NEW DELHI: India is likely to see the Oxford-AstraZeneca vaccine approved for emergency use in the coming days, as updated data presented by the Serum Institute of India (SII) appears “satisfactory,” top government sources said.
Once the data assessment is complete, the regulator may not wait for the vaccine to gain approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
“We can make our regulatory decisions independently. The company has presented the same data from clinical trials in the UK and Brazil here and ongoing reviews are underway. The updated information shared by the Serum Institute also appears satisfactory. We are hopeful that, based on the regulatory evaluation, the vaccine will be approved in one or two days, “a senior official told TOI.
However, it is quite possible that the UK will also grant emergency use authorization, as MHRA is already reviewing data from the vaccine developed by the University of Oxford and major pharmaceutical company AstraZeneca.
A PTI report said the drugmaker’s CEO, Pascal Soriot, reported that the Covishield vaccine has achieved a “winning formula” of efficacy. Soriot’s comments were published in an interview with the Sunday Times newspaper. He added that he believes the trials will show that his company has achieved a vaccine efficacy equal to Pfizer-BioNTech at 95% and Moderna at 94.5%.
“We believe we have discovered the winning formula and how to get an efficacy that, after two doses, is on par with all the others,” said the CEO, adding only that the data will be released “at some point.” He also said the vaccine “should be” effective against the highly transmissible new variant of the coronavirus.
The government plans to inoculate around Rs 30 million “priority” population in the first phase of the vaccination campaign which is expected to be implemented in the first week of January and ends by July at the latest. This will include healthcare and front-line workers and those most at risk for infection, such as people over 50 and others under 50, but with severe comorbidities that can lower immunity and increase the chances of death. due to Covid-19 infection.
“In the coming weeks, we are likely to have around three vaccines licensed for emergency use, paving the way for a large-scale vaccine rollout,” the official said.
He added that once the availability of the vaccine increases, the second phase will be implemented simultaneously to expand coverage of the vaccine.
Aside from Covishield, for which Pune-based SII is a major manufacturing partner of AstraZeneca, two other candidate vaccines have applied for emergency use authorization in India. These are Pfizer and Covaxin, developed locally by Hyderabad-based Bharat Biotech.
Covishield has shown 62% efficacy when trial participants were given two full doses, but 90% for a smaller subgroup received half and then a full dose.
In India, the Central Medicines Standard 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 bridging studies being carried out in the country , they only involve full doses.
The government also plans to hold a drill 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 (five) session type settings, i.e. district hospital, CHC / PHC, urban site, private health center, rural outreach, etc.
This exercise will enable end-to-end mobilization and testing of the Covid-19 vaccination program and will test the use of the Co-Win digital platform in the field setting. Around 50,000 doctors have been trained across the country to ensure the smooth implementation of the mega vaccination campaign.
Once the data assessment is complete, the regulator may not wait for the vaccine to gain approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
“We can make our regulatory decisions independently. The company has presented the same data from clinical trials in the UK and Brazil here and ongoing reviews are underway. The updated information shared by the Serum Institute also appears satisfactory. We are hopeful that, based on the regulatory evaluation, the vaccine will be approved in one or two days, “a senior official told TOI.
However, it is quite possible that the UK will also grant emergency use authorization, as MHRA is already reviewing data from the vaccine developed by the University of Oxford and major pharmaceutical company AstraZeneca.
A PTI report said the drugmaker’s CEO, Pascal Soriot, reported that the Covishield vaccine has achieved a “winning formula” of efficacy. Soriot’s comments were published in an interview with the Sunday Times newspaper. He added that he believes the trials will show that his company has achieved a vaccine efficacy equal to Pfizer-BioNTech at 95% and Moderna at 94.5%.
“We believe we have discovered the winning formula and how to get an efficacy that, after two doses, is on par with all the others,” said the CEO, adding only that the data will be released “at some point.” He also said the vaccine “should be” effective against the highly transmissible new variant of the coronavirus.
The government plans to inoculate around Rs 30 million “priority” population in the first phase of the vaccination campaign which is expected to be implemented in the first week of January and ends by July at the latest. This will include healthcare and front-line workers and those most at risk for infection, such as people over 50 and others under 50, but with severe comorbidities that can lower immunity and increase the chances of death. due to Covid-19 infection.
“In the coming weeks, we are likely to have around three vaccines licensed for emergency use, paving the way for a large-scale vaccine rollout,” the official said.
He added that once the availability of the vaccine increases, the second phase will be implemented simultaneously to expand coverage of the vaccine.
Aside from Covishield, for which Pune-based SII is a major manufacturing partner of AstraZeneca, two other candidate vaccines have applied for emergency use authorization in India. These are Pfizer and Covaxin, developed locally by Hyderabad-based Bharat Biotech.
Covishield has shown 62% efficacy when trial participants were given two full doses, but 90% for a smaller subgroup received half and then a full dose.
In India, the Central Medicines Standard 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 bridging studies being carried out in the country , they only involve full doses.
The government also plans to hold a drill 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 (five) session type settings, i.e. district hospital, CHC / PHC, urban site, private health center, rural outreach, etc.
This exercise will enable end-to-end mobilization and testing of the Covid-19 vaccination program and will test the use of the Co-Win digital platform in the field setting. Around 50,000 doctors have been trained across the country to ensure the smooth implementation of the mega vaccination campaign.
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