Pfizer says vaccine is around 90% effective in kids aged 5 to 11 years
Pfizer and BioNTech reported that their COVID-19 vaccine is around 90% effective against symptomatic illness in children aged 5 to 11 years with no serious safety concerns, according to a document published Friday by the FDA.
The document was posted online ahead of Tuesday’s meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) , which will review and vote on the companies’ request for an emergency use authorization for the vaccine in the young age group.
Last month, the companies reported initial data showing that the two-dose vaccine was safe and generated “robust” neutralizing antibody titers in a phase 2/3 study before submitting topline data to the FDA.
The White House has already announced plans for a nationwide campaign to roll out and promote the vaccine for kids aged 5 to 11 years, pending authorization.
The proposed regimen for children aged 5 to 11 years is two shots given 21 days apart — the same as in older age groups. However, they would receive smaller doses — two 10 µg shots.
In the newly published document, which includes results from a study of around 2,250 children randomly assigned in a 2:1 ratio to receive the vaccine or placebo, the vaccine’s efficacy against laboratory-confirmed symptomatic COVID-19 occurring at least 7 days after a second dose in children without evidence of a prior SARS-CoV-2 infection was 90.7% (two-sided 95% CI, 67.7%-98.3%), with no reported cases of severe COVID-19 or multisystem inflammatory syndrome in children.
There were three recorded cases of COVID-19 in the vaccine arm of the trial compared, with 16 in the placebo arm. The document notes that the earliest confirmed case of COVID-19 in the study occurred in July, and most cases occurred in August and September — encompassing a time when delta was the predominant SARS-CoV-2 variant circulating in the U.S. and globally.
“These data show that the two-dose primary series of BNT162b2 10 µg given to children 5 to [younger than] 12 years of age confers a high degree of protective efficacy against COVID-19 during a period when the delta variant of concern predominates in the U.S.,” the document says.
The Pfizer-BioNTech vaccine, branded as Comirnaty, was fully approved by the FDA in September for people aged 16 years or older. It has been available under an EUA for children aged 12 to 15 years since May.
If the VRBPAC votes to recommend the vaccine in children aged 5 to 11 years and the FDA issues an EUA, the CDC’s Advisory Committee on Immunization Practices would meet to make federal recommendations for this age group.
Pfizer and Biotech said earlier this month that topline study data for two younger groups — children aged 2 to 4 years and children as young as age 6 months — “are expected as soon as the fourth quarter of this year.”