- BBC World News
Experts have raised concerns about the approval in India of a locally produced coronavirus vaccine before the end of clinical trials.
Indian authorities approved the emergency use of the vaccine Cobain on Sunday, when they also gave the green light to the AstraZeneca and Oxford vaccine, which is being manufactured in the Asian country.
Prime Minister Narendra Modi referred to Cobain’s approval as a turning point in the battle against the pandemic, but health experts called the decision hasty.
The All India Drug Action Network, which tracks health issues, said it was concerned about the news.
Among other things, the organization highlighted “big concerns arising from the absence of efficacy data “as well as a lack of transparencies that “would raise more questions than answers and probably will not strengthen faith in our scientific decision-making bodies.”
The statement came after India’s comptroller general for medicines, VG Somali, insisted that Cobain is “safe and provides a strong immune response.”
Somali added that the vaccines had been approved for restricted use out of “public interest” and “in clinical trial mode, to have more vaccination options, especially in case of infection by mutant strains “.
” The vaccines are 100% safe,” Somali insisted, adding that side effects such as “mild fever, pain and allergy are common to all vaccines.”
However, the All India Drug Action Network said it could not understand the scientific logic behind the decision to approve “an incompletely studied vaccine.”
And one of India’s most eminent medical experts, Dr. Grandees Kang, told the Times of India newspaper that “he had never seen anything like it.”
” There is absolutely no no efficacy data that has been presented or published, “he added.
The emergency clearance also led to a fierce debate on Twitter between ministers and opposition leaders.
Indian Health Minister Dr. Harsh Vardhan criticized opposition leaders for not “applauding” the country’s “feat” in producing a vaccine locally.
” Of course, we will be proud if the vaccine turns out to be effective. But offering it before Phase 3 clinical trials have demonstrated its efficacy is a violation of all scientific protocols and unheard-of in the world. Patriotism is not a substitute for common sense“Opposition congresswoman Shashi Tharoor replied on her Twitter account.
And even social media users were quick to point out that approving the vaccine before trials were completed was cause for concern, regardless of how safe or effective it turns out to be.
The approval of Cobain, developed by pharmaceutical company Bharat Biotech with the support of the Medical Research Council of India, comes as India prepares to vaccinate its population of more than 1,300 million people.
And amid fears that richer countries are buying much of the vaccine supply, India appears to be stockpiling them as well.
In an interview with the Associated Press, Adar Poonawalla, whose Serum Institute of India (SII) is making the AstraZeneca and Oxford vaccine, said it had received an emergency clearance. Provided it was not exported outside of India.
Poonawalla also said his company, the world’s largest vaccine maker, was also not allowed to sell the vaccine on the private market.
This has generated worriesfrom the in neighboring countries from India, including Nepal and Bangladesh, which relied primarily on IBS to begin vaccinating their populations.
India – which has the second highest number of infections in the world, with more than 10.3 million confirmed cases to date, and nearly 150,000 deaths – plans to vaccinate about 300 million priority people before the end of August.
The two vaccines approved on Sunday can be transported and stored at normal temperatures of refrigeration.
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Eddie is an Australian news reporter with over 9 years in the industry and has published on Forbes and tech crunch.