According to the Brazilian authorities, the vaccine manufacturing plant did not meet good practice requirements
Brazil’s health regulator Anvisa has denied permission to import Bharat Biotech’s COVID-19 vaccine Covaxin into the country after its authorities claimed that the plant in which the vaccine is being made did not meet the Good Manufacturing Practice (GMP) requirements.
“…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 stated.
Earlier, on the back of the Indian government approving the indigenously developed Covaxin, the Brazilian Association of Vaccine Clinics (ABCVAC) had planned to buy five million doses of the vaccine. “We had been looking for solutions for the private market, and the possibility came up of using this Indian vaccine, which is very promising,” ABCVAC president Geraldo Barbosa had told TV network Globo News, reported the agency.
“It is an additional sale that will not interfere with the number of vaccine doses the government has ordered.” Covaxin is being developed by Bharat Biotech jointly with the Indian Council of Medical Research (ICMR)- National Institute of Virology (NIV).
Bharat Biotech had earlier said it also signed an agreement with Brazil-based Precisa Medicamentos for the supplies of Covaxin for the private markets in South America and submitted for EUA’s (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 Phase 3 clinical trials.