The European Medicines Agency (EMA) is recommending the approval of the use of the BioNTech / Pfizer Comirnaty vaccine against COVID-19 for children 5 to 11 years old, according to a statement issued on Thursday.
Coreper, which is the Committee of the Permanent Representatives of the Governments of the Member States to the European Union, suggests that a lower dose of 10 mg be given to children 5 to 11 years of age rather than the 30 mg dose already given to persons over 12 years of age. They also suggested that both shots be given within 3 weeks of the other.
According to a study cited by Coreper, the immune coverage provided by a dose of this size between the ages of 5 and 11 is similar to that given to people between the ages of 16 and 25.
The efficacy of the vaccine was analyzed based on the results of the vaccination of 2 thousand children between 5 and 11 years of age for whom there was no evidence of being infected with the coronavirus in the past.
Specifically, three of the 1305 children who received the vaccine developed COVID-19 compared with 16 of the 663 children in the placebo-controlled group. According to these data, the vaccine was found to be 90.7% effective in preventing COVID-19 symptoms (although it is noted that the actual rate may be between 67.7% and 98.3%).
The most common side effects in children 5 to 11 years old are similar to those seen in people over 12, and include vaccination pain or redness, fatigue, headache, muscle aches and chills. These side effects are usually mild or moderate and go away after a few days.
Therefore, the EMA's Committee for Medicinal Products for Human Use (CHMP) found that the benefits of this vaccine for children 5 to 11 years of age outweigh the risks, especially for people with conditions that increase the risk of serious coronavirus disease.
As noted, the safety and efficacy of the vaccine in children and adults will be continuously evaluated as it continues to be used in vaccination programs in EU Member States, through the EU pharmacovigilance system and through ongoing and additional studies.
The CHMP will forward its proposal to the Commission which will take the final decision.