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Bharat Biotech’s Covid-19 vaccine, Covaxin, received a setback as Brazilian health regulator has denied approval for its import.
The permission has been denied on the grounds that the vaccine manufacturing facility of the Hyderabad-based company did not meet the requirements of the Current Good Manufacturing Practice (CGMP) norms.
Bharat Biotech had last month entered into an agreement with Brazilian authorities to supply 20 million doses of Covaxin.
According to the information provided on the portal of the Brazilian health regulator, Anvisa, the reasons cited for the refusal of permission include non-compliance with the requirements of good manufacturing practices for medicines and (or) the non-compliance with the petition procedures submitted for analysis.
When contacted, the company said: “The requirements pointed out during inspection will be fulfilled, the timelines for fulfilment is under discussion with the Brazil NRA and will be resolved soon.’’ The 20 million dose order from the Brazilian Govt was still active, it added.
It is the first time that permission was denied to Covaxin by any foreign regulator which has demonstrated an interim efficacy of 81 per cent in phase-III clinical trials.
The company has so far applied for Emergency Use Authorisation (EUA) for Covaxin in about 40 countries.
Covaxin is currently being administered in India as part of the government vaccination as well as by private players in India, along with Serum Institute’s Covishield.
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