Rutgers has been selected as the clinical trial site for the global Pfizer-BioNTech research study to evaluate the efficacy of the COVID-19 vaccine in children 6 months to 11 years of age.
This is the third time Rutgers has served as a clinical trial site for COVID-19 vaccines for pharmaceutical companies. Last fall, it conducted trials for Moderna and Johnson & Johnson.
The Pediatric Clinical Research Center at Rutgers Robert Wood Johnson Medical School in New Brunswick is one of several clinical trial sites for the Pfizer-BioNTech pediatric study. It is the only clinical trial site in New Jersey. Rutgers will enroll up to 100 children aged 5 to 12 and 50 children aged 2 to 5 years and 6 months to 2 years each of the 4,644 children who will be enrolled worldwide.
Participants who meet the eligibility requirements for the study will be randomly selected to receive two doses of the potential vaccine or a placebo. Participants are unblinded six months after the second dose and the vaccine is offered to those who received the placebo.
Researchers will find out whether those vaccinated have lower rates of infection with moderate to severe symptoms than those who have not been vaccinated for two years.
“Children can get sick from COVID-19 and can spread the virus to others, even if they are asymptomatic. While most children experience mild or no symptoms, some children can become seriously ill and have long-lasting effects,” said co-lead. researcher Simon Li, associate professor of pediatrics at Rutgers Robert Wood Johnson Medical School. “Maximizing COVID-19 vaccination across all age groups is important to halt the global progression of the disease. Vaccination will also help us feel safer when our children return to school and resume their daily activities.”
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