Brasília – The Brazilian Health Regulatory Agency (Anvisa) received this Monday (26) a temporary authorization request for emergency use of a vaccine against COVID-19. This time, the request was made by the Chinese laboratory Sinopharm and presented by the company Blau Farmacêutica, which represents the immunizer in Brazil.
Sinopharm’s vaccine is made from an inactivated virus. The immunizing agent is given in two shots, with an interval of three to four weeks between them. The product is recommended for people over the age of 18, according to existing data.
“The development of the vaccine had no clinical trials in Brazil, which does not prevent the submission of an authorization request for emergency use or registration with Anvisa. The research was carried out in countries like Argentina, Peru, the United Arab Emirates, Egypt, and China,” explained Anvisa in a notice. In May, this immunizing agent was approved for emergency use by the World Health Organization (WHO). Pictured above, vaccines are being given in Dubai.
Assessment and deadlines
According to Anvisa’s protocol, the first 24 hours will be used to screen the process and check if the documents required for assessment are available. If important information is missing, the agency may request additional documentation from the laboratory. According to the resolution for the emergency use of vaccines, the assessment period can last seven or 30 days, depending on the specific case.
Translated by Elúsio Brasileiro
