The United States on Monday authorised the Pfizer-BioNTech Covid-19 vaccine for children aged 12 to 15 years old, a move aimed at bringing kids back to school. The decision is likely to pave the way for other countries to follow suit in what would be a big step towards the restoration of normalcy as the world fights the deadly pandemic.
The US Food and Drug Administration (USFDA) had earlier granted an emergency use authorisation for the Pfizer vaccine for individuals aged 16 and older.
"This is a promising development in our fight against the virus," said President Joe Biden.
The head of the European Medicines Agency said Monday that BioNTech/Pfizer's jab against Covid-19 soon could be approved for 12- to 15-year-olds in the EU, as well, perhaps as early as this month.
The USFDA declared the Pfizer vaccine is safe and offers strong protection for younger teens based on testing of more than 2,000 U.S. volunteers ages 12 to 15. The study found no cases of COVID-19 among fully vaccinated adolescents compared to 18 among children given dummy shots.
Researchers found the kids developed higher levels of coronavirus-fighting antibodies than earlier studies measured in young adults.
The younger teens received the same vaccine dosage as adults and had the same side effects, mostly sore arms and flu-like fever, chills or aches that signal a revved-up immune system, especially after the second dose.
Pfizer’s testing in adolescents “met our rigorous standards,” said FDA vaccine chief Dr. Peter Marks. “Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic.”
Pfizer and its German partner BioNTech recently requested similar authorization in the European Union, with other countries to follow.
The Covid-19 pandemic is still surging in many countries and has already claimed over 3 million lives worldwide.