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

Experts voiced their concerns over India's emergency approval of a locally-produced coronavirus vaccine before completing trials.

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

PM Narendra Modi praised 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 provided a robust immune response."

He added the vaccines had been approved for restricted use in "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."

However, the All India Drug Action Network said it was "baffled to understand the scientific logic" to approve "an incompletely studied vaccine."

One of India's most eminent medical experts, Dr. Gagandeep Kang, told the Times of India newspaper that she had "not seen anything like this before." She added that "there are no efficacy data that has been presented or published."

Even social media users hustled to point out that approving the vaccine before trials were complete was a matter of concern irrespective of how safe or effective the vaccine eventually turned out to be.

Many scientists and opposition politicians have raised questions over what they say is the hasty authorization of Covaxin, an Indian-made vaccine by local pharmaceutical firm Bharat Biotech.

The company has developed the vaccine with the state-run Indian Council of Medical Research - and the effort has been touted as an example of India's might in vaccine development and production.

Regulators say the vaccine is safe and effective. The firm says phase 1 and phase 2 trials have yielded promising results.

But scientists say that the government's decision to not release data on the vaccine's efficacy for peer review is worrying.

Prime Minister Narendra Modi has welcomed the approval, noting Covaxin is a shining example of his aspiring Atmnirbhar (self-reliance) India campaign.