Rutgers Now Enrolling Children 6 Months And Up In Pfizer Trial

NEW BRUNSWICK, NJ — Rutgers University announced Friday it has been selected as a clinical trial site for the Pfizer-BioNTech vaccine to be tested in children.

The Food & Drug Administration is expected to greenlight the Pfizer vaccine for older kids, ages 12-15, any day now. What Rutgers is involved in is a third Pfizer coronavirus vaccine trial, where the shot is currently being tested in children six months to under 12 years old.

Rutgers will test 200 children total in its trial. There will be 100 children in the 5-11 group, which will be tested first, followed by 50 children ages 2 to 5, and 50 children 6 months to 2 years.

Rutgers is currently actively seeking New Jersey parents to enroll their children in the trial. Pediatricians and parents who are interested in their children being considered for the vaccine clinical trial can apply here.

In total, 4,644 children worldwide will be enrolled in the trials for the Pfizer vaccine worldwide.

If that number seems surprisingly low, Pfizer told Patch its initial adult vaccine study enrolled more than 44,000 people worldwide, and that that study gave them an indication of the vaccine's safety for teens.

"Our landmark study of our COVID-19 vaccine had more than 44,000 participants, and we have an understanding of safety and efficacy of the vaccine of 12-15 year-olds included in that study," said Jerica Pitts, director of global media relations for Pfizer. "We cannot speculate on a regulatory outcome, but we have a strong legacy is developing vaccines for pediatric populations."

Pfizer anticipates results from their childhood vaccine study to be available in the second half of 2021, the pharmaceutical company said this statement. Pfizer will seek emergency-use authorization for its early childhood vaccine (ages 2 to 11) in September, if not earlier.

Connecticut Gov. Ned Lamont said this week his state will most likely set up vaccine clinics at schools once the Pfizer vaccine is approved for teenagers.

The NJ Dept. of Health did not answer this week when Patch asked if New Jersey would do the same.

Pifzer, Moderna and Johnson & Johnson are all currently conducting trials on their coronavirus vaccine for children. While none of them have been approved by the FDA yet, Dr. Anthony Fauci said at the beginning of this week he expects the FDA to grant approval for the Pfizer vaccine for 12- to 15-year-olds "within several days."

No decision has been made by the FDA as of Friday.

In March, Pfizer tested its vaccine on 2,260 participants ages 12-15 and found "100% efficacy and robust antibody responses."

Similarly, Moderna said Friday, May 6 that an initial analysis of their TeenCOVE study of the vaccine in teens ages 12 to 17 showed vaccine efficacy of 96 percent and the vaccine was "generally well tolerated."

Currently, anyone 16 years and older is eligible to receive the Pfizer vaccine, and anyone 18 years and older is eligible for Moderna or Johnson & Johnson.

Children and coronavirus

Children do indeed contract coronavirus: More than 3.7 million children have been diagnosed with coronavirus during the pandemic, according to the American Academy of Pediatrics, which just released this major report on children and coronavirus on April 29.

However, children made up 0.00%-0.21% of all U.S. coronavirus deaths, according to that report.

In total, 573,000 Americans have died of coronavirus since the pandemic began.

However, the total number of children who died from coronavirus is difficult to obtain.

Harvard University says just over 400 of those deaths were under the age of 18. Other news sites have put that number at about 450.

"While most children experience mild or no symptoms, some children can get severely ill and could have long-term effects," said Dr. Simon Li, an associate professor of pediatrics at Rutgers Robert Wood Johnson Medical School, who is leading the Pfizer vaccine trial. “Children can get sick from COVID-19 and can spread the virus to others even if they are asymptomatic."

"Maximizing COVID-19 vaccination in all age groups is important to stop the global progression of the disease," Li added. "Vaccination will also help us feel safer about our children resuming school and daily activities.”

This is the third time Rutgers has served as a COVID-19 vaccine clinical trial site for pharmaceutical companies. Last fall, it conducted adults trials for the Moderna and Johnson & Johnson vaccines, and adults from across New Jersey participated. Rutgers students were also asked to participate.

The childhood trials will specifically be done at the Pediatric Clinical Research Center at Rutgers Robert Wood Johnson Medical School.

The status of all three vaccine trials for children:

Pfizer: Pfizer started clinical trials for its children's vaccine in March, on children six months to 11. In total, 4,644 children worldwide will be enrolled in the tests for the Pfizer vaccine worldwide, said Pfizer here.

The Rutgers site is the only clinical trial site in the state of New Jersey, however Pfizer is testing its kids' vaccine elsewhere in the U.S.

Here is how the Rutgers trial will work: 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 will be unblinded six months after the second dose and the vaccine will be offered to those who received the placebo. Researchers will track over the next two years whether those who were vaccinated have lower rates of infection with moderate to severe symptoms than those who were unvaccinated.

Moderna: Moderna announced March 16 in this company statement that it was starting clinical trials of its vaccine in children; its trials are called the KidCOVE and TeenCOVE study and they are testing the vaccine in children ages 6 months to 17 years.

Moderna said it intends to enroll approximately 6,750 pediatric participants in the U.S. and Canada. The company is currently experimenting with dose levels.

Both Pfizer and Moderna vaccines will require two shots for children, similar to adults.

Johnson & Johnson: New Brunswick-based Johnson & Johnson said in early April it was testing its vaccine on adolescents 12 to 17. It said the initial trial would be "a small number of adolescents" starting with ages 16-17 years, and then expanded to a larger group of younger teens.

The J&J trial started in Spain and the United Kingdom and then in the United States, the Netherlands and Canada, with Brazil and Argentina to follow.

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