The European Union’s drug regulator on Thursday recommended expanding the use of Pfizer-BioNTech’s COVID-19 vaccine for children from 5 to 11 years old.
The decision, announced by the European Medicines Agency (EMA), cited Pfizer’s clinical trial data, which the company says indicates a 90.7 percent efficacy in preventing illness in the age group.
“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 COVID-19 vaccine developed by Pfizer and its German partner BioNTech called Comirnaty is already approved by EMA for use in adults and children aged 12 and above.
EMA recommending the Pfizer jab for young children marks the first time the EU regulator has cleared a COVID-19 shot for use in this age group. While final approval is up to the European Commission and is not confirmed yet, it typically follows EMA recommendations.
In children from 5 to 11 years old, a dose of the two-shot regimen is one-third lower than that used in people aged 12 and above. Just like in the older age groups, it is administered as two injections in the muscles of the upper arm three weeks apart.
The EU joins a growing number of countries, including the United States, Canada, Israel, China, and Saudi Arabia, which have cleared COVID-19 vaccines for children in the 5–11 year age group and younger.
Earlier this month, the U.S. Centers for Disease Control and Prevention (CDC) recommended that practically every child in the United States between 5 and 11 get Pfizer’s COVID-19 vaccine.
The only exceptions to the recommendation are children with a history of severe allergic reactions to a previous vaccine dose or a component of the vaccine, or a known allergy to a component of the shot. At least 10 percent of the 28 million eligible American children have had the first dose.
Some experts, though, have said that most children don’t need the shot because they’re at little risk of severe disease when they contract the CCP (Chinese Communist Party) virus. Federal officials disagree, pointing to the small number of hospitalizations and deaths among the age group and asserting the benefits of vaccination outweigh the risks.
“While children remain more resilient than adults to this virus, they still remain at risk. And with the help of vaccines, we can prevent COVID-19 and many other diseases that were once fatal,” CDC Director Rochelle Walensky told reporters.
EMA clearing the shot for young children also comes as the World Health Organization said on Wednesday that as children and adolescents are at a lower risk from the CCP virus, countries should prioritize adults and sharing doses with the COVAX program aimed at supplying the world’s poorest countries which have struggled to get vaccines.
Other countries previously announced they have decided to limit the use of COVID-19 shots based on the so-called mRNA technology to younger people after reports of possible cardiovascular side-effects.
Some U.S. advisers have also cautioned against vaccinating every child, noting that heart inflammation post-vaccination is much higher among youth than adults, particularly among young males, and that children who have recovered from the CCP virus may not need a shot.
“It’s safe to assume that vaccinating a healthy child would take this extremely low risk of serious disease and drive it down even lower,” Drs. Nicole Saphier and Marty Makary wrote in an op-ed this week.
“There’s an important exception, though: If a child already had COVID, there’s no scientific basis for vaccination,” they added, pointing out how none of the previously infected, including those who didn’t get a jab in the Pfizer trial contracted the illness.
The CDC has recommended that people with post-infection immunity, widely known as natural immunity, should still boost their protection against the CCP virus with a vaccine.
Zachary Stieber and Reuters contributed to this report.
