The National Health Surveillance Agency (Anvisa) and the Butantan Institute met, on Friday (9), to discuss the development of a possible trivalent vaccine against Covid-19.
According to the agency, the idea is that the vaccine is more effective not only against the original variant of the Coronavirus, but also against Delta and Omicron (BA.1).
During the meeting, the bodies analyzed information about an updated version of Coronavac, manufactured by Chinese biopharmaceutical Sinovac.
According to Butantan, so far, data on this production are still preliminary, as Sinovac has conducted only two pre-clinical studies.
The tests were only carried out on animals, but Sinovac is already recruiting volunteers to proceed with the human testing phase.
Also at the meeting, Anvisa’s technical team took the opportunity to signal which points should be observed in a future authorization request for the trivalent vaccine against Covid-19.
Criteria for proving the safety and efficacy of the new vaccine were also discussed. So far, however, there is still no request for authorization or clinical study of new versions of Coronavac in Brazil.
The Butantan Institute was responsible for formalizing, with Anvisa, the data that are currently available on the new vaccine and also the planning proposed by Sinovac regarding the next phases of clinical studies. The regulatory agency must then review the proposals.
Coronavac was the first vaccine against Covid-19 to be applied in national territory, under an initiative by the Butantan Institute in partnership with Sinovac.
In January 2021, the monovalent version, which protects against the original variant of the Coronavirus, was authorized on a temporary and emergency basis in Brazil. Currently, application is allowed from 3 years old.
Recently, Anvisa approved the use of bivalent vaccines from the manufacturer Pfizer, which demonstrate greater efficacy against Ômicron (original and strain BA.1).
The first batch of immunizer arrived in Brazil on Friday (9) with 1.4 million doses.
The shipment delivered this Friday will still be analyzed and evaluated by the National Institute for Quality Control in Health (INCQS).
According to the Ministry of Health, guidelines on the distribution, application and target audience of these doses will be informed through a technical note to be issued in the coming days.
Source: CNN Brasil
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