Once the evaluation of the data is complete, the regulator cannot wait for the vaccine to receive approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA).
“We can make our regulatory decisions independently. The company has submitted the same data here from clinical studies in the UK and Brazil, and reviews are ongoing. The updated information shared by Serum Institute also seems satisfactory. We are hopeful that the vaccine will be approved based on regulatory assessment in a day or two, ”a senior official told TOI.
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However, it is very possible that the UK will also grant emergency use authorization in the meantime, as MHRA is already reviewing the data for the vaccine developed by Oxford University and pharmaceutical major AstraZeneca.
A PTI report said the drug’s CEO, Pascal Soriot, has reported that the Covishield vaccine has achieved a “winning formula” for efficacy. Soriot’s comments were taken up in an interview with the Sunday Times newspaper. He added that he believes studies will show his company has achieved vaccine efficacy equal to Pfizer-BioNTech at 95% and Moderna at 94.5 percent.
“We think we came up with the winning formula and figured out how to get an efficacy that, after two doses, is present in everyone else,” said the CEO, adding only that the data at one point in time would be published. He also said the vaccine “should” be effective against the new, highly transmissible variant of the coronavirus.
The government plans to inoculate about 30 crore “priority” population in the first phase of the vaccination action, which is expected to roll out in the first week of January and finish no later than July. This includes health and primary care workers and those at higher risk of infection, such as those over 50 and others under 50, but with severe co-morbidities that can lower immunity and increase the chance of death from Covid-19 infection .
“In the coming weeks, we will likely have about three emergency-licensed vaccines, paving the way for a large-scale introduction of vaccines,” the official said.
He added that once vaccine availability increases, the second phase will be rolled out simultaneously to expand vaccination coverage.
In addition to Covishield – for which Pune-based SII is a major AstraZeneca manufacturing partner – two other vaccine candidates in India have applied for emergency use authorization. These are Pfizer and the locally developed Covaxin by Hyderabad-based Bharat Biotech.
Covishield has shown an efficacy of 62% when two full doses were given to subjects, but 90% for a smaller subgroup who received half and then the full dose.
In India, the Central Drugs Standard Control Organization (CDSCO) will likely only approve the vaccine in two full doses, as the clinical trial protocol approved here and the bridging studies being conducted in the country are only full doses.
The government also plans to conduct a test drive in four states – Punjab, Assam, Andhra Pradesh and Gujarat on Dec. 28-29, to assess readiness for the mass vaccination exercise. Each state will schedule it in two districts and preferably in different (five) session type settings i.e. district hospital, CHC / PHC, urban site, private health facility, rural outreach etc.
This exercise will enable end-to-end mobilization and testing of the Covid-19 vaccination program and monitor the use of the Co-Win digital platform in the field environment. About 50,000 medical officers have been trained across the country to ensure the smooth implementation of the mega-vaccination