“As of now, we do not have a vaccine that is authorized for use in children under age 12,” said Gary S. Marshall, chief of pediatric infectious diseases at Norton Children’s and the UofL School of Medicine, and principal investigator for the Louisville trial. “Having a safe and effective vaccine for children will not only keep them healthy but also would facilitate a return to normal in terms of school and other activities.”

In the randomized clinical trial, two children will be assigned to receive the vaccine for every one child who receives a placebo. The study is blinded, meaning that no one initially will know which injection they receive. Parents and caregivers will be asked to track changes to the child’s health in an electronic diary, and children will have at least six in-person visits over a two-year period, some to include blood draws.

Children who are randomly assigned to receive the placebo will be given the chance to receive the active vaccine after six months; therefore, all children in the study ultimately will have the opportunity to receive the active vaccine.  

The vaccine being studied is the same one that has been authorized for people ages 12 and older. In adults, this vaccine demonstrated 95% efficacy against COVID-19, and as of May 2021, nearly 140 million people in the U.S. had received at least one dose. Preliminary data show the vaccine to be safe in children as well as able to generate a strong immune response.

The research team plans to enroll about 100 local volunteers for the trial; the overall enrollment will be about 4,500. Children ages 6 months to 11 years who are generally healthy are eligible to be included.

“The Pfizer-BioNTech vaccine has been shown to be very safe and effective in adults and adolescents,” said Kimberly A. Boland, chief of staff, Norton Children’s Hospital, and department chair, UofL School of Medicine Department of Pediatrics. “We have every reason to believe this study will show the vaccine to be safe and effective in children and an important step forward for children’s health and for protecting our communities.”

Marshall is known for his work in vaccine development, advocacy and education. In fact, he has worked on many of the vaccines that children routinely receive today.

The clinical trial team has responded to the pandemic, treating children with COVID-19 and its consequences.

“This is the most exciting vaccine trial I have ever been involved with, and I’ve been doing this for over 30 years,” Marshall said.

Parents and caregivers can sign children up to be considered for the trial by going to .

 “Today is a historic day in the commonwealth – we are at the beginning of the end of our war with COVID-19,” said Gov. Beshear, who was at UofL Hospital as UPS delivered the vaccines. “The Pfizer vaccine, which we believe to be 95% effective, is the defense we have needed to end this pandemic, and with the highly effective Moderna vaccine likely on its way to approval soon, we are all filled with hope for the first time in a very long time. Thank you to everyone who helped make this possible. To our front-line workers: we are forever grateful for your bravery, talents and compassion.”

The Governor watched as five UofL Health doctors and nurses, who have been working on the front lines to help Kentuckians during the once-in-100-years pandemic, received their vaccinations in public and before the media. Sarah Bishop, director of infection prevention at UofL Hospital, administered the vaccinations to all five.

Dr. Jason Smith, a front line emergency and trauma surgeon and UofL Health chief medical officer was the first to receive the vaccine.

“The arrival of this vaccine demonstrates the best of medicine and our commonwealth’s collaborative spirit,” said Dr. Smith. “For the first time, we now have a tool to minimize the spread of COVID-19 in a significant way. I appreciate the leadership of Gov. Beshear and UPS working to expedite getting this vaccine to our frontline health care workers. And I am humbled by the ongoing individual sacrifices of so many Kentuckians who continue to help through social distancing and masking until the vaccine is more widely available to the general population.”

Two UofL Health nurses and two UofL Physicians were the next in line.

LaShawn Scott has worked for UofL Health for more than 20 years as an infection prevention nurse. Scott has worked tirelessly to help support our front-line staff in ensuring they have the PPE they need and know how to use it correctly and making sure the health care system has protocols in place to help the frontline staff stay safe as they battle the pandemic.

Beth Sum is an emergency department nurse at UofL Health and a nurse educator at UofL Health – Jewish Hospital. She has been instrumental at caring for and developing nursing protocols around COVID-19 care in the emergency department.

Dr. Valerie Briones-Pryor has been with UofL Health for over 16 years. She has been working with COVID-19 patients at UofL Health – Jewish Hospital since March 17, and said she lost her 27^th COVID-19 patient Monday morning.

“I did this for them, for all of my patients,” said. Dr. Briones-Pryor. “I was honored to be one of the first five to receive this vaccine.”

Dr. Muhamed Saad is the director of critical care at UofL Health – Jewish Hospital. Throughout the pandemic, he has taken care of all COVID-19 ICU patients throughout the UofL Health system.  

The initial shipment of the two-dose Pfizer-BioNTech COVID-19 vaccines arrived in Kentucky on December 13, 2020.

Bacteria called Group B Streptococcus or Streptococcus agalactiae (Group B strep, GBS) commonly live in people’s gastrointestinal and genital tracts. Most of the time, the bacteria are not harmful and do not make people feel sick or have any symptoms. Sometimes, however, the bacteria invade the body and cause certain infections, which are known as GBS disease. GBS bacteria can cause bacteremia (bloodstream infection) and sepsis (the body’s extreme response to an infection), meningitis, pneumonia, bone and joint and skin and soft-tissue infections. An invasive GBS infection is one that involves blood or internal organs, whereas a noninvasive infection could involve skin or other soft tissue, the urinary tract or bones and joints.

Previous studies describing the burden of GBS infection in adults have primarily focused on invasive disease because existing surveillance systems rely on blood culture collection. In the new study, however, non-invasive disease was three to four times more common than invasive disease, suggesting that adult GBS burden is considerably greater than previously recognized. Of the infections reviewed, 79% were non-invasive. In 60% of the infections, GBS was identified as the only pathogen.

“These new data suggest that the burden of GBS infection is considerably greater than previously recognized in earlier surveillance studies that only focused on invasive disease, ” said Julio Ramirez, MD, chief of the Division of Infectious Diseases at UofL. “Importantly, we found that the rates of GBS infection in this study are comparable to that of other adult infections for which vaccines are routinely recommended, which underscores the need for developing approaches for preventing this infectious disease among an aging adult population.”

In conducting the study, the researchers reviewed laboratory and medical records from six hospitals in Louisville between Jan. 1, 2014 and Dec. 31, 2016. Louisville’s population is generally similar to the United States in terms of demographics and prevalence of underlying chronic medical conditions.

Rates of GBS-associated hospitalization were significantly higher in adults 65 years and older, African Americans and people with underlying chronic medical conditions such as obesity, diabetes, chronic renal disease and coronary artery disease. The finding that obesity and diabetes put patients at increased risk for GBS-associated hospitalization is especially noteworthy given that recent Centers for Disease Control and Prevention reports have highlighted that 42% of U.S. adults are obese and that as many as 34 million American adults (roughly 13% of all U.S. adults) have diabetes, with another 88 million having pre-diabetes.

Additional findings from the study included the following:

• Annual rates of GBS infection in African American adults were 2.6 times higher than in white adults, or 157 per 100,000 in African American vs. 60 per 100,000 in white adults.
• Compared with the general population, annual GBS infection rates were 2 to 6 times higher among adults with underlying chronic medical conditions, such as chronic kidney disease, diabetes, obesity or heart disease.

“This type of study, evaluating both invasive and non-invasive GBS infections, is essential for understanding the full spectrum of GBS disease burden among adults,” said John M. McLaughlin, PhD, Global Epidemiology and Scientific Affairs Lead, Pipeline Vaccines, Pfizer Inc., and the lead study author. “These data should aid health care providers with clinical decision-making. Our population-based study gives the first estimates of total annual GBS burden in the United States, emphasizing the importance of preventive efforts in the growing population of adults who are older or have chronic medical conditions, and will inform future vaccination strategies.

In January, Pfizer launched its , a global program of collaborations with academic institutions to conduct real-world epidemiologic research to accurately identify and measure the burden of specific vaccine-preventable diseases and potentially evaluate vaccine effectiveness in adults. At that time, the UofL Division of Infectious Diseases was designated as the first . This collaboration is aimed at determining the human health burden of important infectious diseases and potential vaccine effectiveness

The GBS collaborative study between UofL and Pfizer was completed prior to the university being named as Pfizer Vaccine’s first Center of Excellence site.

UofL has been designated the first Center of Excellence by Pfizer Vaccines.

“UofL’s Division of Infectious Diseases has a rich history of collaboration with Pfizer through the successful implementation of numerous clinical epidemiological research studies. We are excited to formalize a long-term collaboration that builds on these past successes,” said Julio Ramirez, MD, chief of the Division of Infectious Diseases at the .

The Center of Excellence, directed by Ramirez, is a collaboration between the university and the pharmaceutical corporation aimed at determining the human health burden of important infectious diseases and potential vaccine effectiveness. The data will provide robust evidence to national health officials and independent policy makers who develop recommendations for the use of vaccines in immunization programs worldwide. Studies will take place in hospitals, long-term care facilities and the community.

UofL is the first Center of Excellence selected by Pfizer Vaccines Medical Development and Scientific/Clinical Affairs to be part of an international network of epidemiological research organizations. This designation is for a period of three years with an option for renewal. Pfizer selected UofL because of the university’s exceptional capabilities for conducting population-based surveillance and clinical research that engages multiple health care facilities, health care personnel, industry and communities-at-large.

“Pfizer has had an outstanding working relationship with the University of Louisville for more than 10 years,” said Luis Jodar, PhD, chief medical and scientific affairs officer, Pfizer Vaccines. “The quality of disease burden evidence varies widely worldwide. Deriving accurate and credible population-based incidence estimates require comprehensive surveillance to identify cases of diseases within a well-defined and well-characterized geographic area. Thanks to UofL’s excellent network of research partners, the population available for research studies in Louisville can provide the data to derive estimates of disease burden that can be generalized nationally.”

The demographics of Jefferson County, Kentucky, are similar to the United States in general, including racial and ethnic make-up, socioeconomic status, and the proportion of rural and urban populations.

The research studies conducted as part of the center may lead to economic growth and development for the city of Louisville and the Kentuckiana region, including jobs and educational opportunities in the health care industry.

“This collaboration will provide increased visibility for the university on a global scale, making UofL attractive for high-caliber researchers and research grants,” said Neeli Bendapudi, PhD, president of UofL. ”It also presents an exceptional opportunity for our researchers to improve the human condition by helping to reduce the burden of infectious diseases worldwide by generating data that will inform governments and health care policymakers.”

Pfizer studies anticipated for UofL include population-based surveillance of infectious diseases including Streptococcus pneumoniae, a bacteria which causes pneumonia and other infections, Clostridioides difficile, a bacteria that causes severe diarrhea and colitis, and respiratory syncytial virus (RSV), a common virus associated with mild cold-like symptoms but can cause severe infection in some people, including older adults. Visit for additional information on these diseases and two Center of Excellence studies already underway at UofL:

• The City of Louisville Diarrhea (CLOUD) study launched in September 2019. Pfizer will be providing up to $6.5 million in funding for a one-year study of the incidence of diarrhea among Louisville-area residents.
• The Louisville Pneumonia study is up to $4.5 million in funding provided by Pfizer for a one-year study of the incidence of pneumonia among adults in Louisville that launched in November 2019.

Check out the video for more information: