/Covid-19: Oxford vaccine may get nod in a few days – Times of India

Covid-19: Oxford vaccine may get nod in a few days – Times of India

NEW DELHI: India is likely to see the Oxford-AstraZeneca vaccine being approved for emergency use in next few days as the updated data submitted by Serum Institute of India (SII) appears “satisfactory”, top government sources said.

Once evaluation of data is complete, the regulator may not wait for the vaccine to get approval from UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

“We can take our regulatory decisions independently. The company has submitted the same data here from clinical trials in the UK and Brazil and rolling reviews are going on. The updated information shared by Serum Institute also appears satisfactory. We are hopeful that based on regulatory assessment, the vaccine will be approved in a day or two,” a senior official told TOI.

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However, it is quite possible that the UK may also meanwhile grant the emergency use authorisation as MHRA is already reviewing the data for the vaccine developed by
Oxford University and pharma major AstraZeneca.

A PTI report said the drug major’s CEO Pascal Soriot has reported the
Covishield vaccine to have achieved a “winning formula” for efficacy. Soriot’s comments were carried in an interview with the Sunday Times newspaper. He added that he believes trials will show his firm has achieved a vaccine efficacy equal to Pfizer-BioNTech at 95% and Moderna at 94.5 per cent.

“We think we have figured out the winning formula and how to get efficacy that, after two doses, is up there with everybody else,” the chief executive said, while only adding that data would be published at “some point”. He also said that the vaccine “should be” effective against the new highly transmissible variant of the coronavirus.

The government plans to inoculate around 30 crore “priority” population in the first phase of the vaccination drive that is expected to roll out in the first week of January and end latest by July. This will include healthcare and frontline workers and those at higher risk of infection such as people over 50 years of age and others below 50 years but with severe co-morbidities that can lower immunity and increase 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 way for a large scale vaccine roll out,” the official said.

He added, once the availability of vaccine increases, the second phase will be rolled out simultaneously to expand the vaccine coverage.

Apart from Covishield – for which Pune based SII is a major manufacturing partner of AstraZeneca – two other vaccine candidates have sought emergency use authorisation in India. These are Pfizer and the locally developed Covaxin by Hyderabad-based
Bharat Biotech.

Covishield has shown 62% efficacy when two full doses were given to trial participants, but 90% for a smaller sub-group given a half, then a full dose.

In India, the Central Drugs Standard Control Organisation (CDSCO) is likely to approve the vaccine only in two full doses as the clinical trial protocol approved here as well as the bridging studies being conducted in the country involves only full doses.

The government also plans to conduct dry run on December 28 and 29 in four states — Punjab, Assam, Andhra Pradesh and Gujarat to assess the readiness for the massive vaccination exercise. Each state will plan it in two districts and preferably in different (five) session type settings, that is, district hospital, CHC/PHC, urban site, private health facility, rural outreach etc.

This exercise will enable end-to-end mobilisation and testing of the Covid-19 vaccination programme and check the usage of the Co-Win digital platform in the field environment. Around 50,000 medical officers have been trained across the country to ensure smooth implementation of the mega vaccination drive

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