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The president-director of Anvisa (National Health Surveillance Agency), Antônio Barra Torres, said this Monday (December 7, 2020) in an interview with the Panico da Jovem Pan program that “none of the 4 vaccines under development in Brazil presented registration protocols”. He said that none of the COVID-19 immunizers have the backing for widespread use to date.
Barra Torres affirmed that none of the 4 vaccines was entered in the registration documents and that, for this reason, the agency does not have the protocols to be analyzed. “Before we can verify these registration protocols, we need to access the clinical trial documents for phase 3 of the trials. However, these studies have not yet been completed. To register the coronavirus vaccine, we need at least 60 days to analyze the documents“, said.
He also spoke of the need for a rigorous drug approval process because “we are talking about something very serious“. Barra Torres said that the agency is trying to certify a mother or father, for example, that they can use the immunizers with certainty of quality, safety and effectiveness.
São Paulo Governor João Doria (PSDB) said on Monday (7.12.2020) that vaccination against covid-19 in the state will begin on January 25, the anniversary of the capital of São Paulo.
The announcement was made by the toucan in an interview in the Palácio dos Bandeirantes, seat of the state government, to present the PEI (State Plan for Immunization). The vaccine offered will be CoronaVac, developed in partnership with the Butantan Institute with the Chinese pharmaceutical company Sinovac.
Regarding Doria’s announcement, Barra Torres stated that “it is not yet time to set deadlines”. He said that in the last week, Anvisa declared itself open to analyze requests for emergency use of the vaccine, but so far it has not received any official request from the laboratories. He also stated that interested parties can request emergency use at any time and that from that moment on, the agency will seek to carry out an analysis.well done and in the shortest time possible“.
“However, we do not set an approval month or day. To the authorities who do, I wish them luck. In the meantime, we will continue to work with the real world, the scientific world. If possible, the vaccination will be advanced. If not, it will also be for the good of society. The vaccines will arrive in the shortest and best time possible, but there is no way to set a day or a month.“Said the general director of the agency.
For Barra Torres, immunizers must be commercialized and included in the National Immunization Program in the first half of 2021 ”.Despite the prognosis, I am not going to generate expectations in the population that is already suffering so much from the pandemic with contradictory news (…) The process of approval and registration of immunizers is dynamic, that is, there may be interference and problems capable of changing the entire calendar . . We can have the grateful joy that, at the end of the year, we have a concrete possibility to distribute the vaccine or, even in 2020, we approve the emergency use. These assumptions can happen, but we should not set deadlines.“He concluded.
Only vaccines in the 3rd clinical phase (massive application) that are being tested in Brazil will be able to request an emergency use. So far, 4 candidates meet these conditions: the one developed by Oxford and AstraZeneca, the one from Pfizer and BioNTech, the CoronaVac (developed by Sinovac and the Butantan Institute) and the one from the Janssen group.
Phase 3 does not have documents yet, says Anvisa
To the newspaper The State of S. Paulo Anvisa sent a note to clarify the analysis of the Sinovac vaccine studies. The agency stated that, to date, 2 sets of safety and efficacy study data have been submitted through the continuous submission procedure. The 1st was sent on October 2, 2020 and its analysis has already been completed. The second was sent on 30.out.2020 and is in analysis.
In addition, Anvisa says that no data related to phase 3 was sent, which is the phase that confirms the safety and efficacy of the vaccine. “This data is essential for evaluating both emergency use authorization requests and registration requests.“, said.
The inspection at Sinovac was completed on Friday (December 4, 2020) and the document listing all the inspection findings (possible non-conformities) will be formally sent to the Butantan Institute within 3 business days after the inspection. Butantan must formally respond to the document within 5 business days of receipt.
Based on the answers given by Butantan, the inspection team prepares the Inspection Report, which, even with a maximum processing period of 31 business days, was scheduled for this mission in a maximum of 10 business days. This report is the conclusive document regarding certification and its conclusions may lead to approval or denial of certification.
“Adding the days presented, it is concluded that the Inspection Report must be completed between December 30 and January 11, 2020.Says Anvisa.
“It is important to note that for the request for authorization for emergency use, it is expected that the data described in the guide on the minimum requirements to submit a request for temporary authorization for emergency use, on an experimental basis, of covid-19 vaccines“, Ends a note.
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