AMSTERDAM - The Pfizer/BioNTech coronavirus vaccine is safe and effective for children from age 5, the European Medicines Agency (EMA) ruled. The experts noted that the vaccine's benefits, even for young children, outweigh the risk of side effects, which are usually mild. The EMA, therefore, advised the European Commission to approve the vaccine for administration to children aged 5 to 11 years.
The vaccine was already approved for children from 12 years of age and adults. In the Netherlands, Pfizer/BioNTech is the most commonly used coronavirus vaccine.
It has not yet been decided whether children under the age of 12 will also be eligible for a vaccination against the coronavirus in the Netherlands. The ball is now in the European Union's court. Until now, it has always followed the EMA's advice on coronavirus vaccines.
In the Netherlands, the Health Council is working on its own advice to the Cabinet on whether or not to vaccinate young children. It has been working on this advice for some time. A spokesperson for the Health Council could not say on Thursday when the advice would be ready.
Like adults, children will receive two injections in their arms, with three weeks between the first and second injection. An important difference is that children under 12 receive a lower dose: 10 micrograms instead of 30 micrograms. That produces a similar response from the immune system, according to the EMA's assessment committee.
"The immune system of children and adults basically works the same," explained chairman Ton de Boer of the Dutch medicine authority CBG. "The immune response of children is stronger than in adults, so a lower amount is enough for them."
In the vaccine study, 1,305 children under the age of 12 were given the vaccine. Three of them still contracted the virus in the following period. Of the 633 children in the control group who received a placebo, 16 became infected. The EMA, therefore, currently assumes an effectiveness of almost 91 percent. In practice, according to the EMA, this percentage can prove to be lower or even higher.
As with older people who received the injection, the younger children experienced side effects like pain or swelling around the injection site, fatigue, and headache. As with adults, medical authorities continue to "closely monitor" the safety of the vaccine.