Daily US Times: Experts in India have raised concerns over India’s emergency approval of a locally-produced Covid-19 vaccine before the completion of trials.
On Sunday, the Indian government approved the Covid-19 vaccine – known as Covaxin – as well as the global Oxford jab, which is also being manufactured in India.
Prime Minister Narendra Modi touted the approval as a “game changer” but health experts warn it was rushed.
In response to the approval, 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 VG Somani, India’s Drugs Controller General, 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”.
He said: “The vaccines are 100% safe,” adding that side effects of the vaccine 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”.
It also says the hypothesis that the vaccine might be useful against the coronavirus was not supported by data from the trials.
Dr Gagandeep Kang, one of India’s most eminent medical experts, told the Times of India newspaper that she has “not seen anything like this before.”
”There is absolutely no efficacy data that has been presented or published,” she added.