Clinical trials are creating cautious optimism for the development of an effective vaccine. University Hospitals is playing a key role in the Pfizer and BioNTech Phase 2/3 global investigational study of a SARS-CoV-2 vaccine. UH is one of approximately 120 clinical investigational sites worldwide and the only site in Northeast Ohio. More than 40,000 individuals, ranging in age from 12 years old and up, have enrolled in the study including 160 people at the UH clinical site.
“This vaccine has been the most important clinical study I have ever been involved in, given the ramifications of the pandemic and where we need to head,” says Dr. Robert Salata, chairman of the department of medicine at UH and principal investigator for the study.
The Pfizer and BioNTech study is a 1:1 investigational randomized study in which an equal ratio of candidates receive the vaccine or the placebo. The trial’s primary goals are to determine the safety and effectiveness of the vaccine to generate antibodies and an immune or resistant response.
“We’re very excited that the preliminary data shows a vigorous antibody response which is up to 20 times higher then what we see in many individuals who have been naturally exposed and develop the infection,” says Salata. “If we can reach an antibody response of 70% immunity, or resistance, in the general population, the number of COVID cases should come down substantially.”
Salata estimates that while some vaccines will be available later this year or in early 2021, distribution to the general public will be in late spring or summer. “By the end of 2021, we will be in a very different place,” he says. “In the meantime, we hope we will be building up some degree of herd immunity.”