Trial for second SII Covid vaccine begins in Pune

The clinical trial for the second Covid-19 vaccine being manufactured by Serum Institute of India (SII), developed by US-based Novavax, have started in Pune. The first three volunteers were administered a dose of the vaccine, Covovax, on Friday.

Successful completion of the trial will add to the global arsenal to fight the COVID-19 pandemic, the Indian Council of Medical Research (ICMR) said. SII has a tie-up with Novavax to manufacture and supply the vaccine in India and in low- and middle-income countries as part of the COVAX vaccine alliance countries.

ICMR has partnered with SII to conduct phase 2/3 bridging clinical trials of the vaccine. The trial is being led by ICMR – National AIDS Research Institute in Pune. The SARS-CoV-2 recombinant spike protein nanoparticle vaccine has reported efficacy of 96.4%.

The volunteers were vaccinated at the site in Pune and continue to be well, ICMR said. The trial will cover 1,600 volunteers across 19 sites in the country. As trials go on, SII has said it will start manufacturing the vaccine from April and it could see a launch by August 2021.

The company has committed to make one billion doses as per the agreement with Novavax. Around 550 million of these doses are to be supplied to COVAX under the GAVI vaccine alliance programme.

The Subject Experts Committee of the Central Drugs Standard Control Organisation (CDSCO) had on March 17 granted permission to SII to conduct Phase 2/3 bridge trial of the vaccine.