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Brazil greenlights new clinical trials of COVID-19 vaccine

Brazil’s national sanitary regulator Anvisa today (Apr. 19) reported it approved new clinical trials of a vaccine against COVID-19 last Friday (16).

The candidate vaccine will have two doses with a 22-day interval between them. Clinical development is sponsored by China-based Sichuan Clover Biopharmaceuticals.

The clinical trial approved is placebo-controlled, in order to evaluate the inoculation’s efficiency, immunogenicity, and safety on patients aged 18 and older.

Likely to participate in this stage are 22 thousand volunteers from Latin America, South Africa, Belgium, China, Spain, Poland, and the UK. In Brazil, volunteers should total 12.1 thousand across the states of Rio Grande do Sul, Rio Grande do Norte, and Rio de Janeiro.

Assessment

To allow clinical trials to begin, Anvisa reported it held meetings with its pharmaceutical team in order to assess all technical requirements necessary for the testing.

Since Brazil declared state of public calamity due to the pandemic of the novel coronavirus, the watchdog has adopted strategies to speed up analyses and decisions on measures to tackle COVID-19.

“One such strategy was the creation of a committee to assess clinical trials, registration, and post-registration changes in drugs for the prevention against, or treatment of the disease. The group also works in efforts to reduce the risk of shortages in medications with an impact on public health care due to the pandemic,” it added.

Authorization

To grant its approval, Anvisa analyzed the data of the product’s previous development stages, including tests in vitro and in animals, as well as preliminary data from ongoing clinical trials. The result obtained so far indicate an acceptable safety profile of candidate vaccines.

This is the sixth study on a vaccine against the new coronavirus authorized by Anvisa. The last authorizations were granted on June 2, 2020, for clinical tests on the vaccine developed by Oxford University and company AstraZeneca; on July 2, for the vaccine of Sinovac Research & Development, in partnership with Butantan Institute; on July 21, for the Pfizer/Wyeth vaccine; on August 18 for vaccine Janssen-Cilag; and on April 8, for the vaccine of Medicago R&D.

Reference