The Butantan Institute wants to request the definitive use of the Coronavac vaccine, from the Chinese laboratory SinoVac, at Anvisa (National Health Surveillance Agency) by December and repeat the request to immunize children and adolescents aged 3 to 17 years. The wait, for now, is for new documents from China.
These updates were taken to Brasília by the institute’s director, Dimas Covas, who spoke, on the afternoon of Wednesday (10), with the executive secretary of the Ministry of Health, Rodrigo Cruz. It was Cruz who spoke to the press.
“We talked about deadlines. We asked them what the expected approval period for the definitive registration of Coronavac at Anvisa was. And we also make it clear that, for this year, there is no expectation of buying, not only Coronavac, but any other immunizing agent”, explained Cruz.
“The expectation is that we will turn the year with 130 million doses to spare and we already have two purchase strategies to be able to make use of the vaccination process in 2022, guaranteeing one dose for all Brazilians over 18 years of age and two for the over 60. And if, eventually, we have an expansion of the vaccinated public, we will also have immunization agents”, explained Cruz.
Strategies
The strategies mentioned are the purchase of an additional 100 million doses of vaccine from Pfizer and an additional 120 million doses from AstraZeneca.
This last point, the expansion of the vaccinated public, is also of interest to Butantan because Dimas Covas told Cruz that the institute will repeat the request at Anvisa for the immunization of children and adolescents. In August, the regulatory agency disapproved the demand for understanding that documents were missing.
“Dimas Covas told me that they are waiting for more documents from China for this as well,” said Cruz.
Surprise
Technical sources at the agency told the CNN report that they were surprised by Dimas Covas’ speech about the definitive registration request until December, as the Butantan did not fulfill the agreement to send the immunogenicity data until October 31st.
The institute was notified of this and the agency referred the case to the Federal Attorney General. As all commitments go through the Federal Attorney General, this situation at the Attorney General’s Office is only administrative and legal. It will not extend the analysis period, which is 30 days.
These agreements are not mandatory. They are being done during the pandemic for all analysis processes to be faster.
On the vaccination of teenagers, these sources said that there is still weakness in the data, which were shown at the last meeting last week.
Reference: CNN Brasil
