Europe's medicines regulator has recommended approving the use of Moderna's Covid vaccine in 12- to 17-year-olds, paving the way for it to become the second shot approved for adolescent use in the European Union.
The use of the vaccine will be the same in adolescents as in people above 18 years, the European Medicines Agency (EMA) said, adding the vaccine produced a comparable antibody response to that seen in 18- to 25-year olds.
Vaccinating children has been considered important for reaching herd immunity against Covid-19 and in light of the highly contagious Delta variant.
In May, Moderna said its vaccine was found to be safe and effective in teenagers.
EMA's safety committee said while common side effects in teenagers after vaccination were similar to those seen in older populations, due to a smaller study size, the trial could not detect new uncommon side effects or estimate the risk of known ones such as myocarditis and pericarditis.
The Moderna jab employs the same mRNA technology as Pfizer/BioNTech, using genetic material to deliver instructions to human cells to create coronavirus spike proteins.
It thereby trains an immune response without exposing the host to a real infection.
The EMA said there were common side effects in children similar to those in adults.
This included pain and swelling at the injection site, tiredness, headache, muscle and joint pain, enlarged lymph nodes, chills, nausea, vomiting and fever.
"These effects are usually mild or moderate and improve within a few days from the vaccination," the EMA said.
'Benefits outweigh risks'
But it 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".
Nor could it estimate 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," it said.
"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 EU yesterday said 200 million Europeans have been fully vaccinated, more than half of the adult population, but still short of a 70% target it had set for the summer.
The EU's rollout began more slowly than in Britain and the United States - largely because of supply shortages - and drew heavy criticism during the first months of the year.
The European Commission, which coordinated vaccine orders for the 27 member states, was the subject of many of the complaints.
European Commission chief Ursula von der Leyen had announced on 10 July that the EU had enough doses to vaccinate "at least 70% of the adult population this month".
According to official data compiled by AFP, just over 440 million doses have been administered in the European Union. That is 98.4 doses per 100 inhabitants, while the United States are at 102.4 per 100 inhabitants.
Professor Brian MacCraith, who chairs the high-level task force on Covid-19 vaccination, described the EMA approval as "another important development with possible implications for our rollout programme".
Another important development with possible implications for our rollout programme.— Brian MacCraith (@muirtheimhne) July 23, 2021
EMA approves Moderna vaccine for 12-17 year olds. https://t.co/gVKrlzF9Ak
In May, the EMA approved the Pfizer/BioNTech vaccine for use in 12 to 15-year-olds.
For the vaccine rollout to reach younger teenagers here as approved by the EMA, the Government would first need updated advice from the National Immunisation Advisory Committee (NIAC). All adults aged 18 and over are now eligible to register for a Covid-19 vaccine.