Lima, November 25, 2021Updated on 11/25/2021 09:33 am
The European Medicines Agency (EMA) supported on Thursday the extension of the current European license of the pharmaceutical companies Pfizer and BioNTech for the use of their vaccine against COVID-19 in children between 5 and 11 years old, although with a dose lower than the one used in people over 12 years old.
The injection will be administered in two doses, with an interval of three weeks between the first and the second, underlines the agency in a statement, in which it notes that the benefits of vaccinating with Pfizer children in that age group outweigh the risks.
This conclusion, reached today by the Committee for Medicinal Products for Human Use (CHMP), will be sent immediately to the European Comission, which is the one that has the last word on the licensing of authorized vaccines in European campaigns.
The most common side effects found in clinical trials were similar to those in those 12 years of age and older, including tiredness, muscle and headache pain, chills, soreness, and redness at the injection site – effects that are usually “mild to moderate” and they improve a few days after vaccination.
The main study of nearly 2,000 children ages 5 to 11, with no signs of prior infection, showed that “Immune response to Comirnaty (the commercial name of the vaccine), administered at a lower dose in this age group, was comparable to that observed with the highest dose in people aged 16 to 25 years, based on the level of antibodies” against him coronavirus.
“The vaccine was 90.7% effective in preventing the COVID-19 symptomatic (although the real rate could be between 67.7% and 98.3%) “, stresses the agency.
The of Pfizer It is the first vaccine that receives support from European scientists to be administered in children under 11 years of age, although the Moderna pharmaceutical company also requested the EMA evaluate the possible use of its vaccine in children aged 6 to 11 years, which is still being studied by the CHMP.