The US Food and Drug Administration (FDA) announced that the Pfizer-BioNTech mRNA vaccine, BNT162b2, is now cleared for emergency use in children aged 12 to 15. For the US, this is the latest step toward keeping case counts down and returning to normalcy.
In a statement, the FDA announced that it made this decision after carefully evaluating Pfizer and BioNTech’s Phase III Clinical trial data for the aged 12 to 15 cohort which was released on March 31. Out of the 2,260 adolescents involved, 18 placebo recipients contracted COVID-19, while none did in the vaccinated group. “BNT162b2 demonstrated 100% efficacy and robust antibody responses,” reads the Pfizer-BioNTech statement. The two companies plan to submit these results to be peer-reviewed for later publication.
“Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the FDA statement.
The Pfizer-BioNTech vaccine was already greenlit for emergency use in teens aged 16 and older back in December. The move to vaccinate even younger adolescents means a more optimistic outlook for middle and high schools trying to reopen in the fall.
Though adults are bearing the brunt of the pandemic, vaccinating children is still a critical move. From March 1, 2020, through April 30, 2021, approximately 1.5 million children aged 11 to 17 contracted COVID-19, according to the FDA statement. The data show that kids under 18 account for 12 percent of all COVID-19 cases, even if they make up only 0.1 percent of deaths.
Children younger than 12 will have to wait a little longer before they’re allowed to receive their jabs. Pfizer-BioNTech began its Phase I/II/III Clinical trial in children aged 6 months to 11 years in March. Those results are still forthcoming. But in a quarterly report presentation, Pfizer said it plans to apply for emergency authorization use for its vaccine in young children in September.
Johnson & Johnson and Moderna also have clinical trials in children underway. Moderna’s vaccine, which like Pfizer’s also uses mRNA technology, is currently being tested in adolescents aged 12 to 17 as well as young children aged 6 months to 11 years. Johnson & Johnson is currently conducting a Phase IIa trial in adolescents aged 12 to 17.
“[Vaccinating children] is a really important piece of coronavirus prevention,” Buddy Creech, a pediatric infectious disease expert at the Vanderbilt University Medical Center told NBC.“ When we vaccinate children, we don’t just protect them. We protect their parents and their grandparents.”