(CN) — Pfizer released a study Friday showing that its vaccine prevented symptomatic Covid-19 in 90.7% of children ages 5 to 11 in a clinical trial.
The report, submitted by Pfizer and its partner BioNTech, is under review by the Food and Drug Administration. If the FDA grants authorization, the Centers for Disease Control and Prevention will be tasked with setting the policy of the vaccine roll-out.
More than 2,200 children received a smaller dose of the Pfizer-BioNTech vaccine during the clinical trial. The kid-size dose is one-third of the adult dose. The number of trial participants who received the vaccine was double the number who received a placebo. Among the children who received the placebo, 16 got Covid-19. Three of the vaccinated participants got Covid-19.
According to the report, the clinical trial found that participants experienced mild side effects from the shot and the vaccine was largely safe.
Pfizer and BioNTech pointed to the study as an encouraging sign in the fight against the pandemic, contending in the report that authorization would help reduce the spread of the virus and protect children from severe illness and death. Covid-19 cases and hospitalizations among children have increased in recent months, particularly in areas with lower vaccination rates.
If the FDA and CDC approve the vaccine for those aged 5 to 11, approximately 28 million kids will become eligible for a jab. The White House this week unveiled plans to distribute enough doses to pediatricians, pharmacies and schools to vaccinate all eligible children. The Biden administration said it plans to ship 15 million doses to providers nationwide within a week of the shots for kids being granted approval.
“During the prior administration the vaccine became approved for emergency use by the FDA and CDC, and then the system wasn't ready to actually put shots in arms,” said White House Covid-19 coordinator Jeff Zients during a press conference Wednesday. “So we're going to be ready, pending the FDA and CDC decision that'll be based on science.”
Beyond limiting the spread of Covid-19, Pfizer and BioNTech asserted in their findings that administering the vaccine to children could be crucial to keeping kids in the classroom and getting caregivers back to work.
“Vaccination will help restore the availability of in-person learning for children by limiting community spread and school outbreaks and reducing the need for student quarantine,” the report reads. “In-person learning is critical for childhood development, adequate learning and broader economic impact on the society due to the burden imposed on working parents/caregivers by school closures and quarantines and the impact that loss of education has on children’s future economic security.”
The Pfizer-BioNTech report further highlights the social and emotional health of young children as factors that could be affected by the distribution of vaccines to kids.
“Mental health and wellbeing in children have been significantly impacted by the ongoing pandemic and rounds of school closures, associated with increased screen time and social media use, reduction in physical activity and more sedentary behavior, unhealthy dietary habits and overall increased psychological distress in school age children,” the report says.
The data on Covid-19 immunizations for children comes on the heels of FDA approval for a mix-and-match approach to booster shots.
Further, six months after their last dose, adults age 65 and older and those at higher risk of infection due to their jobs or chronic health conditions can get a booster shot. Vaccines from Pfizer-BioNTech, Moderna and Johnson & Johnson are all approved by the FDA for boosters.
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