After several months of waiting, the National Health Surveillance Agency of Brazil (Anvisa) I decided unanimously reject the request of the Chinese laboratory Sinovac to apply the doses of its candidate, Coronavac, in minors. He did leave the door open for future approval requests, though.
According to the highest sanitary regulator of the South American giant, the Chinese pharmacist requested almost four months ago the respective approval of Anvisa of its inoculant serum in pediatric version, an antiviral compound that is already applied in China in children between the ages of three and 17, given the high levels of safety and efficacy shown by the drug in clinical trials.
However, the health authorities of Brazil decided to reject the approval of this pediatric formula in view of the lack of corresponding data from the experimental trials. In a statement, the agency explains that the scientific studies in phase one and two were carried out in a very small population of infants, which does not allow to specify for sure how effective and safe the antigen is.
So they invited the Chinese pharmaceutical company Sinovac to include new complementary data that can precisely support the lack of data from the first scientific trials. Along the same lines, Anvisa pointed out that the country’s health authorities are interested in the Coronavac pediatric formula, which is why a channel will be left open for a new re-evaluation of the compound.
Vaccination campaign in Brazil
Despite being the third country most affected by the pandemic, Brazil has managed to stay among the world’s top ranks as a leader in vaccinations with more than 174 million doses applied to date. Just over 53.2 million Brazilians have already completed the immunization scheme, which translates into 25% of the population, while 60% of the country’s inhabitants have received at least one dose.