USFDA approves Pfizer for use in 12-15 years old

The United States’ drug regulator on Monday expanded the emergency authorisation given to the Pfizer Covid vaccine for use in children as young as 12.

This is the first vaccine to be authorised by the Food and Drug Administration for use in this age group in the United States. Until now, the vaccine was being administered to people aged 16 and above.

President Joe Biden called it a “promising development” in the fight against the virus, which has affected over 3.27 crore and killed 5.82 lakh in the country, reported AFP.

“Having a vaccine authorised for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic,” said Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research.

The Pfizer vaccine will be administered as a series of two doses, three weeks apart, the same dosage and dosing regimen for 16 years of age and older.

However, the vaccine will not be available for use in children immediately. An advisory committee of the Centers for Disease Control and Prevention will meet first to review the data and make recommendations for the vaccine’s use in the 12-15 age group, according to The New York Times.

Pfizer’s clinical trials have shown that these children may safely receive the dose already available for adults. The company had enrolled 2,260 participants ages 12 through 15 years and gave them either two doses of the vaccine or a placebo three weeks apart.