What did Ema decide on the over 12 booster and Moderna for children
The EMA recommends the administration of the booster dose in adolescents "where necessary" and authorizes the Moderna vaccine in children between 6 and 11 years of age. All the details
The European Medicines Agency (EMA) recommends the administration of the booster dose with the Pfizer / BioNTech vaccine also for children aged 12 and over and to extend the use of Moderna to children between 6 and 11 years of age.
The decision and timing of the third dose for adolescents, however, will be up to the respective experts who lead the vaccination campaign in each Member State.
DOSE BOOSTER OVER 12 "WHEN NECESSARY"
The Committee for Medicinal Products for Human Use (Chmp), reads a note released by the EMA, recommends the administration "where necessary" of the booster dose with the Comirnaty vaccine [Pfizer / BioNTech, ed ] in adolescents from 12 years of age . Until now it had only been authorized for the over 18s.
The booster doses, the Agency recalls, are administered to people who have completed the primary course to restore protection after it begins to wane.
SO WHO DECIDES?
The EMA has made it known that "it will support national vaccination campaigns in those Member States that decide to offer booster vaccinations to adolescents". However, the Agency writes, “the decision as to whether and when to offer boosters in this age group will have to take into account factors such as the spread and likely severity of the disease (especially with the Omicron variant) in younger people, 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 decisions on vaccination, – concludes the note – it will therefore be up to the experts who lead the vaccination campaign in each Member State to advise the decision and the optimal times for their country".
I STUDY
The CHMP made the decision based on provisional safety and efficacy data from a clinical study on the booster dose in adolescents aged 16 and over, combined with published literature and post-authorization data, as well as evidence from the real world from Israel.
Further data are expected in the coming months. Meanwhile, EMA will continue to monitor and evaluate tests and update product information.
OK A MODERN FOR THE 6-11 YEARS BAND
On the same day, the EMA also recommended the use of Spikevax, Moderna's vaccine, for children aged 6 to 11. Until now, in the EU countries, the only one to be authorized in this age group was that of Pfizer / BioNTech and Moderna had received the ok from 12 years upwards.
The dosage of Spikevax in children will be lower than that used for children aged 12 and over (50 µg versus 100 µg). As in other age groups, the vaccine is given as two injections four weeks apart.
I STUDY
A study in children 6 to 11 years old showed that the immune response at the lowest dose was comparable to that seen with the highest dose in people 18 to 25 years old.
The most common side effects in children aged 6 to 11 are similar to those that have occurred aged 12 and over. Pain, redness and swelling at the injection site, fatigue, headache, chills, nausea, vomiting, swollen lymph nodes under the arm, fever, and muscle and joint pain. These effects are usually mild or moderate and improve within a few days of vaccination.
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/cosa-ha-deciso-ema-sul-booster-over-12-e-su-moderna-per-i-bambini/ on Fri, 25 Feb 2022 11:08:18 +0000.