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Tuesday, June 15, 2021

Covovax Phase 3 trial to proceed without placebo as DCGI gives nod to revised protocol

Under a placebo-controlled trial, some volunteers are administered the drug while some are given a placebo to help researchers compare and understand the efficacy of the medication.

Written by Anuradha Mascarenhas | Pune |
Updated: June 6, 2021 8:08:37 am
Phase 3 clinical trials of Covavax may begin by mid-JuneThe DGCI has approved the revision in protocol for conducting Phase 3 clinical trials of Covovax, the second Covid-19 vaccine candidate being manufactured at Pune-based Serum Institute of India. (Representational Image)

The Drugs Controller General of India (DCGI) has approved the revision in the protocol for conducting the Phase 3 clinical trial of Covovax, the second Covid-19 vaccine candidate being manufactured at Pune-based Serum Institute of India (SII), allowing the doing away of the placebo arm of the trial.

The trial would see Covovax, the vaccine SII is manufacturing in partnership with US vaccine maker Novavax, being tested on 1400 volunteers above 18 years of age across 20 sites in the country. Four of these sites – Sahyadri Hospital, Noble Hospital, DY Patil Hospital, and KEM-Vadu – are in Pune.

Under a placebo-controlled trial, some volunteers are administered the drug while some are given a placebo to help researchers compare and understand the efficacy of the medication.

The Indian Council of Medical Research (ICMR) and SII are jointly performing a phase 2/3 observer-blind randomised controlled study to determine the safety and immunogenicity of Covovax, a SARS-CoV-2 recombinant spike (SARS-CoV-2rS) protein nanoparticle vaccine, with Matrix-M1 adjuvant in Indian adults.

The initial safety data collected from 200 participants was presented to the Data Safety Monitoring Board (DSMB) following the recommendations of which the initiation of Phase 3 part of the study was permitted.

Dr Abhijit Kadam, Scientist C, Coordinating Principal Investigator from ICMR–NARI, said that tentatively the Phase 3 trial should begin by mid June. Researchers across the 20 sites earmarked for the purpose said the process of recruiting volunteers for the larger Phase 3 trial will begin soon.

Last year, Novavax had announced a license agreement with SII for the development and commercialisation of NVX-COV2373, its Covid-19 vaccine candidate, in low and middle-income countries, and India.

Subsequently, Novavax published results of the UK Phase 3 study, which had assessed the efficacy of the vaccine NVX-COV2373 during a period with high transmission, and with the UK variant strain circulating widely. The results found that the vaccine was 89.7 per cent effective in preventing Covid-19 infection.

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