Moderna says Covid vaccines are safe for children; Requests EMA approval
Moderna says its Covid-19 vaccine is safe to use in children aged 6 to 11. The manufacturer requested approval from Europe's regulator, the European Medicines Agency (EMA) in Amsterdam. It expects to decide in two months.
The supervisor must assess the results of trials and decide whether the drug can indeed be used on everyone aged six years and older. For this, conditional market authorization for the vaccine would have to be amended. The Moderna vaccine, called Spkevax, has already been approved for everyone aged 12 and older.
Previously, Pfizer and BioNTech applied for approval of their coronavirus vaccine for children aged 5 to 11 years. The EMA will likely issue its decision on that application in December.
The EMA's conclusions go to the European Commission. It ultimately decides whether the vaccine may be used for children. After that, it is up to the Netherlands and other EU countries to determine if they will actually vaccinate young children.
Reporting by ANP.