Indian regulator approves AstraZeneca COVID vaccine, the country’s first source

NEW DELHI (Reuters) – India’s drug regulator approved a coronavirus vaccine developed by AstraZeneca and Oxford University for emergency use on Friday, two sources familiar with the matter told Reuters.

PHOTO FILE: An employee in personal protective equipment (PPE) removes the bottles of the vaccine AstraZeneca COVISHIELD, coronavirus disease (COVID-19) from a visual inspection device inside a laboratory at the Serum Institute of India, Pune, India, 30 November 2020. REUTERS / Francis Mascarenhas / Photo File

The decision eliminates 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, one source said, with both refusing to be named before an official announcement expected later that day.

A representative of the Central Organization for the Control of Drug Standards in India (CDSCO), whose experts are meeting for the second time this week, declined to comment.

The United Kingdom and Argentina have already authorized the AstraZeneca vaccine for urgent public use.

CDSCO is also considering emergency authorization applications for vaccines made by Pfizer Inc. with German company BioNTech and India’s Bharat Biotech.

Cheaper and easier to distribute than rival photos, the AstraZeneca / Oxford vaccine could change the game for global immunization.

Countries with relatively basic health infrastructure have high hopes for a blow that, unlike Pfizer, 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 dropped significantly since its peak in mid-September. The country hopes to inoculate 300 million of the 1.35 billion people in the first six to eight months of 2021.

DOSAGE REGIME?

The UK became the first country to authorize the AstraZeneca vaccine this week, advancing ahead of other Western countries as it tries to stop a record wave of infections caused by a highly contagious form of the virus that has also appeared in India.

The AstraZeneca shot is manufactured in India by the Serum Institute of India (SII), the world’s largest vaccine manufacturer, which has already stockpiled about 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 South Asian and African countries.

Questions about the effectiveness of the AstraZeneca hit surrounded him, as data released in November showed a divergence in success rates, which developers said reflected in different dosing schemes.

The UK drug regulator has tarnished its image this week when it said it found an 80% success rate when two full doses were given three months apart, higher than the average they found. -the developers themselves.

Reported by Nigam Prusty, Shilpa Jamkhandikar and Krishna N. Das and; Editing by Neil Fullick and John Stonestreet

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