UK's approval to Oxford-AstraZeneca vaccine paves way for India
The United Kingdom on Wednesday approved the vaccine developed by Oxford University and the British-Swedish pharmaceutical company AstraZeneca, giving the vaccine an endorsement that will likely be considered by Indian drug regulators. India is reportedly just days away from approving a COVID-19 vaccine, and Oxford-AstraZeneca's shot (labeled 'Covishield' in India) is a frontrunner. Here are more details.
The potential vaccine consists of the replication-deficient chimpanzee viral vector (ChAdOx1) based on a weakened version of a common cold virus (adenovirus) containing the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the spike protein produced triggers an immune response that offers protection against future SARS-CoV-2 infections. The vaccine has been found to have an average efficacy of 70%.
After the vaccine was approved in the UK, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) held a meeting on Wednesday to review emergency use authorization (EUA) applications. The Serum Institute of India (SII)—which is developing Covishield in India under a partnership with Oxford University and AstraZeneca—has applied for EUA, along with Pfizer India and Bharat Biotech.
The panel is yet to reach a decision and a further meeting will be convened on Friday. A statement said, "...Further time was requested on behalf of Pfizer. The additional data and information presented by SII and Bharat Biotech Pvt. Ltd. was perused and analyzed by the SEC. The analysis of the additional data and information is going on."
The SEC decision is likely to consider the approval by the UK's Medicines and Healthcare Products Regulatory Agency (MHRA). The Director of All India Institute of Medical Sciences (AIIMS), Delhi, Dr. Randeep Guleria, said Wednesday that India will soon get a vaccine.
Dr. Guleria told ANI, "This is very good news that AstraZeneca got approval for its vaccine by UK regulatory authorities. They have robust data, and in India, the same vaccine is being developed by the Serum Institute of India." "Once the data is shown to the regulatory authority, we should get approval for the vaccine in the country within a few days," he added.
As of Thursday morning, India reported a total of 1,02,66,674 COVID-19 cases, with 21,821 new cases being recorded over a 24-hour period. The total cases include 2,57,656 active cases, while 98,60,280 patients have recovered. The death toll has risen to 1,48,738 with 299 fresh fatalities. India is the world's second worst-hit country in the outbreak after the United States.