Serum Institute submitted its three-month Phase II/III immunogenicity, safety data to India’s drug regulatory agency, spokesperson says

The first cohort of 400 participants are in the trial’s immunogenicity group, where 300 volunteers received Covishield, and the other 100 volunteers received Vaxzevria. Credits: LookerStudio/Shutterstock.com.

Serum Institute of India has provided the three-month data of its Phase II/III trial investigating its Covid-19 vaccine Covishield (SII-ChAdOx1 nCoV-19) to India’s Central Drugs Standard Control Organisation (CDSCO), a spokesperson said. The data pertains to Covishield immunogenicity compared with University of Oxford/AstraZeneca’s Vaxzevria (AZD1222) and Covishield’s safety versus placebo, he added.

On 3 February, this news service reported Serum Institute would have its three-month data release in March, followed by six-month data in June. However, the Pune, India-headquartered Serum Institute is yet to issue any communication on the 1,600-participant Phase II/III trial. The spokesperson said he did not know when the three-month data was submitted or when it should hear back from CDSCO. However, he noted, Serum Institute is in close contact with CDSCO for regular submission of data points.

The first cohort of 400 participants are in the trial’s immunogenicity group, where 300 volunteers received Covishield, and the other 100 volunteers received Vaxzevria. This portion of the trial is investigating noninferior immunogenicity between the two vaccines, with samples collected 28 days after each dose and then at certain time points for up to six months later. The second cohort of 1,200 participants were assigned in a 3:1 ratio to receive either Covishield or placebo, with a primary endpoint investigating safety.

According to the Phase II/III clinical trial registry page, the trial enrolled its first participant in August 2020. The trial completed recruitment on 31 October, according to an 11 November media release.

Covishield is one of two vaccines given Emergency Use Authorisation in India, both in the first week of January this year. Covishield authorisation was based on Phase II/III Vaxzevria protection data. Oxford/AstraZeneca have a technology transfer agreement with Serum Institute to develop the adenovirus-vectored vaccine Covishield.

The other India-authorised vaccine is Hyderabad-based Bharat Biotech’s inactivated SARS-CoV-2 vaccine, Covaxin. On 21 April, Bharat reported that its second interim analysis of its Phase III trial shows Covaxin has a vaccine efficacy of 78% based on 127 symptomatic cases.

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Reynald Castaneda is an Associate Editor for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.