EU's drug regulator approves Pfizer vaccine for young children
Move comes amid a fourth wave of coronavirus in Europe.
The European Union's drug regulator on Thursday approved the use of the Pfizer-BioNTech coronavirus vaccine for children ages 5 to 11, as Europe grapples with a resurgence of COVID cases.
The European Medicines Agency recommendation will now be sent to the European Commission for final approval. Health authorities for each country in the bloc will then decide if and when to begin inoculating children.
While children remain at low risk of severe COVID-19 disease and death compared with the adult population, they can still transmit the disease to others. Children now account for the majority of cases in Germany and the Netherlands, and authorities say vaccination is critical to stemming the spread.
The COVID-19 vaccines are highly effective at preventing hospitalization and deaths, and the US Federal Drug Administration has found that the vaccine formula for 5- to 11-year-olds, called Comirnaty, has an efficacy rate of 90.7%.
"The benefits of Comirnaty in children aged 5 to 11 outweigh the risks, particularly in those with conditions that increase the risk of severe COVID-19," the EMA said in a statement.
The approval comes as Europe faces a fourth wave of the pandemic. More than 100,000 people have died in Germany since the start of the pandemic as a result of COVID-19, a public health agency said Thursday. Neighboring Austria, which last week became the first European country to make COVID vaccination a legal requirement, returned to a full national lockdown on Monday, while the Netherlands has imposed athree-week partial lockdown.