Ochsner Health Announces First Enrollment for Pfizer Inc. and BioNTech SE Phase 2/3 Study of Investigational Vaccine Against COVID-19

State News

(C.S. Goldsmith / A. Tamin / CDC / AP)

NEW ORLEANS, La. (KTVE/KARD) — According to Ochsner Health, they’ve announced plans to participate as a study site for the phase 2/3 global study for COVID-19.

The study is sponsored by Pfizer Inc. and BioNTech SE to discover a vaccine for COVID-19.

The health system has had multiple participants enroll in the study.

Ochsner is one of 120 clinical investigational sites throughout the world that will, collectively, enroll up to 30,000 active participants and is one of only two locations throughout Louisiana to offer the study.

The vaccine investigation will be led by Ochsner’s Principal Investigator, Dr. Julia Garcia-Diaza, who is the Director of Clinical Infectious Diseases Research and Infectious Disease Specialist.

The study will enroll a limited number of randomly picked participants selected from an already existing pool of candidates from across Louisiana who expresses interest in COVID-19 research.

The team has already began the selection process.

Louisiana has been a COVID-19 hot spot for quite some time, and we know that the development of a vaccine is the best way to further protect our patients and community from this virus. Ochsner was selected for our expertise and excellence in conducting clinical trials. This study is another tangible way we continue to play a significant role in supporting treatment, prevention and testing advances through research and clinical trials.

Dr. Leonardo Seoane, Chief Academic Officer, Ochsner Health

Ochsner has a long history of being at the forefront of innovation, research and clinical trials. Being at the center of this unprecedented pandemic is no different. With a population who has an increased prevalence of being high-risk and who suffers from chronic disease, we are proud to be a selected site for this vaccine study and remain committed to fighting this disease and stopping the spread in our communities.

Dr. Julia Garcia-Diaza

Ochsner says the Phase 2/3 study is an event driven trial which will continue enrollment throughout the study, enrolling up to 30,000 participants at 120 clinical investigational sites around the world.

Participants who are accepted into the study will be randomized to receive either the vaccine or placebo. All participants will receive two shots; 50% will receive the vaccine and 50% will receive a placebo; neither the patients nor the investigators will know which one they have received.

The Phase 2/3 trial is designed as a 1:1 investigational vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response and efficacy data needed for regulatory review.

The trial’s goals will be prevention of COVID-19 in those who have not been infected prior to immunization, prevention of COVID-19 regardless of whether participants have previously been infected and the prevention of severe COVID-19 in those groups. 

To learn more about Ochsner’s COVID-19 response, please visit www.ochsner.org/coronavirus.

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