NEW DELHI: India is likely to see the Oxford-AstraZeneca vaccine being approved for emergency use in the coming days, as the updated data presented by the Serum Institute of India (SII) looks “satisfactory”, government sources said.
Once the data evaluation is complete, the regulator cannot expect the vaccine to obtain approval from the UK Medicines and Health Products Regulatory Agency (MHRA).
“We can make our regulatory decisions independently. The company presented here the same data from clinical trials in the UK and Brazil and ongoing reviews are ongoing. The updated information shared by the Serum Institute also looks satisfactory. We hope that, based on the regulatory assessment, the vaccine will be approved in a day or two, ”said a senior official to TOI.
However, it is quite possible that the UK will also grant emergency use authorization, as the MHRA is already reviewing data for the vaccine developed by Oxford University and the pharmaceutical company AstraZeneca.
A PTI report said that Pascal Soriot, CEO of the drug company, reported that the Covishield vaccine achieved a “winning formula” in terms of effectiveness. Soriot’s comments were published in an interview with the Sunday Times. He added that he believes the tests will show that his company achieved a vaccine effectiveness equal to Pfizer-BioNTech by 95% and Moderna by 94.5%.
“We think we have found the winning formula and how to achieve effectiveness that, after two doses, is up to everyone,” said the chief executive, while only adding that the 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 about 30 crore of the “priority” population in the first phase of the vaccination campaign, which should take place in the first week of January and end in July. This will include healthcare and front-line professionals and those most at 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, it is likely that we will have about three vaccines with emergency use authorization, paving the way for the launch of a large-scale vaccine,” said the official.
He added that as soon as vaccine availability increases, the second phase will be launched simultaneously to expand vaccine coverage.
In addition to Covishield – for which the Pune-based SII is an important manufacturing partner for AstraZeneca – two other vaccine candidates have sought authorization for emergency use in India. They are Pfizer and Covaxin developed locally by Bharat Biotech, based in Hyderabad.
Covishield demonstrated 62% effectiveness when two full doses were administered to study participants, but 90% for a smaller subgroup that received half and then a full dose.
In India, the Central Drug Control Organization (CDSCO) is likely to approve the vaccine in only two full doses, as the clinical trial protocol approved here, as well as the transition studies conducted in the country, involve only full doses.
The government also plans to run a simulation on December 28 and 29 in four states – Punjab, Assam, Andhra Pradesh and Gujarat to assess readiness for the mass vaccination exercise. Each state will plan it in two districts and preferably in different session type configurations (five), that is, district hospital, CHC / PHC, urban location, private health unit, rural reach, etc.
This exercise will allow end-to-end mobilization and testing of the Covid-19 vaccination program and will verify the use of the Co-Win digital platform in the field environment. About 50,000 doctors were trained across the country to ensure smooth implementation of the mega vaccination campaign
Once the data evaluation is complete, the regulator cannot expect the vaccine to obtain approval from the UK Medicines and Health Products Regulatory Agency (MHRA).
“We can make our regulatory decisions independently. The company presented here the same data from clinical trials in the UK and Brazil and ongoing reviews are ongoing. The updated information shared by the Serum Institute also looks satisfactory. We hope that, based on the regulatory assessment, the vaccine will be approved in a day or two, ”said a senior official to TOI.
However, it is quite possible that the UK will also grant emergency use authorization, as the MHRA is already reviewing data for the vaccine developed by Oxford University and the pharmaceutical company AstraZeneca.
A PTI report said that Pascal Soriot, CEO of the drug company, reported that the Covishield vaccine achieved a “winning formula” in terms of effectiveness. Soriot’s comments were published in an interview with the Sunday Times. He added that he believes the tests will show that his company achieved a vaccine effectiveness equal to Pfizer-BioNTech by 95% and Moderna by 94.5%.
“We think we have found the winning formula and how to achieve effectiveness that, after two doses, is up to everyone,” said the chief executive, while only adding that the 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 about 30 crore of the “priority” population in the first phase of the vaccination campaign, which should take place in the first week of January and end in July. This will include healthcare and front-line professionals and those most at 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, it is likely that we will have about three vaccines with emergency use authorization, paving the way for the launch of a large-scale vaccine,” said the official.
He added that as soon as vaccine availability increases, the second phase will be launched simultaneously to expand vaccine coverage.
In addition to Covishield – for which the Pune-based SII is an important manufacturing partner for AstraZeneca – two other vaccine candidates have sought authorization for emergency use in India. They are Pfizer and Covaxin developed locally by Bharat Biotech, based in Hyderabad.
Covishield demonstrated 62% effectiveness when two full doses were administered to study participants, but 90% for a smaller subgroup that received half and then a full dose.
In India, the Central Drug Control Organization (CDSCO) is likely to approve the vaccine in only two full doses, as the clinical trial protocol approved here, as well as the transition studies conducted in the country, involve only full doses.
The government also plans to run a simulation on December 28 and 29 in four states – Punjab, Assam, Andhra Pradesh and Gujarat to assess readiness for the mass vaccination exercise. Each state will plan it in two districts and preferably in different session type configurations (five), that is, district hospital, CHC / PHC, urban location, private health unit, rural reach, etc.
This exercise will allow end-to-end mobilization and testing of the Covid-19 vaccination program and will verify the use of the Co-Win digital platform in the field environment. About 50,000 doctors were trained across the country to ensure smooth implementation of the mega vaccination campaign