Freddy Caldera, DO, MS
Francis A. Farraye, MD, MSc, MACG
May 18, 2021
On May 12, the CDC’s Advisory Committee on Immunization Practice recommended the use of Pfizer-BoNTech vaccine in adolescents 12 and older after the Food and Drug Administration (FDA) extended emergency use authorization down to age 12.
The Pfizer and BioNTech study had approximately 2,000 adolescents ages 12-15 with about half randomized to receive the vaccine and half to receive a placebo. Vaccine efficacy, seven days after the second dose, for this age group was 100%. Among just over 1,000 vaccine recipients, there were no cases of COVID-19, while 16 were reported among more than 970 placebo recipients.
The vaccine will be given to adolescents in two doses 21 days apart, the same as for adults. The need for consent from a parent or guardian will depend on state or local laws.
The most common side effects in adolescents were pain at the injection site, fatigue, headache, chills, muscle pain, fever, and joint pain, consistent with trials in older teens and adults.
About 6% of vaccine recipients experienced an adverse event, including seven cases of swollen lymph nodes. There were five serious adverse events in the vaccine group (0.4%) including one person with abdominal pain, constipation and neuralgia and others with depression, anxiety and suicidal ideation. None of the serious events were determined to be related to the vaccine and no deaths were reported. There also were no reports of blood clots, serious allergic reactions, or Bell’s palsy.
This notice was reviewed by the ACG Committee on Pediatric Gastroenterology
CDC May 12, 2021: https://www.cdc.gov/media/releases/2021/s0512-advisory-committee-signing.html
FDA May 10, 2021: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use