CLOSE

Brothers, four and nine years old participate in a Covid vaccine clinical trial NorthJersey.com

LINKEDINCOMMENTMORE

One participant is a 10-year-old girl who witnessed her parents’ relief when they received COVID vaccines after working throughout the pandemic at a Bergen County hospital as front-line physicians.  

Another is an 8-year-old boy who wants to be a doctor like his father, a pediatric emergency physician in Middlesex County. He didn’t flinch when the nurse gave him his jab. Neither did his 4-year-old brother, who wants to do whatever his older sibling does.  

The three are among scores of children who, with the consent of their parents, are participating in a clinical trial at Rutgers University on the safety and effectiveness of the Pfizer-BioNTech COVID vaccine in children. The participants, from all over New Jersey and parts of New York and Pennsylvania, range in age from 6 months to 11 years.  

With schools set to reopen for in-person classroom instruction in September and the highly transmissible delta variant of SARS-CoVid-2 now dominant across the country, vaccination of children will be crucial to preventing future waves of the pandemic, experts say. It is anticipated to benefit not only those who receive the vaccine, but the public at large.  

“Vaccination of young people protects individuals, protects families, and protects communities,” Rochelle Walensky, director of the federal Centers for Disease Control and Prevention, said this month. “With the delta variant circulating more now, widespread vaccination remains even more critical.”  

The delta variant has already fueled a summer surge of the virus, with new daily cases nearly tripling — from 13,747 to 39,719 on Sunday  — over the last month in the United States, reversing weeks of decline. While that is small compared to winter’s peak of new cases, the continuing spread multiplies opportunities for new, perhaps more dangerous, variants to emerge. Another surge is predicted in the fall, when kids go back to school and activities move indoors.  

Authorization to use the Pfizer vaccine for 5- to 11-year-olds is expected between September and December, said David Kessler, chief scientific officer for the COVID-19 response at the federal Department of Health and Human Services and former director of the federal Food and Drug Administration.  

The government has already begun procuring supplies of the Pfizer vaccine and another produced by Moderna to be ready, if the decision is made to use it in children under 12 in the fall or winter, he said. “The cupboard is full.”  

Vaccinated yet vulnerable: Rare breakthrough COVID case takes NJ transplant recipient's life

COVID presents real risks for kids

While children generally develop milder cases of COVID-19 than adults and are rarely hospitalized for severe illness, the risks they face from the disease are real — exceeding those from other communicable diseases, such as flu, for which vaccines are already required. 

As in adults, COVID can be more severe for kids with underlying conditions such as asthma, diabetes or obesity. Some children develop a potentially lethal inflammatory syndrome weeks after the infection, even if they didn’t initially have symptoms. They also are at risk for “long COVID,” which can affect thinking and stamina, among other consequences, for months.  

And they can spread it to others, even when they have no symptoms.  

More than 4 million children in the United States have tested positive for COVID-19 since the pandemic began, and 397 have died. That is more than three times the number of children who died from influenza in the 2019-2020 flu season and more than died from swine flu in 2009-2010.  

Among those affected were 110,814 children in New Jersey who tested positive for COVID-19, 130 who developed multisystem inflammatory syndrome in children, or MIS-C, and seven who died of COVID.   

Dr. Simon Li, a pediatric intensive care physician and the principal investigator at the Rutgers site for the Pfizer vaccine clinical trial in children said he finds the public underestimates or downplays the effects of COVID-19 in children. “The patients we see with MIS-C, and those we see die with primary COVID — it's not small,” he said. 

“If anyone cares about the life of a child, it counts.”  

'A no-brainer'

That was part of what motivated Dr. Minh-Tu Do, whose sons Justin, 9, and Joey, 4, became part of the clinical trial at Rutgers.  

Do, an assistant professor of pediatrics at Rutgers Robert Wood Johnson Medical School, treated children with COVID “on a daily basis,” he said.  After seeing children admitted to the hospital with multisystem inflammatory syndrome and some patients who needed help to breathe, relying on supplemental oxygen or ventilators, he thought that getting a vaccine for his kids “was a no-brainer,” he said. 

“I’m a big proponent of them getting the flu vaccine, in the first place,” he said. He acknowledged each parent’s right to decide what’s best for their child, but said he understands the science of vaccine development and wants the protection of immunization for his children.  

His son, Justin, was eager, too. A rising fourth grader who plays soccer and likes video games, he followed the news about COVID and was well aware when his parents were vaccinated. After 16 months staying home and learning via remote instruction, the whole family has felt antsy to get back to normal activities.    

On June 10, the day of Justin's first shot, the researchers explained the risks and benefits, took a medical history, and did a physical exam. They swabbed his nose to test for COVID and took a blood sample. 

They asked not only for Do’s consent, but for Justin’s — via his signature on an iPad — to be sure he understood what the study was about and was willing to join it.  

Do had already explained that two out of three participants in the trial would get the actual vaccine while one out of three would get a placebo, a shot that looked like a vaccine but was really salty water. Neither Justin, his dad, nor the researchers would be told which he received.  

The injection Justin received contained 10 micrograms of material —  a third of the dose an adult would receive. A few days later, when 4-year-old Joey bared his arm for his shot, he received 3 micrograms —  a tenth of an adult dose.  

Justin said he felt a bit dizzy after the first shot and had a headache after the second. His father said he hopes that means he got the vaccine.   

Joey, who received his second shot last week, showed no lingering effects the following day as he played with Duplos in the living room of the family home and asked exuberant questions while his father read to him from the Nickelodeon’s Paw Patrol collection of five-minute stories. That led Do to suspect that Joey received a placebo or the dose was so small it caused no side effects. 

App: Is NJ vaccine app for COVID records really a passport?

The real thing or placebo? 

Another Rutgers participant also believes she received a placebo.  

The 10-year-old daughter of two Bergen County physicians, Maya became the sole unvaccinated member of her family after her two older brothers got the shots in the spring. (Her mother asked that her last name not be used.) She, too, wanted to be immunized.  

When Nisha Gandhi, her mother, told her about the clinical trials for kids her age, Maya asked to join one. Her mother first found a study in Idaho that would accept her daughter. When the Rutgers site offered her a spot, Gandhi was delighted to make the trip to New Brunswick instead.   

Like Justin, Maya was asked to indicate that she understood the study and wanted to participate, with a signature on an iPad. Maya chose her arm for the injection site — “because I had a softball game afterward” — and the design on her Band-Aid. Her arm felt sore the next day, but that passed, she said.  

The second shot, earlier this month, left her feeling “a little off” for half a day, but she quickly recovered. Knowing that other members of the family had experienced stronger reactions, she concluded she received the placebo.   

The kids will be part of the study for 26 months. After six months, they and their families will learn whether they received the placebo or the vaccine, and those who received the placebo will be offered the real thing. 

Li, the principal investigator of the Rutgers trial, said so many families wanted to enroll their children that the study could have been filled five times over. Applicants were selected to mirror the ethnic and racial makeup of the region. Doctors’ kids were not given preference, he said.  

Rutgers is one of 90 Pfizer trial sites worldwide that are expected to enroll a total of 4,500 pediatric participants. Others are located in Spain, Poland and Finland.  

Moderna, makers of a COVID vaccine based on the same technology using messenger RNA to provoke an immune response, applied in June for authorization to extend its use to teens between 12 and 18 years old. It’s conducting separate clinical trials, planned to include 7,000 children, on smaller doses of its vaccine in younger age groups.  

Johnson & Johnson, maker of the single-shot vaccine approved for adults in the United States, is currently enrolling a small number of 16- and 17-year-olds in clinical trials in Spain and the United Kingdom, the company said in April. 

Weighing risk against benefit

When decision time comes for the federal Food and Drug Administration, the risks of the vaccine will be weighed against the benefits of preventing COVID in the age group for which the authorization is sought.  

That risk-benefit balance is different for children than adults, because children have lower odds of severe illness or death from COVID. In other words, a higher level of risk from the vaccine is acceptable for adults because they are more likely to face severe illness or death if they get infected.  

Balancing that is the risk of harm from the vaccine itself. The clinical trials are limited in size and duration, however. Rare side effects that turn up when a vaccine is given to millions of people may not appear or be seen as statistically significant in a relatively small study sample.  

And the application for emergency use authorization also is likely to be considered before safety data from a full six months post-vaccine are gathered for the 5- to 11-year-olds in the study.   

Countering those doubts, experts offer two arguments. First, they note that the vaccine has already been used in millions of adults. Second, they point to the strong monitoring system in place to detect any problems that crop up after vaccines are put into widespread use.  

“There are very few vaccines put into our children that have been used in so many adults prior to going into kids, and for which the safety profile is so well known,” said Dr. Kawsar Talaat, an associate professor at Johns Hopkins Bloomberg School of Public Health.  

The vaccines authorized for use by the FDA already have been given to more than 175 million adults in the United States. Another 9.6 million teenagers between 12 and 18 years old have received at least one dose of the Pfizer vaccine, the only shot currently authorized for those younger than 18.  

And so far, the federal Centers for Disease Control and Prevention has confirmed relatively few adverse events. They are so rare, the agency has concluded, that its recommendation for vaccinating everyone age 12 and older stands.  

The agency notified physicians about the following, after evaluation by its Advisory Committee on Immunization Practices:  

  • Blood clots combined with a low blood platelet count among some young women who received the Johnson & Johnson vaccine. Among 12.8 million doses given, 38 confirmed reports of this disorder were found, according to the CDC.
  • Inflammation of the heart muscle (myocarditis) or heart lining (pericarditis), among people under age 30, mostly men, who received the Pfizer or Moderna mRNA vaccines. The investigation is continuing; 633 cases have been confirmed among 1,047 reported. Hundreds of millions of doses of the mRNA vaccines have been given so far, and the CDC notes that the risk of myocarditis from COVID itself is higher.  
  • Guillain-Barre syndrome, an immune disorder that affects the nerves and causes muscle weakness or paralysis, is being investigated after about 100 reports were received about recipients of the Johnson & Johnson vaccine, mostly in men over age 50. Again, that is among 12.8 million doses given. 

This is the third time Rutgers has served as a COVID-19 vaccine clinical trial site for pharmaceutical companies. Last fall, it conducted trials for the Moderna and Johnson & Johnson vaccines. 

The studies in children receive the same rigor and attention to safety as those for adults, said Peter Marks, director of the Center for Biologics Evaluation and Research at the Food & Drug Administration. 

The goal is transparency, he said, to enable the safe expansion of vaccination so that the COVID pandemic can be brought under control.  

Lindy Washburn is a senior health care reporter for NorthJersey.com. To keep up-to-date about how changes in the medical world affect the health of you and your family, please subscribe or activate your digital account today.

Email: washburn@northjersey.com 

Twitter: @lindywa 

LINKEDINCOMMENTMORE
Read or Share this story: https://www.northjersey.com/story/news/coronavirus/2021/07/19/when-will-covid-vaccine-shots-ready-for-under-12/7926323002/