Paul-Ehrlich-Institut

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CHMP at EMA rec­om­mends Mar­ket­ing Au­tho­ri­sa­tion Ex­ten­sion for BioN­Tech/Pfiz­er’s COVID-19 Vac­cine Comir­naty for Chil­dren aged 12 to 15

On 28 May 2021, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) recommended that the COVID-19 vaccine Comirnaty from BioNTech/Pfizer is to be granted a marketing authorisation extension for the EU and thus also for Germany. Up to now, the vaccine has been approved for persons aged 16 years and older. With the authorisation extension, this vaccine can be used from the age of 12 years. A decision by the European Commission is expected in the near future, which will generally follow the recommendations of the CHMP.

Ampoules of vaccine comirnaty and syringe (Source: Squarespace/Pixabay.com)

In a randomised, placebo-controlled clinical trial of slightly more than 1,000 Comirnaty-vaccinated adolescents aged 12 to 15 years, the primary study objective was to demonstrate that immunogenicity (measured as neutralising antibodies to SARS-CoV-2) is produced after two vaccinations of 12- to 15-year-olds at the same or even higher titers as in 16- to 25-year-old adults. As a secondary study objective, efficacy against COVID-19 was shown to be in a very similar range to adults (efficacy 100%, 95% CI 75,100). Therefore, this COVID-19 vaccine can be expected to prevent COVID-19 of any severity and all illnesses associated with and following SARS-CoV-2 infection (e.g. Pediatric Inflammatory Multisystem Syndrome (PIMS), Long-COVID) with a high probability even in adolescents aged 12 to 15 years. Formal evidence to demonstrate prevention of these beneficial effects cannot be provided, as a repeat randomised trial in a subgroup would not be appropriate. It can also be assumed that the overall direct benefit in terms of prevention of COVID-19 is higher in adolescents with risk factors for a symptomatic or severe course than in adolescents without risk factors.

Analysis of common adverse events (reactogenicity, typical transient vaccine reactions) revealed a profile similar to that observed in adults. Overall, the frequency of occurrence of this adverse event was slightly higher than in adults, but neither qualitatively new nor new serious adverse events were observed. Serious adverse events were observed in 0.4% of vaccinated subjects and 0.2% of subjects receiving placebo. None of these events were attributed to the vaccine. As with any authorisation, information on the occurrence of rare adverse events is limited, but the very large database in adults due to the millions of vaccinations already administered supports the safety of Comirnaty. The recently observed signal of heart muscle inflammation (myocarditis) in young adults is under active investigation; it is not clear whether these observations are causally related to vaccination with Comirnaty. No case of myocarditis was observed in the study in adolescents. Experience from the United States, which has already granted approval for adolescents < 16 years of age, is insufficient to draw conclusions at this time.

For the use of a vaccine, in addition to the direct medical benefit for the vaccinated person, i.e. the prevention or mitigation of the disease and the consequences of the disease, the indirect and, if applicable, the social or socio-psychological benefit must also be taken into consideration. These indirect benefits cannot be examined in registration studies, but must be considered in the context of the impact of the infectious event on the population. In the context of a European authorisationl, it must be taken into account that this context may be different in the member states. This concerns, for example, the measures taken to contain the incidence of infection, such as distancing measures, the resulting psychological and social consequences, the economic conditions, such as the possibility of working from a home office or teaching by computer, and the general acceptance of the various measures in the population, but also the vaccination strategy as a whole.

In the overall view of the collected data on proven direct benefits, possible or probable indirect benefits, and known risks, there is a favorable risk-benefit balance. The best allocation is to be made by the member states depending on the vaccination strategy. In Germany, such considerations are made either politically or by the Standing Commission on Vaccination (Ständige Impfkomission, STIKO).

Updated: 28.05.2021