Pfizer-BioNTech announcement on vaccine efficacy in kids ages 12+ and why it matters

You might be tempted to scroll past another headline about COVID-19 vaccine efficacy, but a pediatric infectious disease specialist with The University of Texas Health Science Center at Houston (UTHealth) said you don’t want to miss Pfizer-BioNTech’s latest announcement.

Pfizer-BioNTech released preliminary results today from a company-sponsored study showing vaccination is not only safe and effective in adolescents ages 12-15, but it also leads to a higher protective antibody response than in participants ages 16 to 25. The study of 2,260 participants also found the vaccine to be 100% effective against symptomatic disease.

Teenagers ages 16 and up are currently able to receive Pfizer’s vaccine under emergency use authorization from the U.S. Food and Drug Administration (FDA).

“We know that teenagers can be drivers of virus spread just like adults,” said Michael Chang, MD, assistant professor of pediatrics with McGovern Medical School at UTHealth and infectious diseases pediatrician with UT Physicians. “This news, paired with the latest data from the U.S. Centers for Disease Control and Prevention showing that COVID-19 vaccines are effective against asymptomatic infection, paints a very promising picture that we’ll soon be able to vaccinate all teenagers, closing one of the largest remaining gaps in coverage against the virus.”

Pfizer’s CEO said the company plans to submit their data to the FDA for emergency use authorization to be granted for their vaccine’s use in children ages 12 to 15, with the hope of receiving approval before the start of the next school year.

Chang said the timeline for authorization will depend on how much safety data, which is the information researchers gather from participants post-vaccination, the FDA will require.

“This study just finished recruiting patients at the end of January, so they likely only have about 6 weeks of safety data. For adult studies, safety data was collected for 60 to 90 days, but for children it’s possible the FDA may want to wait longer. No one knows for sure how much data the CDC or FDA will require,” Chang said.

If Pfizer’s vaccine is authorized for use by the time school starts, Chang said it could reduce transmission from children to adults.

“We already know in-person schooling is already pretty safe when mask wearing and physical distancing guidelines are followed, but being able to vaccinate middle and high school students would make it even safer. A remaining concern has been sports teams and extracurricular activities, but theoretically, if most or all of the students are vaccinated, then those activities become much safer and the risk of children bringing COVID-19 home is way lower,” Chang said.

Chang noted while it’s important that children younger than 12 receive the vaccine, data shows they aren’t key drivers of spread like teenagers and adults. Pfizer is studying the vaccine’s safety in children 6 months to 11 years old.

Moderna has a clinical trial assessing its mRNA COVID-19 in participants ages 12 to 17. They’ve also announced plans to study vaccine safety in children 6 months to 12 years. AstraZeneca started recruiting participants ages 6 to 17 years old in the United Kingdom in February, and Johnson & Johnson has announced they intend to conduct clinical trials for adolescents and children as young as newborns soon after.  

For more information on COVID-19 vaccines, visit the CDC’s website.

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