India’s drug regulator approves AstraZeneca COVID vaccine, country’s first – sources

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 sources with knowledge of the matter told Reuters.

The decision authorizes the deployment 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, most likely by Wednesday, said one of the sources, both of whom declined to be named before an official announcement scheduled for later today.

A representative of 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 cleared the AstraZeneca vaccine for urgent public use.

CDSCO is also considering emergency use authorization applications for vaccines manufactured by Pfizer Inc with German BioNTech and India Bharat Biotech.

Cheaper and easier to distribute than competing vaccines, the AstraZeneca / Oxford vaccine could be a game-changer for global immunization.

Countries with relatively basic health infrastructure have high hopes for an injection which, 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 cases of COVID-19, although its infection rate has declined significantly from its 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 REGIME?

Britain became the first country this week to authorize the AstraZeneca vaccine, edging out other Western countries as it seeks to stem a record outbreak of infections caused by a highly contagious form of the virus that has also surfaced in India.

The AstraZeneca vaccine is manufactured in India by the Serum Institute of India (SII), the world’s largest vaccine producer, which has already stored around 50 million doses.

Although the Indian government has yet to sign a purchase agreement with SII, the company says it will focus on the domestic market first and then on exports – mainly to countries in Southeast Asia. and Africa.

Questions about how effective AstraZeneca’s shot has been around him since data released in November showed a divergence in success rates, which the developers said reflected different dosing regimens.

The UK drugs regulator further clouded the picture this week by saying it found an 80% success rate when two full doses were given, three months apart, higher than the developers’ average. same had found.