Sunday, May 29, 2022

Brazilian govt’s 20 million dose order is still active: Bharat Biotech

By Telangana Today

Published: Published Date - 09:23 PM, Wed - 31 March 21

Representational Image. "The agreement with Precisa Medicamentos is based on a long term partnership and will continue,” Bharat Biotech stated.

Hyderabad: Following the denial of certificate for good manufacturing practices (GMP) by the Brazilian Health Regulatory Agency (Anvisa) to Bharat Biotech’s Covaxin (Covid-19 vaccine), the Hyderabad-based vaccine maker said, the requirements pointed out during inspection will be fulfilled, the timelines for fulfilment is under discussion with the Brazil National Regulatory Authority and will be resolved soon.

“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,” the company stated.

“Considering the non-compliance with the requirements of Good Manufacturing Practices for Medicines, or the non-compliance with the petition procedures submitted for analysis, advocated by current legislation, resolves: Refuse the Request (s) for Certification of Good Manufacturing Practices for Medicines of the company (ies) contained in the ANNEX,” a Brazilian government gazette said on March 29.

Bharat Biotech signed an agreement with Brazil’s Health Ministry in the last week of February for supply of 20 million doses of Covaxin. The value of the deal is estimated at around Rs 2,140 crore ($1.6 billion Brazilian real). The delivery of Covaxin was scheduled during the second and third quarters of 2021.

The vaccine maker had applied for emergency use of Covaxin in Brazil on March 8. Anvisa’s approval is a necessary step for Brazil’s process of allowing the vaccine for emergency use. Covaxin is one of the two vaccines currently being administered in India. Brazil is the second-worst Covid-19-affected nation globally, in terms of mortality, after the US.

In the first interim analysis of Covaxin released by Bharat Biotech early March, the company said, the vaccine candidate demonstrated an interim vaccine efficacy of 81 per cent in its Phase 3 clinical trial. The trials involved 25,800 subjects, the largest ever conducted in India, in partnership with the Indian Council of Medical Research.