Brazilian regulator says Covaxin fails to meet GMP standards

The Brazilian health regulator Anvisa has denied permission to import Bharat Biotech's COVID-19 vaccine Covaxin into the country after its authorities found that the plant in which the vaccine is being made did not meet the Good Manufacturing Practice requirements.

Reacting to it, the 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.

National Health Surveillance Agency Anvisa in its website said it received a request from the Brazilian health ministry to import 20 million doses of Covaxin.

However a decision on that was suspended by the regulator due to the absence of some key documents.

"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 March29.

Bharat Biotech in an email reply did not comment on the GMP issues.

Bharat Biotech International Limited on February 26 said it has signed an agreement with the Brazilian government for supply of 20 million doses of Covaxin during the second and third quarters of the current year.

The company had earlier said it also signed an agreement with Brazil-based Precisa Medicamentos for the supplies of Covaxin for the private markets in the South American country.

"The requirements pointed out during inspection will be fulfilled, the timelines for fulfillment is under discussion with the Brazil NRA and will be resolved soon," the company said in an email reply.

The agreement with Precisa Medicamentos is based on a long term partnership and will continue, Bharat Biotech said.

To another query, the vaccine maker said it has submitted for emergency use authorisation in more than 40 countries and several countries have already issued the authorisation and supplies are in process.

Covaxin has demonstrated an interim vaccine efficacy of 81 per cent in the Phase 3 clinical trials.

The trials involved 25,800 subjects, the largest ever conducted in India, in partnership with the Indian Council of Medical Research, the city-based-based company had earlier said in a statement.