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

 

 
Experts have raised concerns over India's emergency approval of a locally-produced coronavirus vaccine before the completion of trials. On Sunday, Delhi approved the vaccine - known as Covaxin - as well as the global AstraZeneca Oxford jab, which is also being manufactured in India.
Prime Minister Narendra Modi touted the approval as a "game changer".
The head of Bharat Biotech, which makes Covaxin, defended the approval process, 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 provides 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".
The All India Drug Action Network, however, 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 is absolutely no efficacy data that has been presented or published".
Even social media users were quick 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. But Krishna Ella, chairman of Bharat Biotech, met reporters on Monday and said the approval of Covaxin had not been rushed. He cited previous examples where emergency authorisation approvals had been given based only on immunogenicity data.
"Under Indian laws we can get emergency approval for the vaccine based on fulfilling five parameters after Phase 2 trails. That is what has happened with our vaccine. So it is not a premature approval," he said.
"We will complete the Phase 3 trials soon and provide the efficacy data for the vaccine by February."
The company currently has 20 million doses available and plans to produce about 700 million doses this year, Dr Ella said.
"We have four facilities coming up and we are planning [to make] around 200 million doses in Hyderabad, 500 million doses in other cities."