Finding that its COVID-19 vaccine is safe and effective in adolescents, Pfizer has sought emergency use authorization of the vaccine for kids ages 12 to 15 from the U.S. Food and Drug Administration (FDA). The 2-dose mRNA vaccine is already approved for use in teens and adults age 16 and older.
Summarizing the results of its U.S. trial of the vaccine in 2,260 adolescents, the company said it demonstrated “100% efficacy and robust antibody responses.” In the trial, 18 cases of COVID-19 were observed in the placebo group, which included 1,129 participants, and no cases were reported in the vaccinated group of 1,131 participants. Additionally, the vaccine was well-tolerated by participants, with only mild side effects noted.
A well-timed approach to ending the pandemic
This development comes just as several local school districts are welcoming students back on campuses and youth sports have begun in-person training and competition. The news also arrives as the American Academy of Pediatrics (AAP) reports a slight uptick in COVID-19 cases in children.
According to the AAP, there have been more than 3.5 million reported COVID-19 cases in children in the U.S. since the beginning of the pandemic, with kids representing 13.5% of overall cases. Recently, there have been increases in newly reported child cases, with children representing nearly 19% of new cases in the first week of April.
While severe illness from COVID-19 is rare among children, there is still concern there may be long-term impacts on the health of children who were infected. A very small number of children with COVID-19 or who had a prior infection experience multisystem inflammatory syndrome (MIS-C), a rare, life-threatening condition that can cause dangerous inflammation in the eyes, skin, blood vessels and heart.
“Our focus throughout the pandemic has primarily been on those at highest risk of severe illness, especially those age 65 and over,” says Dr. Howard Smart, chair of Pediatrics at Sharp Rees-Stealy Medical Group. “Now that millions of adults across the country have received at least 1 dose of a COVID-19 vaccine and are on their way toward full protection, it is important to ensure that children are equally protected. The availability of a safe and effective vaccine for kids age 12 and over is a great step toward this goal.”
The relationship between youth sports and a rise in cases
While kids and parents welcome the return of in-person education and activities, the director of the Centers for Disease Control and Prevention (CDC) advises that we should remain vigilant. This is especially true as clusters of cases across the country associated with youth sports and extracurricular activities have been reported in recent weeks.
Many of these new cases have been caused by virus variants, such as the one first detected in the U.K. This particular variant is thought to be more contagious and is now the most common COVID-19 variant in the U.S.
Experts worry practices, competitions and other activities related to youth sports, such as carpooling and team parties, might provide opportunities for transmission — not only to youth participants, but also to their coaches, game officials and parents who are not yet vaccinated. Close-contact indoor sports, such as wrestling, basketball and hockey, are of particular concern.
“We have seen how happy and relieved the vaccinated adults in our community are as they move toward being able to safely return to some of their beloved activities and traditions,” Dr. Smart says. “With the safe vaccination of children on the horizon, we look forward to their protection as they return to school, social activities, sports and more, as well as further protection of the adults around them.”
How soon the vaccine might be available for kids
Dr. Janet Woodstock, acting commissioner of the FDA, has said that the agency will review Pfizer’s request and evaluate the provided data as quickly as possible. While she stated that the FDA cannot predict how long it will take to determine whether or not it will recommend emergency use authorization of the vaccine for adolescents, the agency is committed to a transparent, science-based approach.
Pfizer and other drug companies, including Moderna and AstraZeneca, have also begun vaccine trials in younger children that will eventually include babies as young as 6 months old. Some results from those trials are expected in the second half of 2021, and Pfizer states it hopes to receive authorization for vaccination of younger children by early 2022.
Even after vaccination becomes available to children, experts caution that everyone — children and adults — should continue to practice COVID-19 prevention measures, as it is unknown if people can spread the virus after being vaccinated. This includes regular hand-washing, wearing a mask, and social distancing when in public and when spending time with unvaccinated people from multiple households, or with people who are unvaccinated and at greater risk for severe COVID-19 illness.