National watchdog says vaccines used in Brazil are safe

Brazil’s national sanitary regulator Anvisa announced that the public data on the use of vaccines against COVID-19 in the country has thus far shown no link between the inoculation and adverse effects or deaths. No change in the risk–benefit ratio has been reported, Anvisa stated.

In a note, the watchdog explains that the ratio assessment takes into account a large amount of data and notifications from users make up just a portion of the source. Other information includes safety report by producers, safety signals generated by the mathematical model devised by the World Health Organization (WHO), the exchange of data with other regulators and group discussions among specialists.

“Up to now, no known death has been reported where there are ties established with the use of the vaccines against COVID-19 authorized in the country. The vaccines in use in Brazil are considered safe,” the agency declared. “It is expected that people pass away due to other health problems, and even natural causes, when one takes into account the mortality rate known for each age group within the Brazilian population,” he added.

Notifications on vaccines and medications are submitted to Anvisa especially by health professionals, in addition to manufacturers themselves, who must report suspicious events or events that may prove relevant. These data are used by Anvisa as subsidies for its monitoring efforts.

“Since these are data notified by third parties, they are considered as being of lower scientific evidence and serve only as signs for Anvisa’s monitoring work. The complete assessment includes the processes mentioned before,” he explained.

Authorized for emergency use in Brazil today are the vaccine Covishield, developed by Oxford University in partnership with British pharmaceutical AstraZeneca and produced in Brazil by the country’s Oswaldo Cruz Foundation (Fiocruz); and vaccine CoronaVac, produced by Butantan Institute in collaboration with Chinese pharmaceutical firm Sinovac. They are being purchased and distributed to the states by the Health Ministry under Brazil’s national vaccination program.

Anvisa also granted registration for vaccine Cominarty, developed by US pharmaceutical firm Pfizer alongside Germany’s BioNtech. In this case, registration is definitive and for wide use. However, the inoculation is yet to be made available in the country.