As noted in the announcement, an evaluation of a separate application concerning the booster dose in adolescents aged 16 to 17 years is already underway.
It is recalled that a booster dose of this vaccine, i.e. a third dose after completion of the initial vaccination regimen to restore protection after it has weakened over time, has already been approved for persons over 18 years of age.
The EMA Committee for Medicinal Products for Human Use (CHMP) will proceed with an accelerated assessment of the data submitted, which includes data from actual use of the vaccine in Israel. The EMA will communicate the results of the evaluation in due course.
As the EMA recalls, recommendations on how vaccines should be administered remains the responsibility of the technical advisory committees for vaccination at national level, which guide vaccination campaigns in each Member State.
National public health authorities may issue formal recommendations on the use of booster doses and on their use in relation to the prerequisites for travellers, taking into account the emerging data on their efficacy and the limited data on safety.
The Comirnaty vaccine, the EMA recalls, contains messenger RNA (mRNA) with instructions to produce a protein, known as spike protein, naturally present in SARS-CoV-2, the virus that causes COVID-19. The vaccine works by preparing the body to defend itself against SARS-CoV-2.
Source: CNA
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