On September 10, 2021, the Acting Commissioner of Food and Drugs, Janet Woodcock, M.D., and Director of the Center for Biologics Evaluation and Research, Peter Marks, M.D., PhD., issued a statement on behalf of the FDA regarding the vaccination of children under the age of twelve. The FDA noted there are different issues that need to be addressed in pediatric vaccine trials, including “whether there is a need for different doses or different strength formulations of vaccines already used for adults.”

The statement highlights steps the FDA is taking to “ensure the safety and efficacy of these products for children:”

  1. Clinical trials involving children participants is underway.
  2. Manufacturers will then analyze data from their respective studies to understand the safety and efficacy of the vaccines for children. Once that analysis meets robust regulatory standards, the manufacturers compile the information and can “request an emergency use authorization (EUA) or submit for approval a biologics license application.”
  3. The FDA “carefully, thoroughly and independently” examines the data to evaluate the risks and benefits exhibited in the data.

The FDA assured it has not, and will not, cut any corners during its evaluation process. But regarding whether parents should vaccinate their children now, the FDA stated, “It is important for the clinical trials to be completed before vaccinating young kids, so the FDA’s team can conduct a thorough evaluation and ensure the data show that the vaccine under consideration is likely to work to prevent COVID-19 in young children and doesn’t cause unexpected safety issues separate from those that have already been observed in adolescents and adults.”

Instead, it is “important that parents and others who interact closely with children under 12 years of age get vaccinated, wear masks, and follow other recommended precautions so that we can protect those who cannot yet protect themselves through vaccination.” Individuals over the age of twelve continue to be eligible for the vaccine at this time, including adolescents aged twelve through fifteen.

Norton Rose Fulbright lawyers will continue to provide relevant updates for healthcare providers on the Health Law Pulse during the COVID-19 public health crisis.