The Pfizer/BioNTech coronavirus shot was given the go-ahead on Thursday for children ages five to 11 in Europe, paving the way for vaccination in a cohort where the virus is spreading rapidly.
The European Medicines Agency (EMA) said a panel of experts “recommended allowing an extension of the indication for the Covid-19 vaccine Comirnaty to use in children aged five to 11”, using the brand name of the injection.
The vaccine is already approved for use in people aged 12 years and older in the EU’s 27 countries.
The Pfizer shot has so far only been approved in a small number of countries for children ages five to 11, including the United States, Israel and Canada.
Children aged five to 11 receive a third of the dose that older people receive, with two injections, three weeks apart, the EMA said.
The vaccine was 90.7 percent effective in a study of nearly 2,000 children of that age, it added. Side effects were usually “mild or moderate” for several days and included injection site pain, fatigue, headache, muscle aches, and chills.
The EMA therefore “concluded that the benefits of Comirnaty in children aged five to 11 outweigh its risks, especially in those with conditions that increase the risk of severe Covid-19.”
In the Netherlands, where the EMA is based, authorities said earlier this week that the largest increase in cases was among children under 12 years of age.
The regulator has so far approved four vaccines for use in the EU: Pfizer and Moderna, which use messenger RNA technology, and AstraZeneca and Johnson & Johnson, which use viral vector technology.
(This story was not edited by NDTV staff and was generated automatically from a syndicated feed.)