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The government has not released data on the efficacy of the vaccine.
Experts have raised concerns about India’s emergency approval of a home-made coronavirus vaccine before trials are completed.
On Sunday, Delhi approved the vaccine, known as covaxin, as well as the Oxford AstraZeneca universal vaccine, also made in India.
Prime Minister Narendra Modi described the government’s approval as a “game changer,” but health experts cautioned not to rush.
The health watchdog said he was “shocked.”
He added that there are “serious concerns arising from the absence of efficacy data” and the lack of transparency, and this “raises more questions and may not improve trust in our scientific decision-making bodies.”
The agency’s statement came after India’s general drug controller VJ Somani insisted that covaxin is “safe and provides a strong immune response.”
He added that the vaccines were approved for limited use “in the public interest as a preventive measure, to obtain more vaccination options, especially in the case of infection with new strains.”
“The vaccines are 100 percent safe,” he said, adding that side effects such as “mild fever, pain and allergies are common when each vaccine is used.”
But the Drug Control Authority said: “Understanding the scientific rationale” behind the approval of a “vaccine that was not fully studied was a puzzle.”
Dr. Gagandeep Kang, one of India’s leading medical experts, told The Times of India that she “had never seen anything like it before.”
He added: “It does not provide or publish any activity data.”
Social media users were quick to point out that approval of the vaccine before trials are completed is a concern, regardless of the safety or efficacy of the vaccine.
BBC Delhi correspondent Vikas Pandey says the vaccine was developed by the Indian pharmaceutical company Bharat Biotech, to demonstrate India’s ability to design and produce a vaccine.
But the government’s decision not to release data on the vaccine’s efficacy for review with other vaccines raised concern.
Some officials view the vaccine as a national achievement.
Modi used the vaccine approval, our correspondent says, to say that Kovaxin is a shining example of his ambitious campaign for self-reliance in India.
But experts worry that questions about the approval process don’t bode well for the campaign. And there may be deeper problems. Many believe that the government should be more transparent about the licensing process because the success of the Covid-19 vaccine program depends on the trust of the public.
The emergency mandate for the vaccine also sparked a heated debate on Indian Twitter on Sunday night between ministers and opposition leaders.
Indian Health Minister Dr. Harsh Vardan called on opposition leaders to “praise” what they did not call the country’s “prowess” in producing a vaccine locally.
Members of the Congress party, the country’s main opposition, were among those who expressed concern about the way it approved Kovaxin.
The approval comes as India prepares to vaccinate its population of more than 1.3 billion people.
Amid fears that richer countries will buy large amounts of vaccine supplies, India appears to be stockpiling vaccines.
And press reports quoted the director of the Serum Institute in India, which makes the Oxford AstraZeneca vaccine, as saying that the vaccine obtained an emergency permit on the condition that it not be exported outside of India.
Adar Bunawala added that his company, which is the world’s largest vaccine manufacturer, was also not allowed to sell the vaccine in the private market.
India plans to vaccinate some 300 million people on the priority list by August.
India recorded the second highest number of infections in the world, with more than 10.3 million confirmed cases so far. The epidemic has killed about 150,000 people.
The two vaccines approved in India on Sunday can be transported and stored at normal cooling temperature. .
