In a note, the regulatory agency listed a series of pending issues to authorize phase III clinical trials in Brazil; in all, 18 points need to be reviewed by the Chemical Union
The National Health Surveillance Agency (Anvisa) released a note on Tuesday, 2, considering as “good news” the disclosure of studies on the Russian Sputnik V vaccine in the scientific magazine Lancet, which show 91.6% of the immunization’s effectiveness against the new coronavirus. Despite the optimism, the regulatory agency recalled that it is necessary that “complete data generated in non-clinical and clinical studies in phases I, II and III” be submitted by União Química, the Brazilian manufacturer of vaccines, so that the efficacy and safety are attested. “The World Health Organization stresses that countries that are introducing vaccines to use must ensure that ‘vaccines meet strict international standards for safety, efficacy and quality, and to accelerate readiness for implantation,'” says an excerpt from the statement.
A list of all pending issues that need to be met by União Química for phase III studies to be authorized in Brazil was also listed by the agency. In all, 18 points need to be met so that the last phase of the studies, necessary for the request for emergency use to be accepted, can be carried out. Among them are the sending of quality data, clarifications on the non-inclusion of elderly participants over 65 years with comorbidities in the studies, explaining the inclusion of HIV-positive participants in the tests and adjusting a series of methodologies. The Chemical Union even submitted an application for emergency use of the vaccine in Brazil before completing phase III testing, but had its request denied by the regulator.