The European Medicines Agency (EMA) approved Pfizer’s coronavirus vaccine on Thursday for children between 5 and 11 years old, although with a lower dose than that used in people over 12 years of age.
With the approval of the European regulator, the continent thus joins USA, which recently licensed the vaccine for this age group. Canada, Israel, China and Saudi Arabia they also gave the green light to the preparation.
The injection will be given in two doses, with an interval of three weeks between the first and the secondThe agency stressed in a statement, in which it noted that the benefits of vaccinating children in that age group with Pfizer outweigh the risks.
According to data published by the U.S. Food and Drug Administration (FDA), the vaccine had a 90.7% effective in preventing COVID-19 in children between 5 and 11 years old.
The most common side effects detected 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.
The EMA’s decision comes amidst a large increase in COVID-19 cases across Europe, mainly due to the low vaccination coverage in some countries and because the group of children under 11 years of age has not yet been able to receive the inoculant.
The Pfizer vaccine is approved for use in the European Union (EU) in adolescents between 12 and 17 years of age since May.
Although the final approval depends on the European Commission, it usually follows the recommendations of the EMA.
It is not clear when countries will be able to start giving vaccines to the youngest children between the ages of 5 and 11. Earlier this week, Germany’s outgoing Health Minister Jens Spahn said EU-wide deliveries of the low-dose pediatric version would not start until December 20th.
Tens of millions of children in this age group will be able to receive the preparation in the EU.
Pfizer’s is the first vaccine to be endorsed by European scientists to be administered in children under 11 years of age, although the Pharmaceutical Moderna also asked the EMA to evaluate the possible use of its trial in children aged 6 to 11 years, which is still being studied by the Committee for Medicinal Products for Human Use (CHMP ).
(With information from EFE, Reuters and AFP)