An expert panel under the Central Drugs Standard Control Organisation (CDSCO) has recommended Serum Institute’s Covishield, paving the way for the roll-out of the first COVID-19 vaccine in India, THE WEEK has learnt. The recommendations for the vaccine are for two full doses of the vaccine, given 28 days apart.
Further details on the expert panel’s view on the vaccines by Bharat Biotech and Pfizer are awaited.
The recommendation of the subject expert panel will now be routed to the Drug Controller General of India (DCGI) who will grant the final approval. The DCGI’s approval is expected soon. Following the approval, the actual rollout of the vaccine would take another 6-7 days, a government source said. A dry run of the vaccine shall take place in the country tomorrow.
Aside from the expert committee’s deliberations, health activists have raised concerns about the efficacy data of the vaccine. Experts have reviewed efficacy data from the UK and Brazil trials, alongside the safety and immunogenicity data of the Indian trial.
In a letter addressed to Dr V.K. Paul, chairperson of the national expert group for vaccine administration, the All India Drug Action Network has raised several concerns after comparing the data from several trials.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) assessed the efficacy of the vaccine based on 131 events in 11,636 people (94 per cent of whom were under 65 years of age) merging data across two trials from the UK and Brazil. In these data, there are wide variations in the duration of the interval between dosing (ranging from 4 weeks-26 weeks) and also differences in the strength of the vaccine doses. There were also differences in the trial designs of the UK and Brazil trials, health activists have pointed out.
“There are important differences between the SII’s Indian trial and the foreign trials of the AstraZeneca/Oxford vaccine. We are unclear if SII has submitted the interim safety and immunogenicity data for all participants which is critical for the assessment of the vaccine candidate in an Indian population and the purpose of the bridging study,” the group has stated in the letter. For the two full doses given 28 days apart, there is “no corresponding efficacy analysis” reported for such a dosing regimen in the published data of the UK and Brazil trials for the AstraZeneca/Oxford vaccine, they say.
An efficacy analysis for two standard doses at an interval of less than 6 weeks shows efficacy of 53.4 per cent, based on analysis of 28 cases (in 3,400 persons aged 18 – 55 years) in the UK and Brazil trials. Owing to the small sample, this efficacy estimate may not be particularly robust. “But, it would still fail to meet the criteria set out by the WHO for evaluation of COVID-19 vaccines for either prequalification or for Emergency Use Listing and draft guidelines of the CDSCO,” AIDAN pointed out.