CDSCO asks Biological E, Dr Reddy’s to review covid-19 vaccine trial protocols

NEW DELHI : An expert panel of the Central Drugs Standards Control Organization (CDSCO) on Thursday asked Dr Reddy’s Laboratories Ltd and Biological E Ltd to review the clinical trial protocols they had submitted for their respective covid-19 vaccine candidates.

While Dr Reddy’s Laboratories plans to conduct phase 3 clinical trials for the Sputnik V vaccine candidate, jointly developed by Russian Direct Investment Fund (RDIF) and Gamaleya Research Institute of Epidemiology and Microbiology, Biological E is conducting a trial of the recombinant protein vaccine developed by US’ Baylor College of Medicine.

The subject expert committee (SEC) of the CDSCO in a meeting on Monday had said that Dr Reddy’s should follow the regulatory requirements and conduct a seamless Phase 2 and 3 clinical trial in India, instead of just a phase 3 study, with proper monitoring for humoral and cell mediated immune response. While humoral immune response includes immunity provided by antibodies, cell-mediated response refers to that provided by T-cells.

The panel sought a phase 2 and 3 trial because the safety and immunogenicity data in overseas phase I/II studies was small and there was no data available on Indian subjects.

For Biological E, the regulatory panel said that the company should conduct phase 1 and 2 trials along with animal challenge studies, which refers to experiments where an animal that has been given a vaccine dose is later given, or challenged with, the virus



to determine whether the vaccine candidate provides immunity.

The panel has also asked the company to conduct a safety study with varying dosage in phase 1 before proceeding to phase 2.

“Firm should carry out ascending dose safety study starting with 15mcg dose, 25 mcg dose & 50mcg dose before proceeding to Phase II study," minutes of the SEC meeting said.

Spokespersons for Biological E and Dr Reddy’s declined to comment on the SEC decision, and queries sent to RDIF remained unanswered at the time of publishing.

The reviews are a standard process that vaccine developers have to go through for finetuning their protocols before receiving regulatory approval.

Last month, Dr Reddy’s and the RDIF had announced a partnership to conduct clinical trials for the Russian Sputnik V vaccine in India. As per the pact, Dr Reddy's will also distribute around 100 million doses of the vaccine in India after Phase 3 human trials are completed, and approvals granted by Indian regulators. However, the Hyderabad-based drugmaker will not manufacture the vaccine.

Biological E in August signed an agreement with Baylor College of Medicine, wherein the Indian company would be given a license to the recombinant protein covid-19 vaccine candidate, with Biological E conducting clinical trials and manufacturing it. Biological E also has a pact with Johnson and Johnson for manufacturing the US firm’s vaccine candidate.