Covishield’s response same as UK version of Oxford-az jab: Study

Covishield, the locally manufactured version of Oxford-astrazeneca (AZD1222) vaccine against the coronavirus disease (Covid-19), has similar immune response as compared to AZD1222, and acceptable safety profile, according to the bridging phase 2/3 trial carried out in India. The trial’s results are part of a pre-print study yet to be peer reviewed.

Covishield (SII-CHADOX1 ncov-19), locally manufactured by Pune based Serum Institute of India (SII) following technology transfer from Astrazeneca, was evaluated in a phase 2/3 immuno-bridging study in India.

“SII-CHADOX1 ncov-19 has a non-inferior immune response compared to AZD1222 and an acceptable safety/reactogenicity profile,” said the the phase 2/3, Observer-blind, Randomised, Controlled Study.

The Oxford-astrazeneca vaccine is sold as Vaxzevria in Western

markets. Between August 25 and October 31, 2020, 1601 participants were enrolled for the study, of which 401 were in the immunogenicity or reactogenicity cohort and 1200 in the safety cohort. “After two doses of SIICHADOX1 ncov-19 or AZD1222, seroconversion rates for antispike IGG antibodies were 98% and 98·9%, respectively…,” said researchers.

Drugs Controller General of India granted emergency use authorisation to Covishield on January 3. As per Union health ministry’s provisional data till 7pm on Monday, 697 million doses of the vaccine have so far been administered.

SII submitted the drugs regulator safety, immunogenicity and efficacy data generated on 23,745 participants aged 18 years and older from overseas studies. The overall efficacy was found to be 70.42%. The company also submitted data from the bridging trials to the national drugs regulator that was not made public then.