Brazil has given permission to the proposal to import Covaxin Vaccine Covid-19 Bharat Biotech to South America with several conditions.
The Brazilian National Health Supervisory Agency – Anvisa – previously refused permission to import Covaxin after the authorities found that Indian factories where Jab was made did not meet good manufacturing (GMP) practice requirements.
Brazilian health regulators also approved other proposals to import the Russian V Sputnik Vaccine to the country.
According to Anvisa’s agreement, Brazil is expected to receive four million doses of Covaxin at first.
After using the official dose, the agency will analyze data to monitor the use of vaccines to assess the next imported number.
“Anvisa ratified Friday the extraordinary imports of the Covaxin vaccine by the Ministry of Health for distribution and used in controlled conditions. Authorization defines a number of 4 million doses, which can only be used in certain conditions. The decision was taken at an extraordinary public meeting 9 From the Collegiate Board, “he said in a statement in Portuguese.
All batches that will be destined for Brazil must have been produced after the GMP adaptation carried out by manufacturer Bharat Biotech, according to corrective and preventive measures (corrective actions and capa) presented in Anvisa, the word regulator tells the condition to import covaxin.
On February 26, Bharat Biotech Ltd said it signed an agreement with the Brazilian government for a supply of 20 million doses of Covaxin during the second and third quarter of 2021.
Bharatbiotech presents an adequate action plan and fulfills all the pending problems related to GMP request certification, Anvisa said.
Bharat Biotech, on May 25, submitted a new request with Anvisa on the issue of OFGMP. Anvisa recently ratified Covaxininbrazil’s clinical trial behavior.
Approval for tests on immunisers developed in India will serve to assess the efficacy, safety and consistency between batch vaccines.