The analysis and approval of Sputnik V by Anvisa is still missing. In a statement, the agency said it had proposed meeting with governors next week.
On Wednesday (31), the agency had confirmed that it had received part of the documents that were missing from the Sputnik V emergency use request process. The material is already being evaluated by the technicians, but Anvisa has already informed that there are still pending issues. Therefore, the 7 days to assess authorization for emergency use remains suspended until the submission of the pending documentation.
The vaccine is one of those negotiated by the Ministry of Health and is already included in the schedule with delivery scheduled for the current month. The federal government has purchased 10 million doses, and expects 400,000 by the end of April, 2 million in late May and 7.6 million in June.
On Tuesday (30), the pharmaceutical company União Química claimed to have completed the production of the first batch of the Sputnik V vaccine packaged in Brazil based on the technology transfer of the Active Pharmaceutical Ingredient (IFA) from Russia to the Brazilian company.
The data sent to Anvisa is part of the new application for authorization for emergency use of the vaccine in Brazil, filed on March 26. The documents sent by União Química meet one of the four requirements set forth in Item XIV of Guide No. 42/2020, which deals with manufacturing locations and documentation related to Good Manufacturing Practices (GMP) of manufacturing locations.
This information is part of the minimum requirements for submitting a request for temporary authorization for emergency use, on an experimental basis, of vaccines against Covid-19. The material sent is already being evaluated by the technical team to verify compliance with previously detected issues.
Anvisa informed, however, that three items related to “Good Manufacturing Practices” are not included in the documentation received.
The agency awaits, for example, a “Inspection report (from the factory) issued by a participating authority in the Pharmaceutical Inspection Co-operation Scheme (PIC / S)”. PIC / S is, in free translation, a Pharmaceutical Inspection Cooperation Scheme that brings together among its members the main health agencies in the world.
The agency also pointed out the lack of “process validation” of manufacturing and “risk management in relation to cross contamination resulting from the inclusion of the product in the line”.
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