The European Medicines Agency (EMA) has announced that it has begun evaluating an application by BioNTech / Pfizer for a booster dose of the Comirnaty COVID-19 vaccine for adolescents 12 to 15 years of age.
As noted in the announcement, an evaluation of a separate application regarding the supportive dose in adolescents 16 to 17 years old is already underway.
It is reminded that it has already been approved for people over 18 years of age and a booster dose of this vaccine is given, ie a third dose after the completion of the initial vaccination regimen with the aim of restoring protection after its weakening over time.
The Committee for Medicinal Products for Human Use of the EMA (CHMP) will carry out an expedited evaluation of the data it has submitted, which includes data on the actual use of the vaccine in Israel. Coreper will communicate the results of the evaluation in due course.
As Coreper reminds us, recommendations on how vaccines should be administered remain the responsibility of technical vaccination advisory committees at national level, which guide vaccination campaigns in each Member State.
National public health authorities may issue formal recommendations for the use and utilization of booster doses in relation to traveler prerequisites, taking into account emerging data and limited data on the safety.
The Comirnaty vaccine, EMA recalls, contains messenger RNA (mRNA) with instructions for producing a protein known as spike protein, which is naturally present in the SARS-CoV-2 virus, the virus that causes COVID-19. The vaccine works by preparing the body to defend itself against SARS-CoV-2.
