Anvisa updates information on the analysis of vaccines against covid-19
The National Health Surveillance Agency (Anvisa) updated this Monday (29) the status of evaluation of vaccines against covid-19, including the indication for immunization of children, booster doses and requests for emergency use.
Kids
The Agency is considering the inclusion of Pfizer's vaccine indication for the immunization of children aged 5 to 11 years. The process is being analyzed by the technical team, which asked the pharmacist for additional data to assess the request.
“For this request, Anvisa is adopting a different strategy for the technical analysis of clinical studies for children, seeking the involvement of different entities”, highlighted the agency. "Invitations were sent to representatives of the Brazilian societies of Immunology, Infectology, Pediatrics and Epidemiology, requesting the collaboration of these entities in the process."
As soon as there is confirmation by the entities and representations, Anvisa informed that a meeting will be held with the presentation of available data for discussion and technical assistance in decision-making.
Reinforcement
Last Wednesday (24), the agency approved the inclusion of the booster dose in Pfizer's vaccine package insert. The guideline is to adopt the application of the homologous vaccine (the same vaccine) in the booster immunization.
There were also, according to Anvisa, requests to include a booster dose in Janssen's vaccine dosage, as homologous and heterologous booster (different vaccine) and also by AstraZeneca, as homologous booster. Both requests are under analysis by the technical area.
Vaccines under evaluation
Anvisa informed that it received, on the last 18th, the request for emergency use of the Convidecia vaccine, manufactured by the CanSino laboratory. The request was presented by the Biomm laboratory, the manufacturer's representative in Brazil. The vaccine is produced in China.
There is also an application for emergency use sent at the end of July of the Adsorbed vaccine (inactivated) manufactured by Sinopharm.
The two requests, according to the agency, had their analysis period suspended due to the need to supplement the data. “Once the information is completed, the requests are under analysis by the technical area”, informed the agency.
Text translated using artificial intelligence.
