Why one Montclair family wanted to be part of child vaccine study
By JAIMIE JULIA WINTERS
When Montclair parents and physicians Rachel Rosenberg and Khalil Savary heard that they had a shot at getting their children, 6 and 3 years old, vaccinated through a vaccine trial at Rutgers in New Brunswick, they jumped at the chance.
“We were really excited at the possibility of getting them vaccinated as soon as possible and to be part of the science,” said Rosenberg, who works in family medicine. Her husband is a pediatric lung doctor.
Children ages 5 to 11 could soon be the next group to be offered a COVID-19 vaccine.
Clinical trials were undertaken in the summer with children between the ages of 6 months and 11 years with the Pfizer-BioNTech COVID-19 vaccine, now marketed as Comirnaty. On Sept. 20, Pfizer-BioNTech reported ”favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age,” according to a press release.
Whereas children under age 18 made up 16.3% of all COVID-19 cases throughout the U.S. as of Oct. 7, according to the American Academy of Pediatrics, more children are now getting the virus. From Sept. 30 to Oct. 7, children represented 24.8% of the cases, which reflects a 6% rise, according to the academy.
“Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine. We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children,” said Albert Bourla, chairman and chief executive officer of Pfizer.
“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. — underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”
Although the symptoms of COVID-19 in young children have been reported as mild, some have reported more serious conditions, especially with the Delta Variant.
In New Jersey, 13.2% of all cases are now children under age 18, with 1.6% being hospitalized.
“My job as a parent is to keep them as healthy as possible. What if they wind up in the hospital or have long-term issues due to the virus?” Rosenberg said.
Then there’s herd immunity: in 2020, 18.37 percent of the U.S. population fell into the 0-14 year category, according to the census.
The study was so popular that their daughter didn’t make it into the first round, but made it into the second round in August, Rosenberg said. Her son received both of his shots in July. Her daughter received hers in August and September.
"She is proud to be one of the first kids to have gotten the vaccine," Rosenberg said, adding that her daughter is eagerly awaiting to find out if it was the real or "fake" one.
Since the blind study required that two-thirds of the participants get a real vaccine and one-third receive a placebo, the family won’t know until either the vaccine gets approval for their age group or six months after their second dose.
According to Rutgers, the testing was broken down into three age groups: children ages 5-11, 2-5 and 6 months-2 years. The study evaluated the “safety, tolerability and immunogenicity” of the Pfizer-BioNTech COVID-19 vaccine on a two-dose schedule (approximately 21 days apart) on the three age groups, which were given smaller doses, one-third for the 5-11 age group and smaller for the under-5 groups.
Rosenberg said that her children experienced no side effects besides a little soreness at the injection site.
The Pfizer COVID-19 vaccine is currently approved for individuals 12 years of age and older.
On Oct. 26, the FDA is expected to meet to consider the vaccine for ages 5 to 11. The final say will come through the Centers for Disease Control and Prevention, which is expected to consider it in early November.
“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against COVID19,” Pfizer tweeted on Oct. 7.
According to a recent study released in June by the Kaiser Family Foundation, vaccination rates continue to increase among children ages 12-17. One-third of parents of children in this age range reported their child has received at least one vaccine dose, up from 24% in May. However, one-quarter say they will “definitely not” vaccinate their child. The participants were split on whether schools should require COVID-19 vaccination.