Mumbai: India is likely to approve Oxford-AstraZeneca’s Covid-19 vaccine for emergency use by next week after Serum Institute of India submitted additional data sought by authorities, reports said.
India could be the first country to give regulatory approval for the vaccine. Serum Institute has already stockpiled more than 50 million doses of the Oxford shot.
India, the world’s largest vaccine-making country, wants to start vaccinating its citizens next month and is also considering emergency use authorization applications for vaccines made by Pfizer Inc. and local company Bharat Biotech.
Getting the world’s second-most populous vaccines with the highest infection rates would also be a major step in the fight against the pandemic.
The AstraZeneca-Oxford shot is considered important for people in low-income countries and in hot climates because it is inexpensive, easy to transport and can be stored for a long time at normal fridge temperatures.
The Central Pharmaceutical Standards Control Organization of India (CDSCO) first reviewed three applications here on December 9 and sought more information from all companies, including the Serum Institute of India (SII), which is making AstraZeneca shots.
The world’s largest vaccine manufacturer SII has now provided all the figures. The government health advisor quoted news here on Tuesday that officials were waiting for more details of Pfizer, while a source said additional information was expected from Bharat Biotech.
Both sources said that Indian health officials were in direct contact with their British counterparts on the AstraZeneca shot and would receive “strong signals” by next week.
Expected approval after data from AstraZeneca’s late-stage trials in the UK and Brazil earlier this month showed that the vaccine had an efficacy of 62%, with participants given two full doses, but one was small. 90% gave half for the subset.
Sources said the Indian regulator is considering two full doses of the shot.
“The serum is ready,” one of the sources said. “Initially, we can get around 50 million to 60 million doses.”
India has not yet signed a vaccine supply deal with any company, but 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.
(With Reuters Inputs)