ENVISA – The National Health Monitoring Agency published, this Tuesday, the result of a certificate of good manufacturing practices of three laboratories that requested registration of vaccines against Kovid-19. One of them was rejected by Bharat Biotech, and the other two were approved by Unio Quica and Janssen-Silag.
The agency inspected the facilities of Bharat Biotech, which manufactures covaxine vaccine, in early March. And he concluded that the action plan sent by the company was not enough to mitigate the risks involved in the manufacture of the vaccine in the short term.
The company Precis Comercialização de Medicamentos, a representative of Bharat Biotech in Brazil, proposed to optimize all problems by 30 July. But Envisa considered that the proposed measures would have no effect on the efficacy and safety of the product, and that batches of vaccines manufactured prior to the change would not guarantee immunity protection.
Prison Medimentos and Bharat Biotech have informed that they will appeal against Anvisa’s decision, presenting all revised adjustment conditions and evidence of all appropriate procedures already done to obtain the certificate.
For kovaxin, the Ministry of Health contracted to purchase 20 million doses.
União Química, which will produce the Russian Sputnik V vaccine in Brazil, had its factory in Guarulos, São Paulo, inspected between March 8 and 12. The factory is certified to manufacture, sterilize, and fill vaccines.
Production of the laboratory’s pharmaceutical inputs, which will be carried out at the Brasilia factory, will also have its inspection scheduled after completing the technology transfer of the laboratory and facilities for producing the input.
The Ministry of Health purchased 10 million doses of Sputnik V, but these will be imported from Russia by the Unio Qumica laboratory.
The factories used by Johnson & Johnson Group company Janssen, two in the United States and one in South Africa, also had their certification approved by ANVISA, which completed production validation of this laboratory. The Ministry of Health has contracted 38 million doses of Janssen’s vaccine against Kovid.