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Pfizer and BioNTech's COVID-19 Vaccine Produces 100% Protection in Kids

By Brian Orelli, PhD - Mar 31, 2021 at 1:48PM

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The companies plan to apply for emergency use authorization in adolescents in the coming weeks.

Pfizer (PFE -0.23%) and BioNTech's (BNTX 5.63%) COVID-19 vaccine, BNT162b2, produced 100% efficacy in adolescents 12 to 15 years of age, according to data from a phase 3 clinical trail released on Wednesday.

While impressive, and better than the roughly 95% efficacy that the vaccine produced in adults, the 100% efficacy is based on just 18 COVID-19 cases in the placebo group vs. 0 in the vaccine group. If the study had enrolled more kids or gone on longer, there might have been a case in the group of patients who received the vaccine, ruining BNT162b2's perfect efficacy.

Nevertheless, by other measures, the vaccine does appear to be working better in adolescents than older participants. Antibody levels created by the vaccine in adolescents were around 75% higher than the antibody levels seen in participants ages 16 to 25 who were in earlier clinical trials.

Doctor showing a child a hypodermic needle.

Image source: Getty Images.

The companies plan to apply to the Food and Drug Administration for emergency use authorization to treat adolescents in the coming weeks. Pfizer's Chairman and CEO Albert Bourla noted the goal is to gain authorization early enough that adolescents could be vaccinated before the start of the next school year.

Pfizer and BioNTech are also testing the vaccine in children 6 months to 11 years old. The companies are breaking the large group of children of varying sizes into three groups. The 5 to 11 year-old group started receiving the vaccine last week, and the 2 to 5 year-old participants are scheduled to start getting the vaccine next week. The youngest group from 6 months to 2 years old will come later. The clinical trial in younger children will take longer than the study in adolescents because the companies have to figure out the optimal dose for younger children, who are much smaller than adults.

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