The Oswaldo Cruz Foundation (Fiocruz) of Rio de Janeiro today requested (8) the National Health Surveillance Agency (Anvisa) authorization for emergency use of 2 million ready doses of the vaccine against covid-19 from the Oxford / AstraZeneca consortium that will be imported from India. In the morning, the Butantan Institute, in São Paulo, had already made an emergency request for the use of the CoronaVac vaccine.
Emergency use allows vaccination to start in risk groups such as the elderly, indigenous people and health professionals. In the same way as established for CoronaVac, Anvisa estimates that the analysis should take place within 10 calendar days. Fiocruz explained that the request for definitive registration of the immunizer, which allows mass vaccination, should be made until January 15th.
The order made by Fiocruz, which conducts studies on the vaccine developed by AstraZeneca, specifically targets the use of 2 million doses produced in the Serum laboratory, based in India and one of the authorized manufacturers of the Anglo-Swedish pharmaceutical in that country.
Anvisa’s procedures
In a note, Anvisa informed that it has already started sorting the documentation present in the request of the laboratory and in the proposal for emergency use. The agency also explained that the first 24 hours are used to screen the process and check if the necessary documents are available.
If any documents or information are missing, Anvisa may request additional clarifications from the laboratory and the counting of the 10-day period will be interrupted. In the analysis, the information already analyzed by the agency will be used through the Continuous Submission process, specific for covid-19 vaccines.
