During its June 10 meeting on pediatric COVID-19 vaccination, the FDA focused on safety, efficacy and how the shots would mix with other vaccines, according to Politico.
Since children's developing immune systems seem to react to the coronavirus differently than the adults, the agency is prioritizing safety. Clinical trials are underway to determine COVID-19 vaccines' side effects in children, but some rare conditions may only emerge when the vaccine is already in wide use among children. A possible way to address this is to conduct large studies over a small period of time, rather than observe a small group of vaccinated children over a longer period.
Additionally, the FDA is concerned about how effective COVID-19 vaccines are in children. Clinical trials usually measure vaccines' efficacy by comparing symptomatic infections in vaccinated participants versus participants who received a placebo. Since symptomatic COVID-19 infection is less likely in children than adults, it could take a long time for clinical trials to reach the FDA's statistical requirement for efficacy. The agency may take a different approach to measuring efficacy, such as analyzing the amount of antibodies children produce post-vaccination.
Since most routine vaccinations are administered during childhood, the FDA is also working to determine whether administering COVID-19 vaccines alongside other shots will reduce efficacy or lead to more severe side effects.