On Monday, May 10, the FDA approved the Pfizer vaccine for COVID-19 for emergency use in adolescence 12-15 years of age. The FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria to amend the EUA, and that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks, supporting the vaccine’s use in this population. ¹
Yvonne Maldonado, MD, chair of the American Academy of Pediatrics Committee on Infectious Diseases and Chief of Pediatric Infectious Diseases at the Stanford University School of Medicine stated, “There are millions of infected children, thousands of hospitalizations, and over 260 deaths in children.”² Any death is tragic, but 260 out of millions of children infected and thousands hospitalized still has us wondering if the benefits outweigh the risks.
While there are some parents racing to see how soon they can get their growing teens vaccinated, others are asking some questions:
How long was the vaccine studied in this age group? How large was the study?
Pfizer Inc. completed enrolling children aged 12 to 15 in a COVID-19 vaccine study in January of this year, just 4 months ago, with 2,260 participants volunteered by their parents.³ Of those 2,260, about half (1,131) received the vaccine while the remaining 1,129 received the placebo.
What are the long-term effects of the vaccine?
That has yet to be determined. All participants in the trial will continue to be monitored for long-term protection and safety for an additional two years after their second dose.⁴ That means that we don’t know and we won’t know for about two more years. In that time, how many young, growing bodies will be vaccinated? Millions.
What is the dose given to adolescents?
The dose for growing 12-15-year-old adolescents is the same as the adult dose. It does not vary by age nor weight like many other medications.
What are the possible side effects of the vaccine in adolescents?
The same side effects seen in adults are seen in the 12-15-year-old age range. However, with the robust immune system these growing bodies have, they will potentially mount a stronger immune response faster. As we know, that’s not always positive. For a list of known side effects, visit the required patient handout at www.cvdvaccine.com. As the study continues for two more years, it will be important to continue to monitor during that time. The VAERS (Vaccine Adverse Events Reporting System) is updated weekly on Friday with reported adverse events. It has been reported that less than 10% of adverse reactions are recorded on the system.
Doctors have questions too.
It’s not just parents who are asking questions. Many doctors around the world are also questioning whether vaccinating adolescents and children is a wise move. Jennie S. Lavine, researcher, recently published an article in the BMJ, one of the world’s oldest peer-reviewed medical trade journals, stating, “Young people have been largely spared from severe covid-19 so far, and the value of childhood vaccination against respiratory viruses in general remains an open question for three reasons: the limited benefits of protection in age groups that experience only mild disease; the limited effects on transmission because of the range of antigenic types and waning vaccine induced immunity; and the possibility of unintended consequences related to differences in vaccine induced and infection induced immunity.⁵
An associate professor from the University of Leeds, made an interesting statement. “Given that the vaccine is safe in other age groups, we should not expect problems in this age group. The study size was not large when looking for uncommon side effects; but it may have been sufficient,” said Stephen Griffin.⁶ Those uncommon side effects and the thought that the study may have been sufficient leads to more questions than answers for some.
Many are also waiting for the peer-review to come regarding the study. With few details being released thus far, there are still several questions to have answered.
The CDC’s advisory committee met Wednesday, May 12, to review safety and efficacy data and voted to recommend the vaccine for this new age bracket. Many states prepared to have the vaccine available to adolescents as early as the next day. However, some states such as Delaware and Georgia began offering and administering the vaccine ahead of the CDC vote.
The trials continue with 5-11-year-olds being the next age group to be studied as well as pregnant women. Children as young as 6 months have received their first dose for study. In these categories, trials will be done to determine the recommended dosing. In the older populations, this was done in a high, mid-range, and low dose with side effects and immune responses monitored to determine a safe dose.
For more information on the trial studies in progress, visit: https://clinicaltrials.gov/ct2/show/NCT04816643?cond=COVID-19&age=0&draw=2&rank=4