The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has decided, in an extraordinary meeting held a few hours ago, to give the go-ahead to the Pfizer vaccine for children 5 to 11 years old against COVID19.

As just reported in a statement, the dose of the Pfizer vaccine for children will be lower than that used in those over 12 years of age (10 ug versus 30 ug), and as in the older age group, it is administered in two injections into the muscles of the upper arm, three weeks apart.

Pfizer’s vaccine for children has more benefits than risks

After analyzing the studies provided by the company, the CHMP concludes that the benefits of Pfizer’s “Comirnaty” vaccine in children aged 5 to 11 years outweigh the risks, “particularly in those with conditions that increase the risk of severe of COVID19 ”. Therefore, the CHMP will now send its recommendation to the European Commission, which will issue a final decision.

This decision comes amid a large increase in COVID19 cases in 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 vaccine.

Pfizer’s vaccine for children has been licensed in infants ages 5 to 11 in the United States for nearly a month. According to data published by the US Food and Drug Administration (FDA), the vaccine was 90.7 percent effective in preventing COVID19 in this age group.

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The Committee has based its approval on a study in children aged 5 to 11 years, which showed that the immune response to “Comirnaty” administered at a lower dose (10 ug) in this age group was comparable to that observed with the highest dose (30 ug) in 16 to 25 years. The efficacy of the Pfizer vaccine for children was estimated in nearly 2,000 infants ages 5 to 11 who had no signs of prior infection. These children received either the vaccine or a placebo (a dummy injection).

Side effects are the same as in the adult vaccine

Of the 1,305 children who received the vaccine, three developed COVID10 compared to 16 of the 663 children who received placebo. This means that, in this study, the vaccine was 90.7% effective in preventing symptomatic COVID19.

The most common side effects of the Pfizer vaccine for youngsters are similar to those for people 12 years of age and older. These include pain at the injection site, tiredness, redness and swelling, headache, muscle pain, and chills. These are mild or moderate effects and improve within a few days of vaccination.

Regarding the safety and efficacy of the vaccine, both in children and adults, the EMA body indicates that it will continue to monitor closely, since it is used in vaccination campaigns in the EU Member States to through the EU pharmacovigilance system and ongoing and additional studies carried out by the company and the European authorities.