EMA has started the evaluation of an application for the use of a booster dose of Comirnaty (BioNTech/Pfizer vaccine) in adolescents aged 12-15 years. An application for adolescents aged 16-17 years is also in progress.
An accelerated assessment of the data submitted, including data from real-life outcomes in Israel, by the CHMP, the Committee for Medicinal Products for Human Use of EMA (European Medicines Agency), is expected.
Comirnaty is a vaccine for the prevention of COVID-19. It contains messenger RNA (mRNA), a molecule that contains instructions to produce the spike protein, which is 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.
Booster doses are given to vaccinated people to restore protection after it has waned.
Why is a booster dose needed?
Boosters are useful to prevent a decline in immunity against COVID-19. They restore protection against infection and disease and help to achieve high levels of antibody in adults.
Current vaccines offer less protection against infection and mild disease caused by the Omicron variant. However, vaccination continues to offer considerable protection against hospitalisation and severe forms of COVID-19 with Omicron, especially after a booster dose. A booster dose is therefore necessary to prolong vaccine protection.
Data on booster dose in adolescents
Preliminary results suggest an increase in the effectiveness of the SARS-CoV-2 vaccine in adolescents. However, few data are currently available.
For the management of paediatric populations, the EMA and its European Paediatric Committee (EPC) carry out a partial extrapolation between adult and paediatric populations.
The adolescent booster dose in the EU
At present, at EU level, booster doses are only allowed to be given to people aged 18 years and above.
Recommendations on the use of booster doses at national level remain the prerogative of Member State public health bodies.
The booster dose for adolescents in France
In France, since 24 January 2022, the vaccine booster is open to all people aged 12 years and over.
This booster is not compulsory, but it is recommended because of the high contagiousness of the Omicron variant, which also affects this age group.
The administration of a booster dose in adolescents aged 12 to 17 years only concerns the Pfizer vaccine (Comirnaty) as the HAS ( the French National Authority for Health) does not recommend the use of the Moderna vaccine (Spikevax) in adults under the age of 30 years in France.
The administration of multiple booster doses of COVID-19 vaccine in the short term is not a viable long-term approach. It is therefore necessary to develop a long-term strategy on the types of vaccines needed to manage COVID-19 in the future.