Ochsner Hospital for Children To Enroll Children in Pfizer Phase 2/3 Investigational Vaccine Study Against COVID-19
The System Is One of Two Locations in LA to Participate in Study
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 which 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 adolescent and the Janssen ENSEMBLE vaccine trial.
If you or someone you know are interested in participating in COVID-19 research opportunities at Ochsner, please email COVIDVaccine@ochsner.org.
To learn more about COVID-19 vaccines, please visit www.ochsner.org/vaccines.
About Ochsner Health
Ochsner Health is a system that delivers health to the people of Louisiana, Mississippi and the Gulf South with a mission to Serve, Heal, Lead, Educate and Innovate. Ochsner Health is a not-for-profit committed to giving back to the communities it serves through preventative screenings, health and wellness resources and partnerships with innovative organizations that share our vision. Ochsner Health healed more than 900,000 people from across the globe in 2020, providing the latest medical breakthroughs and therapies, including digital medicine for chronic conditions and telehealth specialty services. Ochsner Health is a national leader, named the top hospital in Louisiana and a top children’s hospital by U.S. News & World Report. As Louisiana’s leading healthcare educator, Ochsner Health and its partners educate thousands of healthcare professionals annually. Ochsner Health is innovating healthcare by investing in new technologies and research to make world-class care more accessible, affordable, convenient and effective. Ochsner's team of more than 32,000 employees and 4,500 providers are working to reinvent the future of health and wellness in the region. To learn more about Ochsner Health, please visit www.ochsner.org.