American drugmaker Pfizer and its German partner BioNTech have reported that its COVID-19 vaccine was 100 percent safe and effective while creating strong antibody responses in kids aged between 12 to 15 years.
The vaccine is already authorized in the US for those aged 16 and above. Pfizer and BioNTech have now planned to submit the data to regulators in the US and Europe as soon as possible, seeking to amend their vaccine authorizations to include the younger age group.
The American drugmaker hopes that vaccinations of those between 12 to 15 years old could begin before the next school year, Mr. Albert Bourla, Pfizer’s chairman and chief executive stated.
In a study that included 2,260 adolescents aged between 12 to 15, there were 18 cases of COVID-19 in the group that got a placebo shot and none in the group that got the vaccine, resulting in 100 percent efficacy in preventing COVID-19, the companies stated.
The vaccine was well tolerated, with side effects in line with that seen among those aged 16 to 25 in the adult trial. It did not show the side effects for the younger group, but the adult trial’s side effects generally were mild to moderate such as injection-site pain, headaches, fever and fatigue.
Mr. Bourla stated that the company planned to seek emergency authorization from the US Food and Drug Administration in the coming weeks and to other regulators across the globe, with the hope of starting to vaccinate teens aged between 12 to 15 before the start of the next school year.
Last week, the companies gave the first vaccine doses in a series of trials testing the vaccine in younger children, that will eventually go to those as young as 6 months of age.
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