NEW ORLEANS – 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.
Led by Ochsner Principal Investigator Dr. Julia Garcia-Diaz, Director of Clinical Infectious Diseases Research and Infectious Disease Specialist and Dr. William Lennarz, System Chair of Pediatrics, 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.
Dr. Lennarz added, “Children have been seriously impacted by COVID in many ways – physically, emotionally, and educationally. From schools closing unexpectedly during the height of the pandemic to the risk of developing pediatric multisystem inflammatory syndrome – a serious inflammatory response that affects multiple organs, including the heart – we recognize that children have been seriously impacted by the COVID-19 pandemic. Ochsner Hospital for Children played an active role in proving the efficacy of the Pfizer vaccine for youth 12 to 15 and we remain committed to continue working towards the identification of a safe and effective vaccine for children of all ages.”
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.
Ochsner remains committed in playing a key role in the search for a solution to build immunity against COVID-19. With more than 30 COVID-19 clinical trials, the health system participated in the Pfizer vaccine trial for adults and adolescents and the Janssen ENSEMBLE vaccine trial.
To learn more about COVID-19 vaccines, visit //www.ochsner.org/vaccines.