India’s medical regulator approves AstraZeneca COVID vaccine, the country’s first sources

NEW DELHI (Reuters) – India’s medical regulator on Friday approved a coronavirus vaccine developed by AstraZeneca and the University of Oxford for emergency use, two sources said with knowledge.

MANAGEMENT PHOTO: Personal Protective Equipment (PPE) employee removes vials of AstraZeneca’s COVISHIELD coronavirus (COVID-19) vaccine from a visual inspection machine in a laboratory at Serum Institute of India, Pune, India, November 30 2020. REUTERS / Francis Mascarenhas / File Photo

The decision marks the explosion of the vaccine in the second most populous country in the world to have the highest number of COVID-19 infections after the United States.

India wants to start administering the vaccine soon, probably by Wednesday, one of the sources said. Both did not want to be nominated before an official announcement expected later in the day.

A representative of the Central Drugs Standard Control Organization (CDSCO) in India, 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 German BioNTech and by India Bharat Biotech.

The cheaper and easier distribution than competitive surveys, the AstraZeneca / Oxford vaccine could be a game changer for worldwide vaccination.

Countries with a relatively basic health infrastructure are very much hoping for a shot that, unlike that of Pfizer, can be stored and transported under normal cooling, rather than cooling it 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 September. The country hopes to vaccinate 300 million of its 1.35 billion people in the first six to eight months of 2021.

DOSAGE REGIMENTS?

Britain became the first country to authorize the AstraZeneca vaccine this week, ahead of other Western countries as it seeks to stem the tide of infections caused by a highly contagious form of the virus that has also emerged in India. stop.

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

Although the Indian government has not yet signed a purchase agreement with SII, the company says it will focus on the housing market first and then export – mainly to South Asian countries and Africa.

Questions about the effectiveness of the AstraZeneca survey have surrounded it since data published in November show a variance in success rates, which according to the developers reflect different doses.

The UK’s drug regulator further clouded the picture this week when it said it 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; Edited by Neil Fullick and John Stonestreet

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