By Kaveesha Fernando
NEW DELHI, India (CWBN)_ A reputed international news agency reported yesterday (December 22) that their sources indicated that India will most likely grant emergency use authorisation for the Oxford/AstraZeneca COVID-19 vaccine by next week. This new information comes after India’s manufacturer of the vaccine, the Serum Institute of India (SII), submitted additional data requested by authorities.
An expert committee of India’s Central Drugs Standard Control Organisation (CDSCO) earlier sought additional data on the safety and efficacy of the vaccine from SII and one other Indian vaccine maker. The data requested included upgraded safety data of phase 2 and 3 of Indian clinical trials, immunogenicity data from UK and India clinical trials as well as the outcome of the UK Medicines and Healthcare products Regulatory Agency’s assessment, all of which had been provided by the SII.
In early December the SII applied for emergency use authorisation for COVISHIELD; a COVID-19 vaccine which is to be made in India following SII’s collaboration with Oxford University and pharmaceutical company AstraZeneca in order to manufacture the vaccine at select locations in India.
India is the world’s second-worst affected country by the pandemic, passing 10 million total cases of COVID-19 last weekend. The Indian government hopes to start the country’s vaccination drive by January.
However, with a new strain of COVID-19 having been discovered last week in the UK, it is not yet clear whether the current vaccines will protect against this new strain. If it does not, this could nullify much of the recent progress India has made in terms of the country’s vaccination drive.
