AstraZeneca’s COVID-19 vaccine is likely to get India’s approval for emergency use by next week. This comes after Serum Institute of India (SII) – its local manufacturer submitted the additional data sought by the authorities, according to the sources.
India could be the first country to show a green signal to the Oxford-AstraZeneca COVID-19 vaccine as it continues to examine the data from its trials. The country wants to start vaccinating its citizens from the next month.
The AstraZeneca vaccine shot is being considered vital for lower-income countries and those in hot climates. This is so as it is easy to transport, it cost lesser, and can be stored at normal fridge temperatures for a longer period.
Along with AstraZeneca, India is also considering the emergency use authorization applications for vaccines made by Pfizer Inc and Bharat Biotech. On December 9, India’s Central Drugs Standard Control Organization (CDSCO) reviewed the three applications and sought for more information from all the three companies, including from Serum Institute of India (SII), the manufacturer of AstraZeneca shots.
SII has provided the data sought by the authorities, according to the sources. However, the authorities waited for some more details from Pfizer and expected some more information from Bharat Biotech.
Indian health officials were in direct contact with their British counterparts over the AstraZeneca shot and that there were “strong indications” an approval would come by next week, says the source.
AstraZeneca’s expected approval by India comes after it’s late-stage trials in the UK and Brazil released earlier this month showed the vaccine had an efficacy of 62% for trial participants given two full doses, but 90% for a smaller sub-group given a half, then a full dose.
“Serum is ready,” said one of the sources. “Initially, we may get around 50 million to 60 million doses.”
India however, has not yet signed a vaccine supply deal with any company. Although SII has already stockpiled more than 50 million doses of the AstraZeneca shot and plans to make a total of 400 million doses by July.