Pfizer announced last week that it has received the Food and Drug Administration’s [FDA] approval to enroll children as young as 12 years old in its COVID-19 vaccine trial. A vaccine first, the trial is aimed at understanding whether it would be safe and effective for adolescents.
In September 2020, Pfizer expanded the enrollment of its Phase 3 COVID-19 vaccine trial to approximately 44,000 participants.
This allowed for the enrollment of new populations, including adolescents as young as 16 years of age and people with chronic, stable HIV, Hepatitis C, or Hepatitis B infection.
“In October 2020, we received permission from the FDA to enroll adolescents as young as 12. By doing so, we will be able to better understand the potential safety and efficacy of the vaccine in individuals from more ages and backgrounds,” Pfizer said on its site.
Health experts say including younger children in clinical trials are critical as more and more are being infected with COVID-19, the disease caused by the coronavirus.
In a letter sent earlier this month to Alex Azar, Secretary of the U.S. Department of Health and Human Services, and Stephen Hahn, commissioner of the FDA, the American Academy of Pediatrics [AAP] wrote, “children must be included in vaccine trials to best understand any potential unique immune responses and/or unique safety concerns.”
Sara Goza, president of the AAP added, “As pediatricians, we must also stress how crucial it is for children to be included in vaccine trials of SARS-CoV-2 vaccines.”
“While some studies have shown that children under the age of 10 may be less likely to become infected and less likely to spread the virus to others, more recent data suggest children older than 10 years may spread SARS-CoV-2 as efficiently as adults.”
Goza says while the likelihood of spreading the disease may vary among different aged children, experts know that children can and do spread the virus to household members, grandparents, teachers, and other children.
“In fact, in the United States alone, more than 587,000 COVID-19 cases have been reported in children, representing approximately 10 percent of all cases,” she said.
“Among the children who have acquired COVID-19, 109 have died from the virus, with more than two-thirds being Black and Latinx children.”
In a report released last month, the Centers for Disease Control and Prevention (CDC) found that between Feb. 12 and July 31 of this year, there were more than 390,000 cases of COVID-19 and 121 deaths for people under 21.
Of the children who died, 45 percent were Hispanic, 29 percent were Black, 4 percent were non-Hispanic American Indian or Alaska Native and 33 percent of the deaths occurred outside of a hospital.
“Among infants, children, and adolescents hospitalized with laboratory-confirmed COVID-19, persons from racial and ethnic minority groups are overrepresented,” the report said.
“These racial/ethnic groups are also disproportionately represented among essential workers unable to work from their homes, resulting in higher risk for exposure to SARS-CoV-2 with potential secondary transmission among household members, including infants, children, adolescents, and young adults.”
Three-quarters of the children who died in the given timeframe had underlying conditions such as asthma, obesity and cardiac issues, according to the CDC.
“Higher rates of adverse outcomes among racial and ethnic minorities are likely related to challenges in seeking care for various reasons, including difficulty and delays in accessing health care services because of lack of insurance, child care, transportation, or paid sick leave,” the report stated.
The report added that factors such as crowded living conditions, food and housing insecurity, wealth and educational gaps and racial discrimination, likely contribute to racial and ethnic disparities seen in all ages in COVID-19 infections and mortality.