Brazil Health Regulator Denies Permission to Import Covaxin

The Brazilian regulator pointed out a lack of “good manufacturing practices” after an inspection at Bharat Biotech. 

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Brazil's health regulator has denied permission to import Covaxin, India’s indigenous vaccine manufactured by Bharat Biotech for not maintaining “good manufacturing practices,” reported NDTV. Brazil, which was the worst-hit by COVID-19 after the United States, had ordered 20 million doses of the vaccine.

An inspection that was led by Agencia Nacional de Vigilancia Sanitari (ANVISA) from 1-5 March reportedly revealed issues concerning Hyderabad-headquartered vaccine maker’s manufacturing processes. According to reports, the Brazilian health regulator had said that Covaxin had been rejected "considering the non-compliance with the requirements of Good Manufacturing Practices for Medicines.''

As per ANVISA’s statement, different non-conformities were found at Bharat Biotech’s manufacturing site, implying a risk to manufacturing and product quality assurance. “This, in turn, implies a health risk for users of the vaccine in Brazil,” the health regulator said.

Bharat Biotech, in its response, told NDTV that 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.”

Covaxin, which is produced by Bharat Biotech in collaboration with the Indian Council for Medical Research, was approved for emergency use by the national drug regulator in January. The vaccine was expected to be used only in the clinical trial mode.

After the vaccine showed an interim efficacy of 81 percent in the phase 3 clinical trials in India, it was taken off clinical trial mode earlier this month.

Bharat Biotech said that the vaccine is effective against the UK variant of the virus. The government, in a statement, said that it had not yet felt the need to change the composition of Covaxin in view of its efficacy against the mutant variants.

Bharat Biotech also said that the 20 million dose order from the Brazilian government is still active. “The agreement with Precisa Medicamentos is based on a long term partnership and will continue,” Bharat Biotech was quoted as saying by The Indian Express.

India has been providing coronavirus vaccines to more than 70 nations including Bangladesh, Nepal, Sri Lanka, Myanmar, Maldives, Bhutan, Mauritius, Seychelles, and the Gulf nations under the ‘Vaccine Maitri’ initiative.

(With inputs from NDTV and The Indian Express)

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