NEW DELHI (Reuters) – The Indian drug regulator on Friday approved a coronavirus vaccine developed by AstraZeneca and Oxford University for emergency use, two knowledgeable sources told Reuters.
The decision frees up the roll-out of the vaccine in the world’s second-most populous country, which has the highest number of COVID-19 infections after the United States.
India wants to start administering the vaccine soon, most likely by Wednesday, said one of the sources, both of whom declined to be named pending an official announcement expected later in the day.
A representative from India’s Central Drugs Standard Control Organization (CDSCO), whose experts are meeting for the second time this week, declined to comment.
Britain and Argentina have already approved the AstraZeneca vaccine for urgent public use.
The CDSCO is also considering emergency authorization applications for vaccines made by Pfizer Inc with Germany’s BioNTech and India’s Bharat Biotech.
The AstraZeneca / Oxford vaccine is cheaper and easier to distribute than rival shots and could be a breakthrough for global immunization.
Countries with a relatively basic health infrastructure have high hopes for a recording that, unlike Pfizer’s, can be stored and transported under normal refrigeration rather than supercooled to -70 degrees Celsius (-94 Fahrenheit).
India has reported more than 10 million COVID-19 cases, although the infection rate has dropped significantly from a peak in mid-September. The country hopes to vaccinate 300 million of its 1.35 billion people in the first six to eight months of 2021.
DOSAGE REGIMES?
Britain became the first country to approve the AstraZeneca vaccine this week, ahead of other Western countries as it seeks to stop a record attempt at infections caused by a highly contagious form of the virus that has also emerged in India.
The AstraZeneca shot is manufactured in India by Serum Institute of India (SII), the world’s largest vaccine manufacturer, which has already stockpiled about 50 million doses.
While the Indian government has not yet signed a purchase agreement with SII, the company says it will focus on the home market first and then export – mainly to South Asian countries and Africa.
Questions about the degree of effectiveness of the AstraZeneca shot have been surrounding it since the data released in November showed a divergence in success rates, which, according to the developers, reflected different dosing regimens.
The UK drug regulator this week further clouded the picture when it said it had found an 80% success rate when two full doses were administered, three months apart, higher than the average the developers themselves found.
Reporting by Nigam Prusty, Shilpa Jamkhandikar and Krishna N. Das and; Editing by Neil Fullick and John Stonestreet