Sunday, April 18, 2021

Anvisa authorizes new clinical trial of vaccine against Covid-19 in Brazil – Prime Time Zone

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Candidate immunizer uses particle similar to coronavirus; 3,500 volunteers are expected to participate in the country

Anvisa / AscomIt is the fifth vaccine to have clinical studies in Brazil approved by Anvisa

The National Health Surveillance Agency (Anvisa) authorized this Thursday, 8, a new clinical trial of vaccine against Covid-19 in Brazil. The development of the immunizer is being sponsored by the biopharmaceutical company Medicago R&D Inc, based in Canada, and by the British pharmaceutical company GlaxoSmithKline (GSK). Previously, Anvisa had already authorized testing in Brazil of the vaccine for Oxford/Astrazeneca, gives CoronaVac, the immunizer of Pfizer and yes Janssen. The clinical trial consists of three stages and Brazil will participate in stage 3, which corresponds to stages 2 and 3 of the study, explains Anvisa. This is because the phases are being grouped to speed up the process.

At this stage, the safety and efficacy and immunogenicity of the vaccine will be evaluated in adults aged 18 years or older, chosen at random. The study will be placebo-controlled and observer-blind. In phase 3, it is planned to include up to 30 thousand volunteers distributed between Canada, the United States, in addition to Latin America, the United Kingdom and Europe. In Brazil, the participation of 3,500 volunteers in phase 2/3. Phases 1 and 2 are already underway in Canada and the United States. The candidate vaccine uses a particle similar to coronavirus. It is composed of the protein Spike (S) in the form of virus-like particles, co-administered with an adjuvant, in two doses with interval 21 days between doses. To grant authorization, Anvisa analyzed data from previous stages of development, including non-clinical studies in vitro and in animals, as well as preliminary data from ongoing clinical studies.

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