NEW DELHI (Reuters) – India’s drug regulator on Friday approved a coronavirus vaccine developed by AstraZeneca and the University of Oxford for emergency use, two knowledgeable sources told Reuters.
The decision clarifies the launch of the vaccine in the second most populous country in the world, which, after the United States, has the highest number of COVID-19 infections.
India wants to start administering the vaccine soon, probably on Wednesday, said one of the sources, both of whom declined to be identified before an official announcement scheduled for the end of the day.
A representative of India’s Central Drug Control Organization (CDSCO), whose experts are meeting for the second time this week, declined to comment.
Great Britain and Argentina have already authorized the AstraZeneca vaccine for urgent public use.
CDSCO is also considering applications for emergency use authorization for vaccines made by Pfizer Inc with BioNTech in Germany and Bharat Biotech in India.
Cheaper and easier to distribute than rival vaccines, the AstraZeneca / Oxford vaccine can change the game for global immunization.
Countries with relatively basic health infrastructure have high hopes for an injection that, unlike Pfizer, can be stored and transported under normal refrigeration, rather than super-cooled to -70 degrees Celsius (-94 Fahrenheit).
India has reported more than 10 million cases of COVID-19, although its infection rate has dropped significantly since the mid-September peak. The country expects to inoculate 300 million of its 1.35 billion inhabitants in the first six to eight months of 2021.
DOSAGE REGIME?
Britain became the first country this week to authorize the AstraZeneca vaccine, ahead of other Western countries as it seeks to contain a record increase in infections caused by a highly contagious form of the virus that also appeared in India.
The AstraZeneca injection is being manufactured in India by the Serum Institute of India (SII), the world’s largest producer of vaccines, which has already stocked around 50 million doses.
Although the Indian government has not yet signed a purchase agreement with SII, the company says it will focus first on the domestic market and then on exports – mainly to countries in South Asia and Africa.
Doubts about the effectiveness of the AstraZeneca injection have surrounded him since the data published in November showed a divergence in success rates, which the developers said reflected different dosing regimens.
Britain’s drug regulator further blurred the picture this week when it said it had found an 80% success rate when two full doses were administered, three months apart, higher than the average that the developers themselves they had found.
Reporting by Nigam Prusty, Shilpa Jamkhandikar and Krishna N. Das e; Editing by Neil Fullick and John Stonestreet