The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for Moderna’s Covid-19 vaccine, Spikevax, for adolescents aged 12 to 17 years.
Spikevax is a messenger ribonucleic acid (mRNA) vaccine which is designed to encode a prefusion stabilised form of the Spike (S) protein from the SARS-CoV-2 virus.
It has already secured conditional marketing authorisation from the European Commission for active immunisation to prevent Covid-19 in adults aged 18 years and above in January this year.
Moderna stated that the EMA authorised Spikevax as the trade name for the Covid-19 vaccine.
Moderna CEO Stéphane Bancel said: “The CHMP recommendation of the authorisation of our Covid-19 vaccine for use in individuals 12 years of age and older in the European Union is a positive step forward toward authorisation of our vaccine in this age group.
“As we help to combat the pandemic, we hope to be able to help get adolescents safely back to school this fall.”
The effects of the Spikevax vaccine have been analysed in an ongoing Phase II/III study conducted in nearly 3,732 children aged 12 to 17 years in the US.
As per the data from the trial, the vaccine produced a comparable antibody response against SARS-CoV-2 in adolescent subjects as seen in young adults aged 18 to 25 years.
Additionally, it is noted that none of the children receiving Moderna’s Covid-19 vaccine developed Covid-19, while four of them received a dummy vaccine.
EMA stated that the most common side effects in subjects aged 12 to 17 years are similar to those in adults aged 18 and above.
Using the Phase II/III triial data, Moderna has also requested authorisation from various regulatory agencies around the world for its Covid-19 vaccine in adolescents.
At present, the company is conducting a Phase II/III trial, known as KidCOVE study, of the vaccine in children aged six months to below 12 years.