WHO's Covaxin Approval delay deliberate?
According to reports, the World health Organization (WHO) has again delayed the emergency use authorisation (EUA) for Covaxin, an Indian-developed Covid-19 vaccine, and has forwarded further technical questions to its Hyderabad-based producer Bharat Biotech. This is despite the fact that Bharat Biotech has said that it has provided all data necessary for Covaxin clearance. According to the news report, a source acquainted with the situation stated that this is a normal procedure that causes no worry. “It's the standard procedure. Experts pose questions, which the firm must respond to,” the aforementioned individual stated.
Bharat Biotech must respond to further technical questions from the WHO before receiving permission. Even while the health ministry suggested that an EUA from the WHO was on the way, this has happened.
The topic of the delay is anticipated to be discussed in a Strategic Advisory Group of Experts (SAGE) meeting on october 5th.
With international crossings reopening, people twice vaccinated with various COVID-19 shots – including Covaxin – are being classified as 'unvaccinated,' making travel abroad difficult, if not impossible, in some cases.
Since its inception, Covaxin – billed as India's first entirely indigenous vaccine - has been plagued by inadequate transparency and mismanagement.
Bharat Biotech's application for Covaxin clearance was also denied by the US Food and Drug Administration (FDA). According to reports, the business only provided partial data from clinical studies, omitting data from Phase 3 trials.
Bharat Biotech must respond to further technical questions from the WHO before receiving permission. Even while the health ministry suggested that an EUA from the WHO was on the way, this has happened.
The topic of the delay is anticipated to be discussed in a Strategic Advisory Group of Experts (SAGE) meeting on october 5th.
With international crossings reopening, people twice vaccinated with various COVID-19 shots – including Covaxin – are being classified as 'unvaccinated,' making travel abroad difficult, if not impossible, in some cases.
Since its inception, Covaxin – billed as India's first entirely indigenous vaccine - has been plagued by inadequate transparency and mismanagement.
Bharat Biotech's application for Covaxin clearance was also denied by the US Food and Drug Administration (FDA). According to reports, the business only provided partial data from clinical studies, omitting data from Phase 3 trials.