AMSTERDAM -- The European Union's drug regulator said Wednesday that it has started evaluating whether to authorize Moderna’s COVID-19 vaccine for children ages 5 to 11, a decision that could significantly open up COVID-19 vaccination across the continent for young children.
The Amsterdam-based European Medicines Agency already is evaluating the vaccine made by Pfizer-BioNTech for use in the 5-11 age group. In a statement on Wednesday, the EMA said it anticipates making a recommendation about Moderna's vaccine in about two months, unless more data or analysis are needed.
The EMA's announcement comes as coronavirus infection levels are rising across much of Europe. It is the only World Health Organization region where COVID-19 has steadily increased for the past six weeks; the number of cases recorded in WHO's 61-country Europe region accounted for about two-thirds of the 3 million new infections reported globally in the past week.
Moderna said last month that a low dose of its COVID-19 vaccine is safe and appears to work in 6 to 11 year olds. Its vaccine is still pending authorization for use in people under 18 in the U.S.
Earlier this month, the U.S. began rolling out coronavirus vaccines for young children after authorities cleared lower doses of the Pfizer-BioNTech shot for kids ages 5 to 11.