Ema gives green light for Moderna vaccine for children 6-11 years old
Moderna vaccine for children 6-11 years old: dose will be lower than that used in people aged 12 years and older
The Ema’s Committee for Medicinal Products for Human Use has recommended extending the use of the Covid-19 Spikevax vaccine to children aged 6-11 years.
The vaccine, developed by Moderna, is already approved for use in adults and children aged 12 years and over
This was announced by the European Medicines Agency.
The dose of Spikevax in children aged 6-11 years will be lower than that used in people aged 12 years and older (50 µg compared to 100 µg).
As in the older age group, the vaccine is administered with two injections four weeks apart.
The most common side effects in children aged 6-11 years are similar to those seen in people aged 12 years and older. They include pain, redness and swelling at the injection site, fatigue, headache, chills, nausea, vomiting, enlarged or painful lymph nodes under the arm, fever and muscle and joint pain.
These effects are generally mild or moderate and improve within a few days after vaccination.
Evidence suggests that the efficacy and safety of the Spikevax vaccine in children aged 6-11 years are similar to those in adults
The Chmp therefore concluded that the benefits of Spikevax vaccine in this age group outweigh the risks, particularly in those with conditions that increase the risk of severe Covid-19.
The EMEA informs that it will continue to closely monitor the safety and efficacy of the vaccine in children and adults as it is used in vaccination campaigns in EU Member States through the EU pharmacovigilance system and ongoing and additional studies conducted by the company and European authorities.
The Chmp will now send its recommendation to the European Commission for a final decision.
EMA: “GREEN LIGHT FOR THIRD DOSE OF PFIZER VACCINE FOR OVER-12”
The EMEA’s Committee for Medicinal Products for Human Use has given the go-ahead for the administration, when deemed appropriate, of the third dose of the Covid-19 vaccine Comirnaty (Pfizer-BioNTech) to adolescents aged 12 and over.
This was announced by the European Medicines Agency. Comirnaty is already authorised in the EU as a 2-dose primary course in adolescents, as well as for adults and children aged 5 years and over, and a booster dose is currently authorised from 18 years of age.
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