In the crucial study with five to eleven year olds, the vaccine was well tolerated and generated a strong immune response, both companies announced on Monday. The data are now to be submitted to the European Medicines Agency (EMA), the US FDA and other regulatory authorities around the world.
These are the first results from a pivotal study for a Covid-19 vaccine for children under the age of twelve. In the study, Biontech and Pfizer tested a dosage of their already approved vaccine of ten micrograms. Two doses were given 21 days apart. The vaccination for over twelve years old provides a dose of 30 micrograms. The immune response in children at the lower dose was comparable to that observed in a previous study with 16 to 25 year olds – as were the side effects. 2,268 children between the ages of five and eleven took part in the study.
“Since July, Covid-19 cases among children in the United States have risen by around 240 percent. This underscores the need for vaccinations,” said Pfizer CEO Albert Bourla. The study results are a strong basis for applying for approval of the vaccine in children aged five to eleven. “Our plan is to submit them to the FDA and other regulatory agencies as soon as possible.”
BioNTech and Pfizer plan to publish data on the use of the vaccine in children between the ages of six months and five years in the fourth quarter of this year. For children and adolescents aged twelve and over, the vaccine was approved in the US and the EU in May.
Jane Stock is a technology author, who has written for 24 Hours World. She writes about the latest in technology news and trends, and is always on the lookout for new and innovative ways to improve his audience’s experience.
