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BENGALURU: Criticism of India’s approval of a local COVID-19 vaccine without evidence of its efficacy increased on Wednesday (Jan 6) after news that a regulatory panel approved the injection just one day after asking the manufacturer of the vaccine plus proof that it would work.
Recommendations from the subject matter expert committee (SEC) of India’s drug regulator released on Tuesday show that the panel asked Bharat Biotech International to submit more efficacy data for its COVID-19 injection before it could consider the approval of treatment.
“After detailed deliberation, the committee recommended that the company … may conduct an interim efficacy analysis for further consideration of the emergency restricted-use approval,” the SEC’s recommendations show at a January 1 meeting. .
The next day, the committee recommended approving the Bharat Biotech vaccine for “restricted use in emergency situations of public interest as an abundant precaution.”
READ: India’s approval of homegrown COVID-19 vaccine criticized for lack of data
The SEC also separately recommended emergency use authorization for the Oxford University / AstraZeneca COVID-19 vaccine, which is being produced by the Serum Institute of India.
Bharat Biotech’s approval of COVAXIN had already faced criticism from opposition lawmakers and health experts for a lack of efficacy data, usually obtained from a large Phase III human trial, which the manufacturer is still conducting.
News of the SEC recommendations drew further criticism.
“Was the approval of the Committee of Experts on Matters (SEC) a commanding action? This is as serious as it can be,” said Manish Tewari, an opposition lawmaker, on Twitter.
Health experts questioned why the SEC abruptly recommended approval a day after asking Bharat Biotech for more analysis.
READ: India’s Bharat Biotech aims to produce 700 million doses of COVID-19 vaccine in 2021
“The SEC … appears to have been pressured overnight to reconsider its decision and give its approval the next day, albeit covered by many conditions,” the All India People’s Science Network, a network of organizations, said in a statement. science advocacy groups.
“We are perplexed by the abrupt change in the SEC’s thinking from the first two meetings to the third day that approval was recommended, while seemingly dismissing the need for efficacy data as a condition for approval,” the Network said. All India Action Against Drugs, said a non-profit health watchdog.
Both Bharat Biotech and government officials have outlined regulatory provisions that allow for rapid approval of drugs for serious diseases even without Phase III trial data.
Neither India’s drug regulator nor Bharat Biotech responded to Reuters requests for comment on Wednesday.
Regulators also granted approval to Bharat Biotech’s vaccine only “in clinical trial mode,” unusually cryptic language that left some experts baffled.
“They have introduced terminologies that are confusing,” said Giridhar Babu, professor of epidemiology at the Public Health Foundation of India. “The phrase ‘in clinical trial mode’ is not generally a term that you will see in approvals.”
Any confusion around vaccines could damage immunization programs by generating mistrust, Babu said. “It takes decades of work to build confidence in vaccines.”
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