Germany’s vaccine advisory committee on Thursday recommended that Pfizer-BioNTech’s COVID-19 vaccine should only be given to adolescents with pre-existing conditions that raise their risk of getting seriously sick if they get the pulmonary illness.
The advisory committee, called STIKO, said in a statement that it was not currently recommending the COVID-19 vaccine be given to those aged 12–17 without pre-existing conditions, even though the European health regulator in May approved the Pfizer-BioNTech shot for use in children as young as 12 under a conditional marketing authorization.
STIKO said that, despite its recommendation, doctors may still administer the vaccine to adolescents if the recipients accept the risk.
Ruediger von Kriess, a paediatrics professor and STIKO committee member, said previously it might be preferable to endorse the vaccine for use in children only if they have pre-existing conditions that elevate their risk of serious complications if they contract COVID-19, citing the lack of data on the vaccine’s long-term effects.
The European Medicines Agency approved Pfizer-BioNTech’s COVID-19 vaccine, called Comirnaty, for emergency use on the basis of a trial involving around 44,000 people aged 16 and over, which was later extended to include 2,260 children aged 12 to 15.
“Of the 1,005 children receiving the vaccine, none developed COVID-19 compared to 16 children out of the 978 who received the dummy injection,” the agency said in a statement. “This means that, in this study, the vaccine was 100 percent effective at preventing COVID-19 (although the true rate could be between 75 percent and 100 percent),” it added.
Besides noting common side effects like fever, chills, and muscle and joint aches, the agency said some allergic reactions have occurred with the vaccine, including a very small number of cases of severe allergic reactions.
Pfizer-BioNTech said that a pediatric study evaluating the safety and efficacy of the COVID-19 vaccine in children 6 months to 11 years of age is currently ongoing. The companies expect to have data ready to submit to European authorities in September for two groups—children 2–5 years of age and 5–11 years of age.
Comirnaty was the first COVID-19 vaccine to receive authorization in the European Union and is the first to have its conditional marketing authorization extended to adolescents.
Reuters contributed to this report.