NEW DELHI: India is likely to see the Oxford-AstraZeneca vaccine approved for emergency use in the next few days, as the updated data submitted by Serum Institute of India (SII) looks “satisfactory”, government sources said .
Once the data has been evaluated, the regulator cannot wait until the vaccine is approved by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).
‘We can make our regulatory decisions independently. The company has submitted the same data here from clinical trials in the UK and Brazil, and ongoing reviews are ongoing. The updated information shared by Serum Institute also appears to be satisfactory. “We are hopeful that the vaccine will be approved on the basis of the regulatory assessment within a day or two,” a senior official told TOI.
However, it is quite possible that the UK could also in the meantime grant the authorization for emergency use, as MHRA is already reviewing the data for the vaccine developed by the University of Oxford and pharmaceutical chief AstraZeneca.
A PTI report states that drug chief executive Pascal Soriot reports that the Covishield vaccine has achieved a ‘winning formula’ for efficacy. Soriot’s comments were conveyed in an interview with the Sunday Times newspaper. He added that he believes trials will show that his company has achieved a vaccine efficiency equal to Pfizer-BioNTech at 95% and Moderna at 94.5 percent.
“We think we have determined the winning formula and how to achieve the effectiveness that, after two doses, is there in everyone else there,” the CEO said, adding only 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 vaccinate about 30 million “priority populations” in the first phase of the vaccination process, which is expected to begin in the first week of January, and the last by July. This will include healthcare and frontline workers and people at higher risk of infection, such as people older than 50 and others younger than 50, but with serious illnesses that can lower immunity and the chance of death due to Covid-19 infection can increase.
“In the coming weeks, we will probably have about three vaccines with authorization for emergency use, paving the way for a large-scale vaccination,” the official said.
He added that once the availability of vaccine increases, the second phase will be rolled out simultaneously to expand vaccine coverage.
Apart from Covishield, for which PII is based, a major manufacturing partner of AstraZeneca, two other vaccine candidates have requested an emergency permit in India. This is Pfizer and the locally developed Covaxin by Bharat Biotech, based in Hyderabad.
Covishield showed 62% efficacy when two full doses were given to trial participants, but 90% for a smaller subgroup that gave half, and then a full dose.
In India, the Central Drugs Standard Control Organization (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 conducted in the country, involve only full doses.
The government also plans to wipe out droughts in four states on December 28 and 29 – Punjab, Assam, Andhra Pradesh and Gujarat to determine readiness for the massive vaccination exercise. Each state will plan it in two districts and preferably in different (five) session types, i.e. district hospital, CHC / PHC, urban area, private health institution, rural outreach etc.
This exercise will enable end-to-end mobilization and testing of the Covid-19 vaccination program and check 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 easy vaccination
Once the data has been evaluated, the regulator cannot wait until the vaccine is approved by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).
‘We can make our regulatory decisions independently. The company has submitted the same data here from clinical trials in the UK and Brazil, and ongoing reviews are ongoing. The updated information shared by Serum Institute also appears to be satisfactory. “We are hopeful that the vaccine will be approved on the basis of the regulatory assessment within a day or two,” a senior official told TOI.
However, it is quite possible that the UK could also in the meantime grant the authorization for emergency use, as MHRA is already reviewing the data for the vaccine developed by the University of Oxford and pharmaceutical chief AstraZeneca.
A PTI report states that drug chief executive Pascal Soriot reports that the Covishield vaccine has achieved a ‘winning formula’ for efficacy. Soriot’s comments were conveyed in an interview with the Sunday Times newspaper. He added that he believes trials will show that his company has achieved a vaccine efficiency equal to Pfizer-BioNTech at 95% and Moderna at 94.5 percent.
“We think we have determined the winning formula and how to achieve the effectiveness that, after two doses, is there in everyone else there,” the CEO said, adding only 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 vaccinate about 30 million “priority populations” in the first phase of the vaccination process, which is expected to begin in the first week of January, and the last by July. This will include healthcare and frontline workers and people at higher risk of infection, such as people older than 50 and others younger than 50, but with serious illnesses that can lower immunity and the chance of death due to Covid-19 infection can increase.
“In the coming weeks, we will probably have about three vaccines with authorization for emergency use, paving the way for a large-scale vaccination,” the official said.
He added that once the availability of vaccine increases, the second phase will be rolled out simultaneously to expand vaccine coverage.
Apart from Covishield, for which PII is based, a major manufacturing partner of AstraZeneca, two other vaccine candidates have requested an emergency permit in India. This is Pfizer and the locally developed Covaxin by Bharat Biotech, based in Hyderabad.
Covishield showed 62% efficacy when two full doses were given to trial participants, but 90% for a smaller subgroup that gave half, and then a full dose.
In India, the Central Drugs Standard Control Organization (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 conducted in the country, involve only full doses.
The government also plans to wipe out droughts in four states on December 28 and 29 – Punjab, Assam, Andhra Pradesh and Gujarat to determine readiness for the massive vaccination exercise. Each state will plan it in two districts and preferably in different (five) session types, i.e. district hospital, CHC / PHC, urban area, private health institution, rural outreach etc.
This exercise will enable end-to-end mobilization and testing of the Covid-19 vaccination program and check 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 easy vaccination