Emergency use – Brazil’s Health Regulator suspends Sputnik V analysis deadline

RIO DE JANEIRO, BRAZIL – The Brazilian Health Regulatory Agency (Anvisa) released a note this Saturday (March 27), advising the suspension of the deadlines for analysis of the request for emergency use of the Russian vaccine Sputnik V, made last week by União Química, the company responsible for the Russian immunization product, in Brazil.

“Due to the absence of documents considered important for the analysis, as provided by law, the deadlines were suspended until the company presents the information described as ‘not presented’ in the disclosed panel,” says the agency.

According to Anvisa, the panel presents the percentage regarding the submission status of each of the reports and information necessary for the analysis of temporary and emergency use authorization.

Despite the deadline’s suspension, the Agency said it is continuing the analysis of the other information submitted by União Química.

Versamune

About Versamune, a vaccine developed in partnership with the University of São Paulo (USP), the company Farmacore and PDS Biotechnology, from the United States, Anvisa said it issued demands for more information to the USP Medical School of Ribeirão Preto, after analyzing the request to conduct clinical studies of phases 1 and 2 of the immunization development.

According to the Agency, the documentation was filed on Thursday (March 25) and that “the requirements do not suspend the analysis of the other information presented by the vaccine developers”.

Source: Agência Brasil