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May 1, 2021

Pfizer and BioNTech have asked the European Medicines Agency to extend the use of its Covid-19 vaccine to cover adolescents aged 12 to 15 after trial data showed it worked well and was safe in this group, the companies announced Friday, marking a significant step in expanding access to the shot where most available products are only licensed for use in adults. 

Preliminary data from a clinical trial involving over 2,000 participants, which was published in March, indicated the vaccine to be 100% effective at preventing illness in children aged 12 to 15, higher than the already impressive 95% efficacy rate reported in adults.  

The companies said the vaccinated teens tolerated the shot well and displayed “robust antibody responses,” showing side effects consistent with those aged 16 to 25.

The companies have already asked the U.S. Food and Drug Administration to extend the vaccine’s license in the U.S. and said they plan to request further amendments with regulators worldwide.   

A vaccine for children would help make for a smoother and safer return to in-person schooling come fall, as well as cutting the risks of illness and transmission from children. Several manufacturers are trialing shots in younger people. Moderna, for example, has several ongoing trials exploring its vaccine’s effectiveness in young children and adolescents and Pfizer is testing one for use in children between the ages of six months and 11 years. Oxford University put its trials in children on hold, which used the shot it developed with AstraZeneca, over fears of rare blood clots. 

Parents aren’t necessarily eager to have their children, who are at a much lower risk from Covid-19, vaccinated in the first wave of childhood shots. One poll indicated only half of Americans planned on getting their children immunized as soon as vaccines become available.