Pfizer Inc. and BioNTech SE gained US emergency use authorization for their COVID vaccine booster shot for kids ages 5 to 11, a move to bolster protection in school-aged kids as contagious omicron subvariants spread across the country.
The Food and Drug Administration clearance allows the use of the booster at least five months after children receive the second of their first two shots. The companies submitted data to the agency in late April showing the third shot could bolster antibodies in the age group.
Side effects of the booster shot in kids included pain, redness and swelling at the injection site, the FDA said in a statement.
The booster “is effective in helping to prevent the most severe consequences of COVID-19 in individuals 5 years of age and older,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
No COVID vaccine has yet been authorized for kids under 5. The FDA has held several dates in June for its advisers to discuss data from Pfizer and its rival Moderna Inc. on COVID vaccines for the youngest kids.
