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Covaxin: Concern over 'rushed' approval for India Covid jab

International Desk
04 Jan 2021 13:32:31 | Update: 04 Jan 2021 17:05:36
Covaxin: Concern over 'rushed' approval for India Covid jab

Experts have raised concerns over India's emergency approval of a locally-produced coronavirus vaccine before the completion of trials.

On Sunday, Delhi approved the vaccine - known as Covaxin - as well as the global AstraZeneca Oxford jab, which is also being manufactured in India.

PM Narendra Modi touted the approval as a "game-changer" but health experts warn it was rushed.

Health watchdog All India Drug Action Network said it was "shocked".

It said that there were "intense concerns arising from the absence of the efficacy data" as well a lack of transparency that would "raise more questions than answers and likely will not reinforce faith in our scientific decision making bodies".

The statement came after India's Drugs Controller General, VG Somani, insisted Covaxin was "safe and provides a robust immune response".

He added the vaccines had been approved for restricted use in the "public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains".

"The vaccines are 100% safe," he said, adding that side effects such as "mild fever, pain and allergy are common for every vaccine".

The emergency authorisation also sparked a fierce debate on Indian Twitter on Sunday night between ministers and opposition leaders.

India's health minister Dr Harsh Vardhan called out opposition leaders for failing to "applaud" the country's "prowess" in locally producing a vaccine.

Members of the main opposition Congress party, Shashi Tharoor and Jairam Ramesh, and former chief minister of Uttar Pradesh state, Akhilesh Yadav, were among those who raised concerns about the manner in which Covaxin was approved.

The approval comes as India gears up to vaccinate its population of more than 1.3 billion people. Amid fears that richer countries are buying up much of the vaccine supply, India too appears to be stockpiling vaccines.

In an interview with the Associated Press, Adar Poonawalla, whose Serum Institute of India is manufacturing the AstraZeneca Oxford vaccine, said the jab was given emergency authorisation on the condition that it would not be exported outside India.

Mr Poonawalla said his company, the world's largest vaccine maker, is also not being allowed to sell the shot in the private market.

India plans to vaccinate some 300 million people on a priority list by August.

It has recorded the second-highest number of infections in the world, with more than 10.3 million confirmed cases to date. Nearly 150,000 people have died.

Both vaccines approved on Sunday can be transported and stored at normal refrigeration temperatures.

(Source: BBC)

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