India’s Drug Regulator Approves AstraZeneca / Oxford Vaccine, Country’s First: Sources



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NEW DELHI: India’s drug regulator approved on Friday (January 1) 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 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, most likely by Wednesday, said one of the sources, who declined to be identified ahead of an official announcement expected later in the day.

A representative of India’s Central Medicines Standards Control Organization (CDSCO), whose experts were meeting for the second time this week, declined to comment.

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Great Britain and Argentina have already authorized the vaccine for urgent public use.

The CDSCO is also considering emergency use authorization applications for vaccines made by Pfizer Inc with BioNTech of Germany and Bharat Biotech of India.

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

Countries with a relatively basic health infrastructure have high hopes of an injection that, unlike Pfizer’s, can be stored and transported in normal refrigeration, rather than supercooled to -70 degrees Celsius.

India has reported more than 10 million cases of COVID-19, although its infection rate has dropped significantly from a peak in mid-September. The country expects to vaccinate 300 million of its 1.35 billion people in the first six to eight months of 2021.

DOSAGE REGIME

Britain this week became the first country to authorize the AstraZeneca vaccine, ahead of other Western countries in their bid to halt a record rise in infections caused by a highly contagious form of the virus that has 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 stockpiled around 50 million doses.

Although the Indian government has yet to sign 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.

READ: India extends UK flight ban on novel coronavirus variant as it scrambles to locate previous arrivals

The SII did not immediately respond to an email request seeking comment.

Questions about the degree of effectiveness of the AstraZeneca injection have surrounded you since data released in November showed a divergence in success rates, which the developers said reflected different dosing regimens.

Britain’s drug regulator further clouded the picture this week when it said it had found an 80 percent success rate when two full doses were administered, three months apart, higher than the average the developers themselves had. found.

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