The Brazilian laboratory Biomm presented to Anvisa (National Health Surveillance Agency) a request for the emergency use of the Convidecia vaccine, developed by the Chinese company CanSino against Covid-19.
The company has an agreement to import and produce in Brazil the vaccine applied in a single dose. The process arrived at the agency on Monday (8), but the technical area opened the analysis on Wednesday (10).
“The first 24 hours are dedicated to screening the process to verify that the necessary documents are available. If there is important information missing, the agency can request additional information from the laboratory,” said Anvisa, in a note.
After this screening period, which should end this Thursday (11), the agency has seven working days to issue an opinion on emergency use. The deadline is suspended when Anvisa asks for “technical requirement”, that is, some additional information from the laboratory.
The five directors of Anvisa decide in a collegiate meeting whether or not to release the emergency use of Covid-19 vaccines.
Convidecia, CanSino’s vaccine, uses an adenovirus to teach the human immune system to identify and fight Covid, something similar to that seen in Covishield, AstraZeneca/Oxford’s vaccine already in use in Brazil. The immunizing agent must be kept in a common refrigerator, at 2°C to 8°C, which usually facilitates logistics.
On February 24, CanSino announced that the vaccine is more than 65% effective against all symptomatic cases of the disease.
In May, the company Belcher, from Paraná, presented an application for emergency use of Cansino’s vaccine. But the process at Anvisa was closed after the Chinese laboratory broke the agreement with the then representative in Brazil, which was in Covid’s CPI target.
In June, the Ministry of Health reached an agreement to purchase the vaccine from CanSino, through Belcher. The idea was to acquire 60 million doses at US$ 17 per unit, but the purchase did not advance.
The Coronavac immunizers and the model developed by Janssen are guaranteed for emergency use in Brazil.
The vaccines developed by AstraZeneca, and manufactured in Brazil by Fiocruz, and by Pfizer, on the other hand, have definitive registration with the health agency.
To endorse emergency use, Anvisa assesses whether the benefits of the immunizing agent outweigh risks and uncertainties. This type of authorization is provisional and intended mainly for the application of doses in the SUS. Although the analysis is faster, the agency only releases the product it considers safe.
“The analysis of the request for emergency use is carried out by a multidisciplinary team that involves specialists from the areas of registration, monitoring and inspection. The team has been working in an integrated manner, with optimized actions and monitored by the commission that involves three directors of the agency”, said to Anvisa.
The agency assesses data on the efficacy, safety and quality of immunizers. It also considers the manufacturing processes. In some cases, Anvisa uses the analyzes already carried out by health agencies in other countries
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