On 10 May 2021, the U.S. Food and Drug Administration extended the emergency use authorization (EUA) for Pfizer-BioNTech COVID-19 vaccine for the prevention of COVID-19 to adolescents aged 12 to 15 years. More recently, the European Medicines Agency has mirrored this recommendation.
Safety and efficacy data available to support EUA in adolescents from 12 years of age include 2260 participants aged 12 to 15 years enrolled in a randomized placebo-controlled clinical trial in the United States[^1]. Of these, 1131 adolescent participants received the vaccine and 1129 received a saline placebo. More than half of the participants were followed for safety for at least two months after the second dose.
The most frequently reported side effects in adolescent clinical trial participants, which generally lasted 1 to 3 days, were injection-site pain, tiredness, headache, chills, muscle pain, fever, and joint pain. With the exception of injection site pain, more adolescents reported these side effects after the second dose than after the first dose. Also, the observed vaccine efficacy was 100% (95% confidence interval, 75.3 to 100).
Having obtained the approval for the vaccine to be used in this age group from 12 to 15 years does not mean a change in the priority groups for vaccination. The priority groups for vaccination according to WHO are those who are most at risk of developing severe disease, including older adults, people with co-morbidities and health workers who are at high risk of contracting the disease and potentially spreading the virus to their patients. The BNT162b2 should be used in adolescents age 12-15 years with comorbidities that put them at significantly higher risk of serious COVID-19 disease, alongside other high-risk groups.
We need to keep in mind that we need a global effort to solve this pandemic and that the priority target groups for vaccination are the same across the world.
WHO, the FDA and EMA have approved use of Pfizer-BioNTech COVID-19 vaccine for adolescents aged 12-15.
Prioritization of groups at high risk of contracting or suffering serious illness from COVID-19 should not change.
- Frenck RW Jr et al. Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents. N Engl J Med. 2021 May 27. doi: 10.1056/NEJMoa2107456. Epub ahead of print. PMID: 34043894.