Academic Medical Centers Prepare to Launch Pfizer Third Booster Shot Clinical Trial

Academic Medical Centers Prepare to Launch Pfizer Third Booster Shot Clinical Trial

While Pfizer recently asked the U.S. Food and Drug Administration (FDA) to consider a third booster dose targeting COVID-19, that triggered an international discussion, from enthusiasm in nations such as Israel and the UK to angst and anger from the World Health Organization (WHO) emphasizing vaccine equity to a noticeable sense of tension with the government, as represented by an interview involving Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institute of Health (NIH). Pfizer’s CEO had to call Fauci to apologize as reported by TrialSite. The Pfizer announcement triggered a unified government response reported on by TrialSite, declaring no booster was needed at this time. Yet numerous health systems seek out more information about such a third shot. Now a large new global study involving 10,000 participants investigates the question. Among those trial sites participating, Cincinnati Children’s Hospital is on a quest to determine the actual need for a booster. 

The Potential Problem

Reports out of Israel and the UK suggest, for example, that the Delta variant impacts the efficacy of the current crop of vaccines, including Pfizer-BioNTech’s mRNA-based BNT162b2. According to a recent report from UMass, thus far, there appear to be few “breakthrough” cases associated with the Delta variant but again that may turn out not to be the case.

The Hypothesis

As reported recently by Dr. Robert Finberg with UMass School of Medicine: “The vaccine has obviously been shown to be incredibly effective for six months” but, “The question is, what happens after that? So, this is going to be a Phase 3 trial of 10,000 people across the world and they’re going to be randomized to either get a placebo or a third shot of the same vaccine that they had two doses of.” The study age group ranges from 16 to 55 years of age.

Cincinnati Children’s Hospital joins UMass Medical School and numerous other trial sites to participate in the trial testing the Pfizer COVID-19 booster vaccine.

Cincinnati Children’s Hospital POV

Dr. Robert Frenck helps lead the charge at Cincinnati Children’s Hospital for the study. Recently, on local news, he declared, “You need to have the data so you can make predictions about when to give the booster and who may need a booster.”