Pfizer COVID-19 vaccine authorized for children 5-11, U.S. FDA says

The FDA has given emergency authorization for the use of the Pfizer COVID-19 vaccine in children aged five to 11 years old, setting the stage for a mass vaccination campaign for young children across the United States.

The Pfizer pediatric vaccine is just one-third of the strength of the dosage given to adults and teens. It will be given as a two-dose series, with the doses three weeks apart.

The FDA’s authorization comes shortly after its expert panel unanimously recommended approval of the vaccine for this age group, saying the potential benefits outweighed any risks of side effects, including a rare heart complication known as myocarditis that has been reported in some teens and young adults who received a stronger dose.

Pfizer’s data found that the children’s vaccine had 91 per cent efficacy against symptomatic infection, with relatively few and minor side effects, like a sore arm. The vaccine was studied in approximately 3,100 children and no serious side effects were reported, the FDA said.

Health Canada is still examining whether to approve Pfizer’s application for its pediatric vaccine for Canadian children. A decision could still be “a few weeks away,” and likely won’t come until at least mid-to-late November, Health Canada’s Dr. Supriya Sharma said at a press conference Friday.

Even with this FDA approval, there is still one more step before vaccines are given to young children in the U.S. The Centers for Disease Control and Prevention (CDC) still needs to decide whether to recommend the vaccine and which children should receive it.

“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” acting FDA commissioner Dr. Janet Woodcock said in a press release Friday.

Health Canada is aware that the U.S. FDA has authorized Comirnaty (Pfizer-BioNTech's #CovidVaccine) for children aged 5-11. Health Canada’s review is ongoing and is being prioritized. #Covid19

— Health Canada and PHAC (@GovCanHealth) October 29, 2021

States are getting ready to roll out the vaccine that will come in special orange-capped vials to avoid dosage mix-ups with the full-strength adult version. More than 25,000 pediatricians and other primary care providers have signed up so far to offer vaccination, which will also be available at pharmacies and other locations.

—with files from The Associated Press

by Global News