Evaluating COVID-19 Vaccines in Children and Adults

Robert Frenck, MD, and colleagues, including Grant Paulsen, MD, and Rebecca Brady, MD, at the Gamble Vaccine Research Center continue to be national leaders in the testing of COVID-19 vaccines. Based on the expertise within the center, they are one of the few units in the country that tested COVID-19 vaccines across age ranges, with participants ranging from 6 months to 85 years of age. Their work has been instrumental in the U.S. Food and Drug Administration’s (FDA) initial provision of Emergency Use Authorization (EUA) for these life-saving vaccines in adults as well as extending the EUA to children as young as 6 months of age this year. This year, their research resulted in nine publications in peer-reviewed journals, including four in the New England Journal of Medicine (NEJM). Additionally, the team provided innumerable interviews resulting in a projected 8.25 billion hits.

In addition, the center recently re-started pandemic-delayed studies evaluating vaccines against common causes of diarrheal diseases, including shigella, campylobacter and norovirus, utilizing our inpatient facility, one of the largest within the nine center NIH funded vaccine treatment and evaluation unit.

Evaluating the Safety of COVID-19 Vaccines

In collaboration with the CDC’s CISA (Clinical Immunization Safety Assessment) Project, Elizabeth Schlaudecker, MD, MPH, and Mary Staat, MD, MPH, continue to evaluate vaccine safety and adverse events after vaccination and provide consultation for complex vaccine safety questions for medical providers around the United States. In collaboration with the CDC this year, Schlaudecker and Staat published investigations of multisystem inflammatory syndrome and myocarditis cases in adults and children after COVID-19 vaccination. They continue to actively evaluate the safety of simultaneous administration of COVID-19 and influenza vaccines and the safety of COVID-19 vaccination in special populations, including pregnant women.

Systems-Level Analyses of Immune Responses to Vaccination

Thomas Hagen, PhD, was co-first author on a publication describing the first systems-level analysis of immune responses to the Pfizer-BioNTech COVID-19 mRNA vaccine that demonstrated mRNA vaccination primes the immune system to induce a broader and more robust innate immune response following booster immunization. Single-cell analysis identified a myeloid cell cluster expressing heightened antiviral and interferon-response pathways that emerged uniquely following the boost dose furthering the understanding of vaccine responses.