As reported by The Wire, National Health Surveillance Agency i.e. Agencia Nacional de Vigilancia Sanitaria (ANVISA) has decided to discard Bharat Biotech-manufactured Covaxin’s application for emergency use authorization (EUA).
On Friday, the Indian pharmaceutical company had informed Brazil’s regulator that Precisa Medicamentos was no longer authorized to represent it in the country. It had also claimed that it would continue to work with ANVISA to obtain the required approvals for Covaxin’s use in Brazil.
According to The Wire, the exaggerated claim became transparent after health regulator’s announcement on 23rd July i.e. Friday about the reassessment of applications for two processes namely EUA approval and clinical trails in the Latin American nation.
The unanimous decision was announced after Hyderabad-based Bharat Biotech terminated its Memorandum of Understanding (MoU) with Precisa Medicamentos of Brazil. It has now set the stage for cancellation of contract worth $300 million for the supply of 20 million Covaxin doses from India to Brazil.
On July 24, Meiruze Freitas, who is the rapporteur of the process stated that due to the interruption of the commercial relationship between companies as well as moving forward with a technical evaluation of a petition would indicate a significant waste of the efforts and resources invested by the administration.
Presently, Bharat Biotech has no representative in Brazil along with its request for EUA getting scrapped and suspension of Phase 3 trails of the vaccine.
