Healthcare experts have criticised India’s decision to approve a locally developed coronavirus vaccine, warning that the process of testing the jab has not been sufficiently transparent.
Bharat Biotech’s Covaxin vaccine was cleared for emergency use on Sunday but limited data has been publicly released on its efficacy, raising concerns that proper vaccine approval guidelines have not been followed.
VG Somani, drugs controller general of India, also said the regulator had approved the vaccine made by Oxford university and AstraZeneca, which was given the green light by the UK last week.
The decision to approve both vaccines was made after “adequate examination”, said Dr Somani. The Bharat Biotech vaccine was recommended “to have more options for vaccinations, especially in case of infection by mutant strains,” he said, adding “the clinical trial ongoing within the country by the firm will continue”.
Stockpile of Bharat Biotech vaccines held by the Serum Institute of India
India is one of the world’s largest generic drug manufacturers and its companies supply large amounts of vaccines to the developing world. Bharat Biotech’s vaccine is the first locally developed candidate to be approved.
“We are extremely alarmed and shocked because this is really signifying the grant of regulatory approval without efficacy data,” said Malini Aisola, co-convener of the All India Drug Action Network, a health watchdog based in New Delhi. “The government has taken this accelerated process too far.”
Representatives for Bharat Biotech and the Indian Council of Medical Research did not respond to queries regarding data concerns.
Krishna Ella, chairman of Bharat Biotech, said the approval of the vaccine was a “proud moment for the nation and a great milestone in India’s scientific capability”.
Bharat Biotech attracted controversy in July when government officials pledged its vaccine would be launched by August 15, a fast-tracked date that was later scrapped.
India, a country of 1.4bn people, has the world’s second-highest number of total coronavirus cases behind the US, with more than 10.3m infections and almost 150,000 deaths.
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The pandemic has devastated the country’s economy after Narendra Modi, prime minister, imposed one of the harshest lockdowns in the world, disrupting the lives of millions of migrant workers and bringing business to a halt.
The decision to approve the vaccines sets the stage for a mass inoculation drive across the country. Mr Modi said on Twitter that the approval of the two vaccines was a “decisive turning point” and “reflects the will of our scientific community to fulfil the dream of a self-reliant India”.
Serum Institute of India, the world’s largest vaccine manufacturer, has built up a stockpile of 50m Covishield doses, and has said the jabs may be available privately by as early as March.
This article has been amended to make it clear that it was Bharat Biotech’s Covaxin vaccine that was cleared for emergency use on Sunday