New Delhi: Brazil’s health regulator Anvisa – short for the Portuguese Agência Nacional de Vigilância Sanitári -- has denied permission to import Bharat Biotech's vaccine Covaxin after authorities concluded that the plant in which the jab is made did not meet good manufacturing practices (GMP).
Reacting to it, the Hyderabad-based vaccine maker said it is working towards resolving the issues cited during the inspection and the order of 20 million doses from the Brazilian government is still active.
The regulator apparently had a rethink due to the absence of some key documents and lack of what it describes as GMP issues. Bharat Biotech in an email reply did not comment on the hiccups.
It said instead it has also applied for clearance in Thailand and the Philippines. In all, around 40 countries have expressed interest in Covaxin, the company claims. These include Iran, Nepal, Mauritius, Paraguay and Zimbabwe.
Covaxin has demonstrated an interim vaccine efficacy of 81 per cent in the Phase 3 clinical trials. Bharat Biotech further claims the vaccine is also effective against the UK variant of the virus, a good reason for not changing the composition of Covaxin to enhance its efficacy against the mutants.
Website Universo Online has reported that the Brazilian concerns related to non-adherence to demands for documentation, methods of analysis, and integrity of containers. Methods used for “sterilising, disinfecting, removing or inactivating viruses” also came under the scanner, UOL reported.
Anvisa has certified four vaccine makers, including three units belonging to the Johnson & Johnson group, and one which is part of Brazilian drugmaker União Química, which has an agreement to produce Russia’s Sputnik V shot locally.
Under the 'Vaccine Maitri' initiative, India has been providing coronavirus vaccines to more than 70 nations, including Maldives, Bhutan, Bangladesh, Nepal, Sri Lanka, Myanmar, Mauritius, Seychelles and the Gulf nations.
