Brazil’s health regulator has refused permission to import Bharat Biotech’s coronavirus vaccine Covaxin after its officials found that the plant where the shots were being made did not meet its manufacturing standards, PTI reported on Wednesday.
Anvisa, Brazil’s National Health Surveillance Agency, said it had received the government’s request to import 20 million (2 crore) doses of Covaxin. The decision on this request was suspended because of “non-compliance with the requirements of Good Manufacturing Practices for Medicines”, the news agency reported, citing a gazette notification from the Brazil government on March 29.
Bharat Biotech, in response to the development, told NDTV: “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.’’
On March 8, Bharat Biotech had applied for emergency use-authorisation of its vaccine in Brazil, Reuters reported.
Also read: Covaxin showed 81% efficacy in third phase trials, says Bharat Biotech
Brazil is the world’s second-worst coronavirus-affected country. It has registered more than 1.26 crore coronavirus cases and 3,17,646 deaths, according to the Johns Hopkins University. The country had expected to receive 46 million (4.6 crore) vaccine doses in March, but it received just 22 million (2.2 crore), according to Reuters.
Covaxin has been developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research and the National Institute of Virology in Pune. It is one of the two vaccines being used in India’s inoculation drive.
The indigenous vaccine had shown 81% efficacy in phase-three trials in India, which involved 25,800 subjects.
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