Brazil health regulator's technical staff recommend against Sputnik V vaccine
- The recommendations by Anvisa's technical staff will be taken into account by the regulator's board, which will announce its decision later on Monday.
The Brazilian health regulator's technical staff on Monday recommended against approving imports of the Russian-made Sputnik V Covid-19 vaccine requested by governors battling against a deadly second wave of the virus.
The recommendations by Anvisa's technical staff will be taken into account by the regulator's board, which will announce its decision later on Monday. Anvisa had previously said there were "critical issues" surrounding the vaccine's effectiveness and safety that needed clarifying.
Ana Carolina Moreira Marino Araujo, general manager for health monitoring, said that taking into account all the documentation presented, data acquired at in-person inspections and information from other regulators, Anvisa's technical staff said "inherent risks" were too great at this time.
A crucial issue was the presence in the vaccine of the adenovirus that could reproduce, a "serious" defect, according to Anvisa's medicines and biological products manager Gustavo Mendes.
Brazil's vaccination program has been blighted by a series of delays and procurement failures, turning the country into one of the world's deadliest Covid-19 hotspots this year and pushing the national health system to the brink of collapse.
Brazil has registered 14.4 million confirmed cases of the virus and almost 400,000 deaths since the onset of the pandemic over a year ago, much of that in the last few months.