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, news agency PTI reported. "...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 quantity 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 responded to NDTV: ''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.''
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 the 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 the Phase 3 clinical trials.
-Inputs from PTI
