AstraZeneca vaccine, likely to get approval in India by next week

The pandemic has posed a humanitarian crisis all over the world and rolling out a vaccine at the earliest is the need of the hour for every country. India being the world's biggest vaccine-making country is considering emergency use authorization applications for vaccines made by Pfizer Inc and local company Bharat Biotech and has also thought of inoculating its citizens next month.

India is likely to approve Oxford/AstraZeneca's Coronavirus vaccine for emergency use by next week after its local manufacturer submitted additional data sought by authorities. India is world's second-most populous country with one of the highest infection rates and getting a vaccine will be a big step to combat the virus.

For lower-income countries and those in hot climates, the AstraZeneca-Oxford shot is considered vital because it is cheaper and more economical, easier to transport and has easy storage (can be stored for long periods at normal fridge temperatures).

India could be the first country to give a green light for the British drug maker’s vaccine as the British medicine regulator continues to examine data from the trials.

India's Central Drugs Standard Control Organization (CDSCO) first reviewed the three applications on Dec. 9 and more information was sought from all the companies, including Serum Institute of India (SII), which is making the AstraZeneca shots.

SII, the world's biggest vaccine manufacturer, has now provided all the data and additional information was expected from Bharat Biotech.

Indian health officials were in direct contact with their British counterparts over the AstraZeneca shot and that there were "strong indications" that an approval would come by next week.

The vaccine had efficacy of 62% for trial participants given two full doses, but 90% for a smaller sub-group given a half, then a full dose, according to data from the AstraZeneca's late-stage trials in the UK and Brazil released earlier this month. 

Although SII has already stockpiled more than 50 million doses of the AstraZeneca shot and by July plans to make a total of 400 million doses, India is yet to sign a vaccine supply deal with any company.