The European Medicines Agency (EMA) on Thursday approved the extension of the current license granted to pharmaceutical companies Pfizer and BioNTech to use the vaccine they developed against Covid-19 in children aged five to 11 years.
The immunizing agent will be applied in two doses, with an interval of three weeks between the first and the second, highlights a statement issued today by the EMA. According to the agency, the benefits of vaccinating this group of children outweigh any possible risks.
The conclusion, made by the Committee on Medicines for Human Use (CHMP) of the body, will be forwarded to the European Commission, which has the final word on the license of vaccines authorized in campaigns in the continental bloc.
According to clinical tests, the reactions detected were the same as those identified among people over 12 years old, that is, tiredness, muscle pain, headache, chills, malaise and stiffness at the injection site.
Studies classify these side effects as “mild and moderate”, which disappear a few days after vaccination.
The main test was carried out with almost 2,000 children, aged 5 to 11 years, with no signs of previous infection, and showed that the “immune response observed with a lower dose in this age group was comparable to that observed with a higher dose given to people 16 to 25 years, based on antibody level”.
“The vaccine was 90.7% effective in preventing symptomatic Covid-19 (although the actual rate could be between 67.7% and 98.3%),” indicates a statement issued by the EMA.
The immunizing agent developed by the Pfizer/BioNTech alliance was the first to receive authorization from European experts for application in children. The pharmaceutical company Moderna has requested a license for use in children aged between six and 11 years, in a process that is under analysis.
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