EU medicines agency approves Moderna COVID-19 vaccine for youths aged 12 to 17

The European Medicines Agency (EMA) has authorised use of the Moderna vaccine among youths aged 12 to 17 years old, to be given as two injections four weeks apart.

The vaccine is already authorised for use in people aged 18 and above, but will be extended for use among everyone above 12 years of age.

In Malta, the Pfizer vaccine is the only jab being administered to the 12-15 age group. 

The effects of the Moderna vaccine were investigated in a study involving 3,732 children aged 12 to 17 years. It is an ongoing study that is being carried out in accordance with the company's paediatric investigation plan, as agreed by EMA's Paediatric Committee (PDCO).

The study found that Moderna produced a comparable antibody response in this age group to that seen in young adults aged 18 to 25 years. In addition, none of the 2,163 children receiving the vaccine developed COVID-19, while four children from the separate control group ended up contracting the virus.

This led EMA's human medicines committee to conclude that the vaccine's efficacy in 12- to 17-year-olds is similar to that in adults.

The most common side effects developed during the trial included pain and swelling at the injection site, tiredness, headache, muscle and joint pain, enlarged lymph nodes, chillds, nausea, vomiting and fever.

These effects are usually mild or moderate and improve within a few days from the vaccination, similar to those in people aged 18 and above.

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).

Despite this, the committee determined that the benefits of the Moderna vaccine in the 12-17 age group outweigh the risks, especially among those with conditions that increase the risk of sever COVID-19.

The agency said that the vaccine's safety and efficacy, both in children and adults, will continue to be monitored closely as it is used in vaccination campaigns across the EU.

The authorisation comes after the European Centre for Disease Prevention and Control (ECDC) show that the Delta variant has become dominant in 19 out of 28 countries. 

In Malta however, only 64 cases of the Delta variant have been registered.

172 new cases of COVID-19 were registered on Friday, as Malta grapples with a fourth wave of high cases. 19 patients are currently being treated at Mater Dei Hospital, one of whom is being treated in the ITU.