NEW DELHI: India will likely see the Oxford-AstraZeneca vaccine approved for emergency use in the coming days as the updated data presented by the Serum Institute of India (SII) appear “satisfactory”, top government sources said.
Once the data assessment 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 presented the same data here from clinical trials in the UK and Brazil, and reviews are ongoing. The updated information shared by the Serum Institute also seems satisfactory. We hope that, based on the regulatory assessment, the vaccine will be approved in a day or two, “a senior official told TOI.
However, it is very possible that the UK will grant the emergency use authorization, as the MHRA is already reviewing the data for the vaccine developed by Oxford University and the leading pharmacist AstraZeneca.
A PTI report said the director general of the drug, Pascal Soriot, reported that the Covishield vaccine had obtained a “winning formula” for its effectiveness. Soriot’s comments were given in an interview with the Sunday Times. He added that he believes that studies will show that his company has achieved a vaccine effectiveness equal to 95% Pfizer-BioNTech and 94.5% Moderna.
“We think we have found the winning formula and how to get the effectiveness that, after two doses, is there with everyone else,” said the chief executive, adding only that the data will be published “at some point.” He also said the vaccine should be effective against the new highly transmissible variant of coronavirus.
The government intends to inoculate about 30 million “priority” populations in the first phase of the vaccination action, which is expected to take place in the first week of January and end by July at the latest. This will include healthcare and front-line workers and those at higher risk of infection, such as people over the age of 50 and others under the age of 50, but with severe comorbidities that can reduce 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 the way for the launch of a vaccine on a large scale,” the official said.
He added that as vaccine availability increases, the second phase will be launched simultaneously to expand vaccine coverage.
In addition to Covishield – for which Pune-based SII is a major production partner of AstraZeneca – two other vaccine candidates have applied for emergency use permits in India. These are Pfizer and Covaxin developed locally by Bharat Biotech in Hyderabad.
Covishield demonstrated 62% efficacy when two full doses were given to study participants, but 90% for a smaller subgroup given half, then a full dose.
In India, the Central Drug Control Organization (CDSCO) will approve the vaccine in only two full doses, as the protocol of the clinical trial approved here, as well as the linkage studies taking place in the country, involve only full doses.
The government also plans to hold a race on December 28 and 29 in four states – Punjab, Assam, Andhra Pradesh and Gujarat to assess availability for the mass vaccination exercise. Each state will plan it in two districts and, preferably, in different (five) session type settings, ie district hospital, CHC / PHC, urban location, private health unit, rural assistance, etc.
This exercise will allow the mobilization and end-to-end testing of the Covid-19 vaccination program and will verify the use of the Co-Win digital platform in the field. Approximately 50,000 medical officers have been trained across the country to ensure the smooth implementation of mega-vaccination.
Once the data assessment 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 presented the same data here from clinical trials in the UK and Brazil, and reviews are ongoing. The updated information shared by the Serum Institute also seems satisfactory. We hope that, based on the regulatory assessment, the vaccine will be approved in a day or two, “a senior official told TOI.
However, it is very possible that the UK will grant the emergency use authorization, as the MHRA is already reviewing the data for the vaccine developed by Oxford University and the leading pharmacist AstraZeneca.
A PTI report said the director general of the drug, Pascal Soriot, reported that the Covishield vaccine had obtained a “winning formula” for its effectiveness. Soriot’s comments were given in an interview with the Sunday Times. He added that he believes that studies will show that his company has achieved a vaccine effectiveness equal to 95% Pfizer-BioNTech and 94.5% Moderna.
“We think we have found the winning formula and how to get the effectiveness that, after two doses, is there with everyone else,” said the chief executive, adding only that the data will be published “at some point.” He also said the vaccine should be effective against the new highly transmissible variant of coronavirus.
The government intends to inoculate about 30 million “priority” populations in the first phase of the vaccination action, which is expected to take place in the first week of January and end by July at the latest. This will include healthcare and front-line workers and those at higher risk of infection, such as people over the age of 50 and others under the age of 50, but with severe comorbidities that can reduce 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 the way for the launch of a vaccine on a large scale,” the official said.
He added that as vaccine availability increases, the second phase will be launched simultaneously to expand vaccine coverage.
In addition to Covishield – for which Pune-based SII is a major production partner of AstraZeneca – two other vaccine candidates have applied for emergency use permits in India. These are Pfizer and Covaxin developed locally by Bharat Biotech in Hyderabad.
Covishield demonstrated 62% efficacy when two full doses were given to study participants, but 90% for a smaller subgroup given half, then a full dose.
In India, the Central Drug Control Organization (CDSCO) will approve the vaccine in only two full doses, as the protocol of the clinical trial approved here, as well as the linkage studies taking place in the country, involve only full doses.
The government also plans to hold a race on December 28 and 29 in four states – Punjab, Assam, Andhra Pradesh and Gujarat to assess availability for the mass vaccination exercise. Each state will plan it in two districts and, preferably, in different (five) session type settings, ie district hospital, CHC / PHC, urban location, private health unit, rural assistance, etc.
This exercise will allow the mobilization and end-to-end testing of the Covid-19 vaccination program and will verify the use of the Co-Win digital platform in the field. Approximately 50,000 medical officers have been trained across the country to ensure the smooth implementation of mega-vaccination.