The European Medicines Agency (EMA) on Thursday recommended the Pfizer-BioNTech COVID-19 vaccine for children between the ages of 5 and 11 years old, opening the way for European Union countries to approve the shots for children.
The European Union health regulator said its human medicines committee's decision was based off data from a study that found that the COVID-19 vaccine was roughly 91 percent effective at preventing symptomatic COVID-19 in children within that age group.
Study data found that three children out of 1,305 who received Pfizer's Comirnaty vaccine developed the virus compared to 16 children from the 663 who were given a dummy injection.
The EMA said that the committee "concluded that 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."
A final decision now rests with the European Commission, which will consider the EMA committee's recommendation.
"If the EC grants the variation regarding a vaccination in this age group, the decision will be immediately applicable to all 27 EU member states," Pfizer said in a statement following news of the EMA committee's positive recommendation.
"If approved, COMIRNATY will be the first COVID-19 vaccine authorized in the European Union for individuals 5 to under 12 years of age," it added.
The news comes after federal health agencies in the United States signed off in early November on the use of the Pfizer vaccine for children as young as 5 years old.
The announcement came as welcome news to parents and health officials eager to see a higher portion of the American population vaccinated, especially in time for the busy holiday season.
However, the United States is still contending with a slight upward trajectory in COVID-19 cases.
On Tuesday, the U.S. saw over 100,000 COVID-19 cases and over 159,000 the day prior, according to data from the Centers for Disease Control and Prevention. A month prior on Oct. 23, the U.S. saw over 29,000 cases.
Europe, meanwhile, is seen as the global center of the latest wave in cases, attributed to the highly contagious delta variant, low vaccination rates in some countries, and relaxed precautions to prevent the virus' spread.