THE EU's medicines agency has announced today that it has approved the use of the Covid Moderna vaccine for children aged 12 to 17 years.
The use of the Moderna jag – now known as Spikevax – will be the same as for over 18s for which it has already been approved.
It is given as two injections in the muscles of the upper arm, four weeks apart.
In a statement this afternoon the agency said the effects of Spikevax were investigated in a study involving 3732 children aged 12 to 17 years.
It 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.
READ MORE: Nicola Sturgeon says vaccinating over-12s should not be ruled out
In addition, none of 2163 children receiving the vaccine developed Covid-19 compared with four of 1073 children given a dummy injection. These results allowed the researchers to conclude that the efficacy of Spikevax in 12 to 17-year-olds is similar to that in adults.
The most common side effects in children aged 12 to 17 are similar to those in people aged 18 and above. They include pain and swelling at the injection site, tiredness, headache, muscle and joint pain, enlarged lymph nodes, chills, nausea, vomiting and fever. It said the effects were usually mild or moderate and improved within a few days from the vaccination.
The researchers noted 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).
READ MORE: Global health expert calls for vaccine for all Scottish high school pupils
However, the overall safety profile of Spikevax determined in adults was confirmed in the adolescent study. It concluded that the benefits of Spikevax in children aged 12 to 17 outweigh the risks, in particular in those with conditions that increase the risk of severe Covid-19.
The development comes days after the UK's Joint Committee on Vaccination and Immunisation (JCVI) advised against offering the Pfizer jab to 12 to 17 year olds, despite the UK medicines regulator Medicines and Healthcare products Regulatory Agency approving its use on safety grounds for 12 to 17 year old in June.
The Scottish Government is following the recommendation of the JCVI and is only offering the vaccine to a limited number of over 12s including those with certain serious health conditions.
However, the World Health Organisation recommend vaccinating children with many parts of the world including the US and France already offering jags to over 12s.
Many leading doctors and public health experts in the UK abelieve children over 12 should be vaccinated.
They include Professor Devi Sridhar, a Scottish Government advisor, and Professor Anthony Costello, a former WHO director who sits on the independent Sage panel.
First Minister Nicola Sturgeon could overrule JCVI advice to withhold vaccines from adolescents and adopt the child vaccination programme recommended by the World Health Organisation (WHO) instead.
She said earlier this week that she would not rule out vaccinating over 12s and that the Chief Medical Officer Gregor Smith was writing to the JVCI to get further details of their report.
Ahead of the publication of the JCVI advice Dr Deepti Gurdasani, a clinical epidemiologist at Queen Mary University of London, said she would be extremely disappointed if children were denied a vaccine in the general population.
She told the BBC: “I am terrified for our children. The way we are going actually requires children to get infected and develop...herd immunity by infection rather than get vaccinated.
“More than six million children in the US alone have been vaccinated, but we have decided that it is safer to expose children to a virus that causes long Covid, with 9000 of our children already having long Covid for more than a year. I cannot tell you how reckless, unethical and crazy that is."
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