The EMA started evaluating an application for a booster dose of Comirnaty vaccine (BioNTech/Pfizer vaccine) in adolescents aged 12 to 15 years. An application for adolescents aged 16 to 17 years is also in progress.
Booster doses are given to vaccinated persons (i.e. persons who have completed their initial vaccination) so that protection is restored if protection is impaired. Currently, the booster dose of Comirnaty may be given to people aged 18 years and over.
The EMA Committee for Medicinal Products for Human Use (CHMP) will conduct a rapid assessment of the data submitted by the company marketing Comirnaty, including results from real-world data from Israel. The EMA will communicate the outcome of the evaluation in due course.
Recommendations on how vaccination should be carried out remain the prerogative of the national vaccination technical advisory groups that guide vaccination campaigns in each EU Member State. National public health bodies may issue formal recommendations on the use of booster doses and related travel certification requirements, taking into account emerging efficacy data and limited safety data.
Comirnaty is a vaccine for the prevention of COVID-19 disease. It contains a molecule called messenger RNA (mRNA) with instructions to produce a protein, known as spike protein, that is naturally present in SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine works by preparing the body to defend itself against the SARS-CoV-2 virus. More information about the vaccine is available here.
(AF)
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