NEW DELHI: India is likely to approve the Oxford / AstraZeneca coronavirus vaccine for emergency use next week after its local manufacturer submitted additional data requested by authorities, two sources with knowledge of the matter told Reuters on Tuesday.
This could be the first country to give a regulatory green light to the British drugmaker’s vaccine, as the British medicine regulator continues to examine the data from the trials.
India, the world’s largest vaccine-producing country, wants to start inoculating its citizens next month and is also considering emergency use authorization applications for vaccines made by Pfizer Inc and local company Bharat Biotech.
Bringing vaccines to the second most populous country in the world with one of the highest infection rates will also be a big step in the battle against the pandemic.
AstraZeneca-Oxford injection is considered vital for low-income countries and those in hot climates because it is cheaper, easier to transport, and can be stored for long periods at normal refrigerator temperatures.
The Central Medicines Control Organization of India (CDSCO) first reviewed the three applications on December 9 here and sought more information from all companies, including the Serum Institute of India (SII), which is manufacturing the AstraZeneca injections.
SII, the world’s largest vaccine maker, has provided all the data, the two sources said. Authorities were still awaiting more details from Pfizer, a government health adviser said here at a press conference on Tuesday, while one of the sources said additional information was expected from Bharat Biotech.
Both sources said that Indian health officials were in direct contact with their British counterparts about the AstraZeneca injection and that there were “strong indications” that approval would come next week.
The expected approval comes after data from AstraZeneca’s late-stage trials in the UK and Brazil published earlier this month showed the vaccine was 62% effective for trial participants who received two full doses. , but 90% for a smaller subgroup that received half. then a full dose.
The Indian regulator is only considering the full two-dose regimen of the injection even though it shows a lower success rate, the sources said.
“The serum is ready,” said one of the sources. “Initially, we can get between 50 and 60 million doses.”
The sources declined to be identified as deliberations were ongoing and the schedule could change.
CDSCO chief VG Somani did not immediately respond to a request for comment. Bharat Biotech and Pfizer declined to comment, while SII did not immediately respond to an email seeking comment.
India has not yet signed a vaccine supply agreement with any company, but IBS has already stockpiled more than 50 million doses of the AstraZeneca injection and plans to make a total of 400 million doses by July.
This could be the first country to give a regulatory green light to the British drugmaker’s vaccine, as the British medicine regulator continues to examine the data from the trials.
India, the world’s largest vaccine-producing country, wants to start inoculating its citizens next month and is also considering emergency use authorization applications for vaccines made by Pfizer Inc and local company Bharat Biotech.
Bringing vaccines to the second most populous country in the world with one of the highest infection rates will also be a big step in the battle against the pandemic.
AstraZeneca-Oxford injection is considered vital for low-income countries and those in hot climates because it is cheaper, easier to transport, and can be stored for long periods at normal refrigerator temperatures.
The Central Medicines Control Organization of India (CDSCO) first reviewed the three applications on December 9 here and sought more information from all companies, including the Serum Institute of India (SII), which is manufacturing the AstraZeneca injections.
SII, the world’s largest vaccine maker, has provided all the data, the two sources said. Authorities were still awaiting more details from Pfizer, a government health adviser said here at a press conference on Tuesday, while one of the sources said additional information was expected from Bharat Biotech.
Both sources said that Indian health officials were in direct contact with their British counterparts about the AstraZeneca injection and that there were “strong indications” that approval would come next week.
The expected approval comes after data from AstraZeneca’s late-stage trials in the UK and Brazil published earlier this month showed the vaccine was 62% effective for trial participants who received two full doses. , but 90% for a smaller subgroup that received half. then a full dose.
The Indian regulator is only considering the full two-dose regimen of the injection even though it shows a lower success rate, the sources said.
“The serum is ready,” said one of the sources. “Initially, we can get between 50 and 60 million doses.”
The sources declined to be identified as deliberations were ongoing and the schedule could change.
CDSCO chief VG Somani did not immediately respond to a request for comment. Bharat Biotech and Pfizer declined to comment, while SII did not immediately respond to an email seeking comment.
India has not yet signed a vaccine supply agreement with any company, but IBS has already stockpiled more than 50 million doses of the AstraZeneca injection and plans to make a total of 400 million doses by July.
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