SII to seek DCGI nod for 2 full-dose Covishield regimen

Serum Institute of India will ask approval for Covishield’s two full-dose regimen: Report

SII is developing Covishield in collaboration with Oxford University

Credit: Reuters

Pune-based Serum Institute of India (SII) is asking the health regulators’ approval for a two full-dose regimen for its Covid-19 vaccine which it is developing with Oxford University, according to a report by Business Standard.

The University informed SII that this regimen showed a better immune response in patients observed in its early trials, than the earlier regimen which was one full dose followed by a half-dose of its vaccine Covishield. A single full dose showed even lower efficiency.

Executive Director of SII Suresh Jadhav said the institute, which is the biggest vaccine maker in India, is seeking approval from the Drug Controller General of India (DCGI) for the two full-dose prescriptions.

Last week, the Subject Expert Committee, appointed to study the proposals of vaccine makers for emergency use authorisation, asked for more data for Covishield from the firm. The companies have already submitted data from clinical trials conducted on 1,600 people in India.

Jadhav explained that one half-dose, one full-dose regimen was not planned. “It happened because one analytical method used to determine the potency was changed... The product that was formulated had half the antigen. In India, we have tested with two full-doses," he is quoted as saying by the publication.

The AstraZeneca-Oxford vaccine maker had said last month that the lowest efficacy results it had got from its vaccine were 60-70%, which is also viable enough against the vaccine.

On Friday, India crossed the 1-crore mark in its tally of total Covid-19 cases. The Ministry of Family Health and Welfare also posted a FAQ regarding vaccination drives in India, if and when a vaccine gets approved.