Pfizer plans to seek approval for the Covid vaccine for the youngest after a test in the US found it safe for teens ages 12 to 15.
The U.S. pharmaceutical company, which partnered with German firm BioNTech to produce the vaccine, said it would submit the test data to the U.S. Food and Drug Administration (FDA) in the coming weeks and other regulators thereafter.
In a statement, Albert Bourla, Pfizer chairman and chief executive, said the approval would pave the way for vaccinations to begin in the young age group before next school year. The vaccine is approved for use in people aged 16 and over.
Researchers in the US examined the use of the Pfizer / BioNTech vaccine in a trial of 2,260 children aged 12 to 15 years. Half were given the vaccine and the other half received placebo. The researchers recorded 18 cases of Covid among 1,129 people in the placebo group and 0 cases among 1,131 people who received the vaccine.
Shën.red. Placebo - a substance or treatment designed to have no therapeutic value.
According to Pfizer, the vaccine was well tolerated, with side effects similar to those seen in the 16-25 age group. The statement did not detail the side effects for the younger group, but in adult testing the side effects were generally mild to moderate and included injection site pain, headache, fever, and fatigue.
In the middle of this month, the company Moderna also tested the vaccine on children and it turned out to be safe.
Sources: Guardian, Euronews
