Request was presented by Blau Farmacêutica, which represents the Chinese laboratory in Brazil; immunizing agent is applied in two doses, with an interval of three to four weeks between them
A National Health Surveillance Agency (Anvisa) received this Monday, 26, the request for emergency use of the vaccine against Covid-19 from Sinopharm. The request was presented by Blau Farmacêutica, which represents the vaccine from the Chinese laboratory in Brazil. As well as the immunizing agents of Pfizer–BioNTech, Johnson & Johnson, AstraZeneca–Oxford University, Modern and Sinovac, Sinopharm’s vaccine also went through the review of scientific data and evaluation of the efficacy and safety criteria required by the World Health Organization (WHO) and had its emergency use approved by the international entity. Just like the CoronaVac, the immunizing agent is produced from an inactivated virus. The vaccine is given in two doses, with an interval of three to four weeks between them. It is recommended for people over 18 years of age, according to data known to date.
Sinopharm’s researches were developed in countries such as Argentina, Peru, UAE, Egypt e China. Anvisa points out that the lack of tests in the country does not prevent the submission of an authorization request for emergency use or registration. The first 24 hours will be used to screen the process and verify that the documents needed for evaluation are available. If important information is missing, Anvisa may request additional information from the laboratory. The period for analyzing the request for emergency use by the agency varies from seven to 30 days. “By standard, the evaluation period will be seven days when there is clinical development of the vaccine in Brazil or when the report or technical opinion issued by the foreign health authority is able to prove that the vaccine meets the standards of quality, efficacy and safety established by the WHO or by the ICH (International Council for Harmonization of Technical Requirements for Medicines for Human Use) and by the PIC/S (Cooperation Scheme in Pharmaceutical Inspection)”, the agency details, which adds that the deadline for evaluation of the application for use emergency does not consider the process time in technical requirement status.