Ochsner Hospital for Children announced its participation as a Pfizer Inc. and BioNTech SE study site for the Phase 2/3 global study of the investigational COVID-19 vaccine. Originally introduced in late July 2020 for adult volunteers ages 18-85 and November 2020 for adolescents ages 12-17, the Pfizer Phase 2/3 trial – with U.S. Food and Drug Administration (FDA) emergency approval – is now seeking children volunteers ages 5-11, with the goal of enrolling children as young as six months old in the near future.
The Phase 2/3 trial will enroll a total of more than 4,000 children globally with Ochsner enrolling as many 75 participants. Ochsner is one of two locations in Louisiana to offer the study and their research team is currently in the selection process for the 5-11-year-old age group.
“Now that the vaccine has proven to be effective in adults, it is a natural next step in the research process to study the unique needs of younger individuals. A child’s immune system is different than an adult’s immune system, so it is critically important to have a study focused on the efficacy of the vaccine in this cohort,” said Dr. Julia Garcia-Diaz.
The Phase 2/3 trial is designed to obtain safety, immune response and efficacy data needed for regulatory review and is looking to determine whether the vaccine produces an immune response and prevents COVID-19 in children ages six months through 11 years old. The study is placebo-controlled, meaning 25% of the participants will be randomly assigned to receive placebo, while others will receive the vaccine. Participants will receive two doses three weeks apart and neither the patients nor the research investigators will know what they have received.
The trial will continue for 18 more months, during which both groups will undergo blood draws to track the strength and duration of their immune response and to see if they are infected with COVID-19. For this current enrollment, participants must be in the age range of 5-11 years-old at the time of enrollment, and approved guardian consent. Six months after the second injection, all participants will be unblinded and those who received the placebo in the Phase 2/3 portion of the study will have the opportunity to be inoculated with the actual vaccine.
If you or someone you know are interested in participating in COVID-19 research opportunities at Ochsner, email COVIDVaccine@ochsner.org.