RIO DE JANEIRO, BRAZIL – Brazil’s National Health Regulatory Agency (ANVISA) announced this Monday, May 31, that it is analyzing a request to authorize the Pfizer/BioNTech coronavirus vaccine for children age 12 and older.
According to the agency, Pfizer’s request to include this age group in the vaccine package insert was submitted on May 13 and ANVISA’s deadline for evaluation is up to 30 days. Currently, the vaccine is permanently authorized in Brazil for people aged 16 and older. The country has received 3.4 million vaccine doses so far, out of a contracted total of 200 million.
The vaccine has been authorized for use in adolescents 12 and older in other countries, such as the United States and the European Union.
Pfizer’s vaccine was the first to be tested and approved for children. Trials were conducted with 2,300 adolescents aged 12 to 15, with half receiving the same two doses administered to adults and the other half a placebo, i.e., unvaccinated. There were 16 Covid-19 cases, all in the group that was not administered the vaccine.
Pfizer is also starting to test the vaccine in even younger children, aged 5 to 11.
Change in storage temperature rules
On Friday, May 28, ANVISA changed the storage and conservation rules for Pfizer’s vaccine. The vaccine can now be kept at a temperature of between 2ºC and 8ºC for up to 31 days. The new regulation allows the vaccine to be applied outside Brazil’s capital cities, the only ones with very low temperature storage facilities.