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Com­mit­tee for Medic­i­nal Prod­ucts for Hu­man Use at the EMA rec­om­mends ex­tend­ing au­tho­ri­sa­tion of Mod­er­na's COVID-19 vac­cine Spike­vax for those aged 12 and over

On 23 July 2021 the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) stated its recommendation for the marketing authorisation of Moderna’s COVID-19 vaccine Spikevax to be extended within the EU and hence also Germany. Thus far, the vaccine has been approved for those aged 18 and over, but with the approval extension this vaccine can now be used for those aged 12 and over. The European Commission decided to follow the CHMP recommendation at the same day.

Vaccine Moderna (Spikevax) ampoules and syringe (Source: pcruciatti/shutterstock.com)

A randomized, placebo-controlled clinical trial involving 3,732 children and young people aged between 12 and 17 demonstrated as its primary objective that immunisation (measured as neutralizing antibodies against SARS-CoV-2) produced comparable (“non-inferior”) titres to those in young adults following double vaccination in this age group. It can therefore be assumed that this COVID-19 vaccine prevents COVID-19 of any severity and with a high level of probability in children and young people aged 12 to 17, too. This also applies to all the disorders and sequelae associated with a SARS-CoV-2 infection, such as Paediatric Inflammatory Multisystem Syndrome (PIMS) and long COVID. Formal evidence to demonstrate the prevention of these effects cannot be derived from the study. A new, randomized trial within this subgroup would not be appropriate, since this would again require use of a placebo. Only a few cases of COVID-19 occurred overall in the study, namely none within the group of 2,163 double-vaccinated children and adults compared to four cases in 1,063 participants who received placebo injections.

The analysis of common side-effects (reactogenicity, typical transient vaccination reactions) showed a similar profile as in adults. Neither more intense manifestations of known side effects nor new serious side effects were observed.

Serious adverse events were observed in 0.2 % of vaccinated subjects and subjects receiving the placebo. None of these events were traced back to the vaccine. The benefit-risk profile of Spikevax proved positive in this age group, too.

As with any marketing authorisation, information on the occurrence of rare side-effects is limited, but the very broad basis of data thanks to the millions of vaccinations already administered in adults supports the safety of Spikevax. In young adults, there have been very rare reports of cases of heart muscle inflammation (myocarditis) and inflammation of the pericardium (pericarditis). In the study of children and young people, no cases of myocarditis or pericarditis were observed, although the small number of participants means that no fundamental statement can be made about new occasional side-effects or about the risk of these known side-effects in the age group studied.

For the application of a vaccine, it is important to take into account not only the direct medical benefit for the vaccinated person, i.e. the prevention or mitigation of the disease and consequences of the disease, but also the indirect and, if applicable, the social or socio-psychological benefit. This indirect benefit cannot be reviewed in marketing authorisation studies, but rather must be considered in relation to the effects of the infection on the population. In the context of a European authorisation, the fact that such a context can vary among the member states must be taken into account. 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 home or lessons at the computer, and the general acceptance of the various measures among the population, but also the vaccination strategy as a whole. The recommendation regarding which age groups should be vaccinated against COVID-19 is made by the Standing Commission on Vaccination (STIKO).

Decisions on use of the vaccine are made by the member states depending on their respective vaccination strategies.

Updated: 23.07.2021