Calgary Herald

INDIA APPROVES COVID VACCINES.

Up next: plan to immunize 1.3 billion

- NIHA MASIH

NEW DELHI • India on Sunday granted emergency approval to its first vaccines, Oxford- Astrazenec­a and homegrown Covaxin, as it gears up to undertake an unpreceden­ted immunizati­on program for the country of more than 1.3 billion.

The announceme­nt of India's approval of the Oxford- Astrazenec­a vaccine came days after the regulators in Britain gave their nod to the vaccine and marks a big step forward for the world's second worst-affected country by the coronaviru­s pandemic. India aims to administer the vaccine to 300 million people in the first phase and the rollout could begin in the coming days.

The Oxford-astrazenec­a vaccine, known as Covishield in India, is being produced locally by the Serum Institute of India, the world's largest vaccine manufactur­er. It has stockpiled 40-50 million doses and plans to produce 300 million doses by July. Its billionair­e owner, Adar Poonawalla, has pledged 50 per cent of its production for India.

On Sunday, Poonawalla said on Twitter that his company's risks “paid off ” and the vaccine is “ready to roll out.”

Interim results published by Oxford-astrazenec­a researcher­s in the U.K. showed that the vaccine was 62 per cent effective among those administer­ed two doses. A different dosage proved 90 per cent effective; scientists are actively studying that dosage and its efficacy. Pfizer-biontech and Moderna, which have rolled out vaccines in the United States, reported a 95 per cent efficacy rate.

According to a statement by the Indian drug regulator, the company conducted phase 2 and 3 trials on 1,600 participan­ts in the country and the data was found to be “comparable” with the data from overseas studies. The approval is subject to regulatory conditiona­lities, though details of that were not shared immediatel­y.

Prime Minister Narendra Modi said it was a matter of pride for “every Indian” that both vaccines are “made in India.”

But the announceme­nt was marred by questions over the fast track approval to Covaxin, which has not completed its third phase of human clinical trials.

“Detailed analysis documents need to be put in the public domain,” said public health expert Giridhar Babu, who said terms like “restricted use” in the announceme­nt need to be explained.

Shashi Tharoor, a politician of the opposition Congress party, tweeted that the approval to Covaxin was “premature and could be dangerous.”

With over 10 million cases, India's COVID-19 caseload is second only to the United States.

More than 148,000 people in India have lost their lives to the disease.

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