Rockland-based Pfizer plans to submit COVID vaccine for FDA approval for kids 5 to 11
Rockland-based Pfizer says its vaccine is safe and effective in children as young as 5 years old.
Company officials announced trial results in more than 2,000 kids ages 5 to 11 showed it is safe, well-tolerated and triggers a strong antibody response.
Dr. Christina Johns is the senior medical advisor for PM Pediatrics, the nation’s largest pediatric urgent care with over 70 offices in 15 states.
She says, “I'm encouraged when they report it is safe and effective and tolerated, which means likely the side effect profile is mild, like we've seen in the older age group— the 12 to 16 group.”
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The news comes as pediatric COVID-19 cases have skyrocketed by 240% since July.
“We are seeing that as more children get infected overall, more children are getting severe disease,” Dr. Johns says.
Pfizer’s CEO said on Twitter, “Considering the rise in pediatric cases of COVID-19 and the substantial threat the delta variant poses to children, we are glad to share this news with the world."
Because the antibody response in that age group matches the response seen in children ages 16 and up, Pfizer plans to submit the vaccine to the Food and Drug Administration by the end of this month.
Dr. Johns says this step is very important in keeping kids safe in schools and preventing severe infections.
Pfizer’s results on the COVID-19 vaccine for kids under 5 years old is expected later this year.