Once the evaluation of the data is complete, the regulator may not wait for the vaccine to obtain approval from the UK Medicines and Health Products Regulatory Agency (MHRA).
“We can make our regulatory decisions independently. The company has presented here the same data from clinical trials conducted in the UK and Brazil and ongoing reviews are underway. The updated information shared by Serum Institute also seems satisfactory. Hopefully, based on the regulatory assessment, the vaccine will be approved in a day or two, ”a senior official told TOI.
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However, it is very possible that, in the meantime, the UK may also grant emergency use authorization, as the MHRA is already reviewing vaccine data developed by Oxford University and AstraZeneca, a leading pharmaceutical company. .
A PTI report said the general director of the main drug, Pascal Soriot, reported that the Covishield vaccine had achieved a “winning formula” of efficacy. Soriot’s comments were published in an interview with the Sunday Times. He added that he believes the trials will show that his company has achieved vaccine efficacy equal to 95% Pfizer-BioNTech and 94.5% Moderna.
“We think we’ve figured out the winning formula and how to get an effectiveness that, after two doses, is there with everyone else,” the chief executive said, though he only added that the data would be published in ” sometime “. He also said the vaccine “should be” effective against the new highly transmissible variant of the coronavirus.
The government plans to inoculate around 30 million “priority” population in the first phase of the vaccination campaign which is expected to take place in the first week of January and end in July. This will include health and front-line workers and those at higher risk of infection, such as people over 50 and others under 50, but with severe comorbidities that can reduce immunity and increase the chances of death. due to Covid-19 infection.
“In the coming weeks we are likely to have around three vaccines with emergency use authorization, paving the way for the implementation of a large-scale vaccine,” the official said.
He added that once vaccine availability increases, the second phase will be rolled out simultaneously to expand vaccine coverage.
Aside from Covishield, for which Pune-based SII is AstraZeneca’s main manufacturing partner, two other vaccine candidates have applied for emergency use authorization in India. These are Pfizer and Covaxin developed locally by Bharat Biotech, based in Hyderabad.
Covishield demonstrated 62% efficacy when two full doses were administered to trial participants, but 90% for a smaller subgroup with one-half, then a full dose.
In India, it is likely that the Central Drugs Standard Control Organization (CDSCO) will only approve the vaccine in two full doses, as the clinical trial protocol approved here, as well as the connection studies being conducted in the country, they include only full doses.
The government also plans to conduct a dry test on December 28 and 29 in four states: Punjab, Assam, Andhra Pradesh and Gujarat to assess readiness for the massive vaccination exercise. Each state will plan it in two districts and preferably in different (five) session type configurations, i.e. district hospital, CHC / PHC, urban site, private health center, rural outreach, etc.
This exercise will allow the mobilization and end-to-end testing of the Covid-19 vaccination program and will test the use of the Co-Win digital platform in the field environment. Around 50,000 medical agents have been trained across the country to ensure a smooth implementation of the mega vaccination action