Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) have announced that their COVID-19 vaccine was 90.7% effective at protecting against symptomatic COVID-19 in children ages 5 to 11.
The study concluded that a 10-µg dose of the BNT162b2 vaccine, which is one-third the amount authorized for people 12 and older, had the best benefit-risk profile.
Recipients of 20- and 30-µg doses had significantly higher rates of mild or moderate side effects, including fatigue, headache, chills and muscle pain.
The independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet next week to discuss the prospect of recommending the vaccine for use in 5- to 11-year-olds to the FDA.
The BNT162b2 vaccine is currently FDA approved for people 16 and older. An emergency use authorization currently covers children aged 12 to 15.
One concern regarding the use of the vaccine in younger children is its association with myocarditis and pericarditis in a small number of recipients. Myocarditis is inflammation involving heart muscle, while pericarditis involves inflammation of heart lining. The VRBPAC meeting session will include a presentation on the risk of myocarditis in adolescents and young adults from Dr. Mathew Oster, a pediatric cardiologist at Children’s Healthcare in Atlanta.
Pfizer reported no cases of myocarditis or pericarditis approximately three months after administering the second dose in the children between the ages of 5 and 11.
The study found no new safety signals linked to the drug and reported that adverse events were in line with other trials.
The number of children infected with COVID-19 skyrocketed with the spread of the Delta variant, jumping 419% in August and September compared with the prior two months, according to a Pfizer briefing document shared with FDA.