability data as per usage conditions.

Last month, Dr Reddy’s Laboratories entered into the partnership with the Russian Direct Investment Fund (RDIF), which is marketing the Sputnik V. The partnership is to run the clinical trials and distribute the vaccine in India.

Express Pharma contacted Dr Reddy’s Laboratories’ spokesperson about initiating phase II and III clinical trials in India, but the company did not choose to comment on the development. Dr Eswara Reddy, Joint Drug Controller General of India informed that even the CDSCO office doesn’t have information yet about the company’s progress on this development.