Pfizer Awaits COVID Childhood Vaccine Results At Rutgers Site

NEW BRUNSWICK, NJ — It is extremely unlikely a coronavirus vaccine for children will be approved in time for kids headed back to school in September.

Pfizer is still collecting clinical data from its coronavirus vaccine trials in children, part of which is taking place at the Rutgers' New Brunswick campus.

Rutgers is one of 90 sites worldwide where Pfizer is testing its vaccine in children 12 and under. In total, the Pfizer trial will test approximately 4,644 children at trial sites in the United States, Finland, Poland and Spain, the pharmaceutical company said.

"If safety is confirmed, and pending authorization or approval from regulators, we hope to submit the vaccine for potential Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) sometime in the September-October time frame for children 5 to 11, and soon after for 6 months to 5," said Pfizer in its most recent statement about their childhood vaccine trials.

And the FDA has long said that it expects a vaccine for children to be approved on a “fall or winter timeline.”

Moderna is currently testing its coronavirus vaccine on 12,000 children across 100 sites in the U.S.

It was first announced in early May that Rutgers University was selected as a clinical trial site for Pfizer-BioNTech to test its vaccine in children.

200 children total are in the Pfizer trial at Rutgers: One group of 100 children ages 5-11, who were tested first, followed by another 100 children, 50 children ages 2 to 5, and 50 children 6 months to 2 years.

Dr. Minh-Tu Do, a pediatric ER doctor who lives in New Jersey, told NJ Spotlight why he decided to enroll his sons, ages 9 and 4, in the Rutgers trials earlier this summer:

“Knowing how devastating this disease can be, I also wanted to make sure our children were protected not only for themselves but also for others," he told NJ Spotlight. "I've seen a lot of patients who were diagnosed with COVID-19. I've seen the best and the worst. So knowing how devastating this disease can be, I wanted to make sure my children were protected, not only for themselves but also for others."

He said his 9-year-old son, Justin, has been asking his parents when he can get the vaccine. Dr. Do said he and his wife researched it and decided to enroll both children in the Pfizer trial.

Pfizer said once the vaccine is determined to be safe for children 6 months to 12 years old, they will then subsequently test it on infants and babies under 6 months.

Those 200 children in the Rutgers trial are randomly selected to receive two doses of either the vaccine or a placebo. Participants will be unblinded six months after the second dose and the vaccine will be offered to those who received the placebo.

Rutgers researchers will then track all the children for the next two years, looking to see if those who were vaccinated have lower rates of infection than those who got the placebo.

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