Evaluating The Safety of COVID-19 Vaccines
With the rolling out of COVID-19 vaccines at a record pace, investigators in the division led by Elizabeth Schlaudecker, MD, MPH, and Mary Staat, MD, MPH, are key in establishing vaccine safety and evaluating adverse events. Schlaudecker leads the CDC-funded CISA (Clinical Immunization Safety Assessment) Project at Cincinnati Children's and is a national expert in the evaluation of the safety of COVID-19 vaccines. Through the CISA Project, Schlaudecker and Staat provide consultation for complex COVID-19 vaccine safety questions for medical providers around the country. In collaboration with investigators at the CDC, they are investigating the safety of simultaneous administration of COVID-19 and influenza vaccines, and the safety of COVID-19 vaccination in special populations.
Gamble Vaccine Program Leading Evaluation of COVID-19 Vaccines
Robert Frenck, MD, and colleagues at the Gamble Vaccine Research Center were one of four sites in the country selected to conduct phase 1 testing on the Pfizer vaccine in adults, and the only site in the US conducting phase 1 trials in both children and adults. The Gamble program was key in evaluating the Astra-Zeneca and Moderna COVID-19 vaccines in multiple trials. In total, there were over 1500 people enrolled in COVID-19 vaccine-related clinical trials. This was instrumental to the US Food and Drug Administration (FDA) in providing emergency use authorization (EUA) for these life-saving vaccines. The work of Frenck and his team on COVID-19 vaccines resulted in a publication in Nature, and five publications in the New England Journal of Medicine (NEJM), including the phase II / III Pfizer COVID-19 vaccine in adults and the lead author for the article outlining the vaccination of adolescents with the Pfizer vaccine. The phase II / III Pfizer study is the third most cited article for any study published in NEJM and the 13th all-time.