Written answers

Thursday, 9 September 2021

Department of Health

Vaccination Programme

Photo of Peadar TóibínPeadar Tóibín (Meath West, Aontú)
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1029. To ask the Minister for Health the risk-benefit analysis carried out by National Immunisation Advisory Committee, NIAC, with regard to the Covid-19 vaccination of the 12 to 15 years of age cohort. [41611/21]

Photo of Peadar TóibínPeadar Tóibín (Meath West, Aontú)
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1031. To ask the Minister for Health the long-term testing there has been on the vaccine and children as young as 12 years of age. [41613/21]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 1029 and 1031 together.

In clinical trials of children and young people aged 12-15 years in the case of Comirnaty® (Pfizer-BioNTech) and 12-17 years for Spikevax® (Moderna), the point estimate for efficacy of both vaccines was reported as 100% in these age groups. Reactogenicity occurred at a slightly higher frequency in these age groups compared to adults, but side effects from the vaccine were similar to those experienced by adults e.g. injection site pain, fatigue, headache. Vaccination in those 12-15 years is associated with short-lived, self-limited side effects.

The National Immunisation Advisory Committee considered the benefits and risks to this age group of receiving a COVID-19 vaccine, as well as the short and longer-term impacts of SARS-CoV-2 infection on children and young people in this age group and recommended that vaccination be extended to those aged 12-15 years. COVID-19 infections in those aged 12-15 years are usually asymptomatic or mild. Hospitalisation rates, rates of ICU admission are very low and death is rare. This does not exclude the possibility of severe COVID-19 developing, even in the previously healthy child. The risk of hospitalisation is higher in those with underlying chronic medical conditions and can approach that of older adults with risk conditions. NIAC also considered other potential risk factors for children and young people aged 12-15 years as a result of contracting SARS-Cov-2 COVID-19 including Multisystem Inflammatory Syndrome in Children (MIS-C) and long-COVID, as well as the psycho-social impact of COVID-19 on this age group.

The European Medicines Agency (EMA) has recommended granting an extension of indication to both Comirnaty and Spikevax to include use in children aged 12 years and older and has concluded that the benefits of Comirnaty and Spikevax in children and young people in this age group outweigh the risks, in particular in those with conditions that increase the risk of severe COVID-19.

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