Auf unsere Nachfrage an die EMA (Europäische Arzneimittel-Zulassungsbehörde), ob Empfehlungen zu einem off labe use gegeben werden könne, haben wir folgende Antwort erhalten:
„Die EMA kann weder Empfehlungen noch Kommentare zu einem off-label-use der Impfstoffe abgeben, weil ihr dazu noch keine ausreichenden Nachweise vorgelegt wurden, um einen off-label-use zu befürworten.“
Die vollständige Antwort auf Englisch finden Sie hier:
Thank you for your enquiry from 8 April regarding the off-label use of COVID-19 Vaccines in children.
Before a company can apply for marketing authorisation of a COVID-19 vaccine, EMA will have to agree with the company plans for studies in children (paediatric investigational plans or PIPs). EMA has put in place a [rapid procedure|https://www.ema.europa.eu/en/human-regulatory/research-development/paediatric-medicines/paediatric-investigation-plans] for approving these plans to avoid delays when companies apply for marketing authorisation.
The marketing authorisation to paediatric populations is granted by the Committee for Human Medicinal Products (CHMP) once data submitted from the trials that were agreed with the Paediatric Committee at EMA (PDCO) in the PIPs show that the vaccine is safe and efficacious in children.
The clinical trials contained in the PIP generally foresee that the vaccines will be first tested in adolescents and then progressively in children below 12 years of age down to the youngest ages. For this reason, it is assumed that the first data that will be submitted for marketing authorisation in the paediatric age groups will be those of adolescents from 12 years of age.
As soon as data in one age group show that the vaccine is safe and presents a good immune response, developers can submit the data to the EMA for a marketing authorisation in that age group. In addition, clinical trials may include an analysis after a certain number of children have been studied, and if the data are very good, interim trial results can be submitted earlier for assessment by CHMP.
It is not known at the moment when these data will be submitted because the studies are still ongoing. As things stand, the first two authorised mRNA vaccines have recruited adolescents at a fast pace into their clinical trials (this information is publicly available on the web: [https://cen.acs.org/pharmaceuticals/vaccines/COVID-19-vaccine-trials-kids/99/i10]
The first results in adolescents are expected to become available in late spring. In the meantime, the clinical trials are also starting progressively in children below 12 years of age.
Once the data are available and developers submit them to the EMA, the length of the review and therefore the date of authorisation for the use of these vaccines first in adolescents, and subsequently in younger children, will depend on the level and quality of information that needs to be evaluated, but the review will follow an expedited route as for all regulatory activities related to COVID-19.
With regards to the off-label use of COVID-19 vaccines in children, EMA cannot offer advice or comment on the ‘off-label use’ because the Agency has not seen evidence that allows it to support such use yet.
We are sorry we could not be of more help on this occasion. However, we would be grateful if you could take part in a short survey on our service, which you can access through the following link: [https://ec.europa.eu/eusurvey/runner/AskEMA]