Rutgers Yet Again An Under-5 COVID Vaccine Trial Site

NEW BRUNSWICK, NJ — Rutgers has again been selected as a clinical trial site for the global Pfizer-BioNTech research study for the bivalent COVID-19 vaccines in children under age 5.

This is the fourth time Rutgers has served as a COVID-19 vaccine clinical trial site for pharmaceutical companies. In 2021, it conducted trials for Moderna and Johnson & Johnson monovalent COVID vaccines, and in 2022, it conducted pediatric vaccine trials for the first Pfizer/BioNTech vaccine for children and babies.

Partnering with Pfizer/BioNTech, the Rutgers Rutgers Robert Wood Johnson Medical School will begin to study the bivalent vaccine in children less than 5 years old.

The Pediatric Clinical Research Center at Rutgers Robert Wood Johnson Medical School in New Brunswick is one of a few clinical trial sites for Pfizer-BioNTech’s pediatric study. It is the only clinical trial site in New Jersey.

The trial will include a substudy of children under 2 who have never received a COVID-19 vaccine and a substudy for children under 5 who have received doses of COVID vaccines.

Participants who meet the eligibility requirements for the study will be provided doses of the vaccine and will be required to have close follow up with the study team in New Brunswick where there will be clinical evaluation as well as blood tests. Intermittently there will be swabs performed to assess for infection with SARS Co-V 2 the virus that causes COVID-19.

“Children can get sick from COVID-19 and can spread the virus to others even if they are asymptomatic," said co-lead investigator Simon Li, an associate professor of pediatrics at Rutgers Robert Wood Johnson Medical School.

In the past two years, science has shown that anyone can get sick from coronavirus, even those who are vaccinated. The CDC has long said that the vaccines do not stop one from getting the virus, nor do they prevent transmission of the virus.

“While most children experience mild or no symptoms, some children can get severely ill and could have long-term effects,” said Li. "The vaccines thus far have proven to be quite safe as millions of doses have been given to children. Hopefully the bivalent vaccines will help us get ahead of and protect us from the viral mutations.”

For more information, see the Vaccine Study Referral Survey.