MercoPress. South Atlantic News Agency

Pfizer seeks clearance for Comirnaty to be used in Brazil on kids aged 5 to 11

Pfizer's vaccine has already been cleared for use on Brazilian patients between the ages of 12 and 15 on June 11

The pharmaceutical company Pfizer Friday filed an application before Brazil's National Health Surveillance Agency (Anvisa) for its COVID-19 vaccine named Comirnaty to be cleared for use on patients aged 5 to 11 years old.

Pfizer's request states that the dosage of the vaccine “will be adjusted and lower than that used for those over 12 years of age” and will be distributed in different packages, Anvisa said.

The laboratory noted that, according to preliminary data, “two doses of 10 micrograms of the vaccine was shown to be safe and capable of generating a high level of antibodies” in this age group.

Anvisa now has 30 days to study the request. Comirnaty is already being applied to children aged 5 to 11 in the United States since November 2, after the approval of health regulators, while European authorities are evaluating both Pfizer's and Moderna's drugs for this age group. The Brazilian agency needs to focus on “data on safety and adverse events” and dose adjustment, among other items, it was explained.

Pfizer's vaccine has already been cleared for use on Brazilian patients between the ages of 12 and 15 on June 11, and it is available in the country since February 23 for people over 16 years of age.

With 213 million inhabitants, Brazil has recorded over 610,000 COVID-19 deaths, a number surpassed only by the United States. At least 58.1% of Brazil's population has a full vaccination treatment.

Anvisa's directors and officials have received death threats by email due to the possibility that the entity authorizes anticovid vaccines for children from 5 to 11 years and a police enquiry has been launched into the matter.