Cincinnati Children’s Hospital part of study for possible COVID-19 vaccine

CINCINNATI (FOX19) - Cincinnati Children’s Hospital Medical Center is part of global study for a potential coronavirus vaccine for Pfizer and the German pharmaceutical company BioNTech, the companies announced Tuesday.

The first human volunteers received doses of the BNT162 vaccine program in Germany last month, the news release states.

They will test it here in the U.S. on 360 healthy volunteers between the ages of 18 and 55 in the first phase of the study and up to 8,000 volunteers by the second stage.

New York University’s Grossman School of Medicine and the University of Maryland School of Medicine are among sites currently giving doses to study participants.

Cincinnati Children’s Hospital Medical Center and University of Rochester Medical Center/Rochester Regional Health will begin enrollment shortly, according to the release.

If the tests are successful, the vaccine could be ready for emergency use as early as September.

“With our unique and robust clinical study program underway, starting in Europe and now the U.S., we look forward to advancing quickly and collaboratively with our partners at BioNTech and regulatory authorities to bring a safe and efficacious vaccine to the patients who need it most," said Albert Bourla, Chairman and CEO of Pfizer.

“The short, less than four-month timeframe in which we’ve been able to move from pre-clinical studies to human testing is extraordinary and further demonstrates our commitment to dedicating our best-in-class resources, from the lab to manufacturing and beyond, in the battle against COVID-19.”

Cincinnati Children’s said in a statement Tuesday it will enroll up to 90 participants in the first stage of the study.

Recruitment and screening are underway with initial administrations of candidate vaccine in Cincinnati expected to begin in the next two weeks.

The study at Cincinnati Children’s is led by Robert Frenck, MD, Director of the NIH-funded Vaccine and Treatment Evaluation Unit (VTEU) and Gamble Program for Clinical Studies, Children’s Hospital officials said in a news release.

The program is a national leader in vaccine research and one of nine NIH VTEUs in the U.S. It is testing vaccines for several global health challenges like Ebola, influenza and now COVID-19.

Despite international efforts to develop vaccines and drugs to stem the tide of COVID-19, the most important step people can take to protect themselves is to avoid infection, Frenck said.

“COVID-19 is a virus to which people have not been previously exposed, so everyone is susceptible to getting the infection,” Frenck said.

“While social distancing is effective, it is difficult to maintain long term. We are excited about this vaccine and think it has the possibility to decrease the risk of infection from COVID-19.”

The prospective vaccine works by having our body make a piece of the virus called the spike protein, Frenck said. The body then makes antibodies to the spike protein designed to protect people against COVID-19 should they be exposed to the virus.

Frenck emphasized that study participants will not be given the whole virus, making it impossible to get COVID-19 from the vaccine.

To find out if you are eligible for current or future studies, fill out their screening questionnaire or call 513-636-7699 or email gambleprogram@cchmc.org .

The government’s top medical expert, Dr. Anthony Fauci, has said we could have a vaccine by January.

Another wave of coronavirus could hit this fall, but it’s not clear yet how severe it could be, he also has said.

Coronavirus: The global race for a vaccine

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