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 earlier Friday.
According to Sharma, Canadian officials were watching the U.S. process carefully, and any such deliberations and discussions from south of the border would be “inputs” into their review as well.
“Our scientists are in the process of looking at not only the results from the clinical trials and the studies that were done, but also the details on the new formulation,” she said.
Despite the federal drug agency’s emergency approval, one more regulatory hurdle remains for the vaccine to go into full circulation in the U.S.
The Centers for Disease Control and Prevention (CDC) are set to release more detailed recommendations on Tuesday on which kids could get the vaccine — with a final approval from the agency’s director coming shortly after.
“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.
The pediatric version of Pfizer’s COVID-19 vaccine differs slightly from the original, adult formula — with U.S. states getting ready to roll out 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.
Should the new formula get approved, Canada is expected to receive 2.9 million doses — enough for every child to get their first shot.
Several countries have already begun inoculating children under the age of 12 while China has just begun issuing vaccinations for kids as young as three.
Despite children being at lower risk of severe illness or death from COVID-19 in comparison to older people, U.S. data revealed that five-to-11-year-olds have still been seriously affected after contracting the disease.
As many as 8,300 have been hospitalized so far in the U.S. with a third of that requiring intensive care. Over 145 deaths have been reported in that age group so far, according to the FDA.
—with files from The Associated Press and The Canadian Press