The Daily Reformer
INDIANAPOLIS — On Wednesday, Pfizer announced that its COVID-19 vaccine is 100% effective in children as young as 12-years-old.
The phase three clinical trial enlisted 2,260 U.S. volunteers ages 12 to 15. Half of the children were given a placebo and half where given two doses of the Pfizer vaccine three weeks apart.
Preliminary data showed there were no cases of COVID-19 among fully vaccinated children compared to 18 positive cases among those given the placebo.
Dr. Ram Yeleti, Chief Physician at Community Health Network, said this a major step toward possibly beginning vaccinations in this age group.
“We should be able to start vaccinating children well before the fall school year and that’s I think the biggest thing top of mind for everyone” said Dr. Yeleti.
Pfizer’s vaccine is currently authorized for ages 16 and older, but Dr. Yeleti said vaccinating children of all ages will be critical to stopping the pandemic.
Still, Dr. Yeleti points out the work is far from over. He said Pfizer’s study is still small and the 100% efficacy rating could change if expanded.
The company said children had side effects similar to young adults. The main side effects are pain, fever, chills and fatigue, particularly after the second dose.
Pfizer researchers also reported higher levels of virus-fighting antibodies compared to other young adults.
“Antibodies we use as a marker to show how good the immune system is reacting to that vaccine,” said Dr. James Woods, a pediatric infectious disease specialist at Riley Children’s Hospital.
Dr. Woods said he was not surprised to see higher antibodies in younger populations, as kids typically have stronger immune system.
Pfizer and its German partner, BioNTech, plan to ask the U.S. Food and Drug Administration to allow emergency use of the shots starting at age 12 in the coming weeks.
“If all goes good and all goes as planned, we hope to have [vaccinations going] by this summer,” said Dr. Woods.
Dr. Woods said schools have already proven that they can lower the spread of the virus, thanks to masks and social distancing, but he said vaccinating students will be an added bonus.
“That’s just another layer of protection,” said Dr. Woods.
Pfizer’s study will continue to track participants for two years for more information about long-term protection and safety.
“We share the urgency to expand the use of our vaccine,” Pfizer CEO Albert Bourla said in a statement. He expressed “the hope of starting to vaccinate this age group before the start of the next school year” in the United States.
Pfizer isn’t the only company seeking to lower the age limit for its vaccine. Results also are expected soon from a U.S. study of Moderna’s vaccine in 12- to 17-year-olds.
The FDA has already allowed both companies to begin U.S. studies in children 11 and younger, working their way to as young as 6-months-old.