The EMA Committee for Medicinal Products for Human Use (CHMP) has recommended that a booster dose of Comirnaty vaccine for COVID-19 disease, where deemed appropriate, may be given to adolescents from 12 years of age. Comirnaty is already licensed in the EU as a 2-dose initial vaccination regimen in adolescents (as well as in adults and children from 5 years of age) and the booster dose of the vaccine is currently licensed for persons aged 18 years and over.
The CHMP opinion follows an assessment of preliminary safety and efficacy data from a booster dose clinical trial of the vaccine in people aged 16 years and older, as well as relevant published literature and post-marketing data combined with real-world evidence from the use of booster doses in young recipients in Israel.
The administration of booster doses to vaccinated individuals (i.e., individuals who have completed their initial vaccination) is applied to restore protection after it has waned. The Commission considered that the available data were sufficient to conclude that the immune response to a booster dose in adolescents would be at least equivalent to that in adults. No new safety issues were identified from the available data.
Further data are expected from studies and analyses in adolescents in the coming months. The EMA will continue to monitor and evaluate the data and update the product information or take other appropriate regulatory action as necessary.
The Agency's decision will support national vaccination campaigns in those Member States that decide to offer booster vaccinations to adolescents. However, the decision on whether and when to offer booster doses to this age group should take into account factors such as the spread and potential severity of the disease (especially with the Omicron variant) in younger individuals, the known risk of side effects (in particular the very rare but serious complication of myocarditis) and the existence of other protective measures and restrictions. As with previous vaccination decisions, it will therefore be up to the experts leading the vaccination campaigns in each Member State to advise on the optimal decision and timing for their country.
The CHMP opinion will now be forwarded to the European Commission, which will issue a final decision shortly.
Comirnaty is a vaccine for the prevention of COVID-19 disease. This vaccine 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. The vaccine works by preparing the body to defend itself against SARS-CoV-2. More information about the vaccine is available here.
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