Covid vaccine approved for children as young as 12 

Covid vaccine approved for children as young as 12 

The Department of Health announced the figures as the Moderna vaccine has been approved for use in the EU for children aged 12 to 17.

Health officials confirmed a further 1,386 cases of Covid-19 in Ireland as a vaccine was given European approval to be given to children as young as 12. 

The Department of Health announced the figures as the Moderna vaccine was approved for use in the EU for children aged 12 to 17.

The European Medicines Agency (EMA) said that its human medicines committee (CHMP) has recommended granting an extension of indication for the Spikevax jab (previously Covid-19 Vaccine Moderna) to include use in children aged 12 to 17 years.

It has already been authorised for people aged 18 and over.

The EU’s health regulator said that the vaccine will be used for children aged 12 to 17 the same way as it is used for adults.

“It is given as two injections in the muscles of the upper arm, four weeks apart,” the EMA said.

The effects of the Spikevax jab were investigated in a study of 3,732 children aged 12 to 17 years.

 

“The study showed that Spikevax produced a comparable antibody response in 12- to 17-year-olds to that seen in young adults aged 18 to 25 years (as measured by the level of antibodies against SARS-CoV-2),” said a statement.

“In addition, none of 2,163 children receiving the vaccine developed Covid-19 compared with four of 1,073 children given a dummy injection.” 

The efficacy of the jab in those aged 12 to 17 is similar to that in adults.

The EU’s health regulator said that the Moderna vaccine will be used for children aged 12 to 17 the same way as it is used for adults.
The EU’s health regulator said that the Moderna vaccine will be used for children aged 12 to 17 the same way as it is used for adults.

The EMA said that the most common side effects were also similar.

They included pain and swelling at the injection site, tiredness, headache, muscle and joint pain, enlarged lymph nodes, chills, nausea, vomiting and fever.

The EMA did note that “due to the limited number of children and adolescents included in the study, the trial could not have detected new uncommon side effects or estimated the risk of known side effects such as myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart).

“However, the overall safety profile of Spikevax determined in adults was confirmed in the adolescent study.” 

The EMA said that the benefits of the jab for children aged 12 to 17 outweigh the risks, “in particular in those with conditions that increase the risk of severe Covid-19”.

It added that the safety and efficacy of the jab in both children and adults will “continue to be monitored closely”.

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