Pfizer Vaccine: The Food and Drug Administration (FDA), the United States’ drug regulatory agency, on Monday (10) authorized the use of the Covid-19 vaccine by the Pfizer-BioNTech conglomerate in adolescents aged 12 to 15 years. The decision, supported by a clinical study of 2,260 individuals in this age group, is considered a decisive step in the process of returning to normality in the country.
However, the agency’s authorization does not mean the automatic start of immunization in this adolescent population. For this to happen, it is essential to release the measure by the Centers for Disease Control and Prevention (CDC), the body responsible for public health in the USA.
If the CDC approves the use of the vaccine in this group, immunization could start immediately, answering a question from tens of millions of American families who are trying to establish routines for their homes where only adults and teenagers from 16 years old until now have been vaccinated. It also represents the removal of the last obstacle to the reopening of schools.
How was the clinical study of teenagers?
The clinical study conducted by Pfizer-BioNTech with adolescents involved 2,260 participants aged between 12 and 15 years, who received two doses of the vaccine or a placebo, with a three-week interval between applications. Among the group that received the placebo, there were 18 cases of symptomatic coronavirus infection. No case occurred among the adolescents who received the immunizer.
In addition to its effectiveness, the vaccine also revealed a good safety profile, with side effects (usually fevers) occurring in 20% of the inoculated population, a value compatible with the 16-25 year old age group, according to Pfizer senior vice president, pediatrician Bill Gruber, who also highlights the immune response beyond expectations.
Two more studies are being conducted by Pfizer: one with children between 5 and 11 years old, and another in the range of 2 to 5 years old. There are still no results for these tests.