Covid-19 vaccine trials: Why these parents volunteered for their young children

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Now, toddlers and babies under 6 months of age are testing Covid-19 vaccines to help make sure they’re safe for other young children. If pediatric trials go well, children under 12 may be eligible for the fall or winter vaccination.

For many parents, the decision to volunteer for their children was an easy one.

A family knows the suffering of suddenly losing a healthy child to an unexpected illness and does not want any other family to bear the same.

And one family is so excited to help protect the kids, they’ve enrolled the three babies – aged 6, 3 and 14 months – into a Covid-19 vaccine trial.

Here’s what parents who have applied to volunteer for their children want other families to know:

“You don’t want that statistic to be”

Rebecca and Michael Calloway never imagined that they would lose their energetic, young child to an unexpected illness.

Shortly after Thanksgiving, 3-year-old Alice fell seriously ill and was hospitalized with swelling in her brain. She died a few days later.

“It turns out she had type 1 diabetes,” Rebecca Calloway said. The US Centers for Disease Control and Prevention says that type 1 diabetes cannot be prevented.

“We lost our daughter to something we can’t control,” Calloway said.

But Covid-19 is “something we can control. (Vaccines) have been shown to work for millions of Americans.”

“We can be a part of showing people that this is safe, yes, this is safe,” said the mom from rural Maryland.

“This will keep your children safe. It will keep (those) who cannot be vaccinated safe. We want to be a part of that.”

So her 7-year-old daughter Georgia is testing the Moderna Covid-19 vaccine.

Their youngest child, 2-year-old Lochlan, is already a veteran of the vaccine trial. When he was two months old, he began participating in the meningitis vaccine trial.

“They want to work on improving it for younger children because meningitis is something that young children still get and die from,” Calloway said.

While childhood deaths from meningitis, type 1 diabetes and Covid-19 are rare, they do happen. When it happens to your family, Calloway said, the sadness is overwhelming.

“You don’t want that statistic to be,” she said. “I would never want someone to go through the pain of losing a child. It’s devastating beyond anything you can imagine.”

Even before Ailish’s death, Calloways planned to support vaccine trials because their relatives had suffered the consequences of not being vaccinated in the past.

“My family and my husband’s family have a history with the fallout from not getting vaccinated,” Calloway said.

Michael’s aunt died of diphtheria. His father nearly died of whooping cough. Rebecca’s grandmother contracted polio and contracted rubella while pregnant with Uncle Rebecca, who was born completely deaf and had brain and heart problems.

“We’ve seen the effects of what would happen without vaccines,” said Rebecca Calloway. “These are very real for us in our family.”

Even at the age of three, Alice was also passionate about helping others. She started telling everyone that she wanted to be a doctor.

Calloway said Ailish would have been very proud of her sister Georgia for testing the Covid-19 vaccine.

“Georgia was her hero,” their mother said.

Without vaccinating children, it would be impossible to obtain herd immunity

Dr. C.J. Boye is a pediatric neurosurgeon. But when Covid-19 began to overwhelm hospitals, he and other doctors from various specialties volunteered to help treat Covid-19 patients.

“Seeing how harmful adults, (even) young adults can be,” said the Louisiana doctor, “was worrisome.” “I saw a healthy 30-year-old die a miserable death.”

Now, with more problematic variants spreading among unvaccinated people, Bowie and his wife have enrolled their three children in a trial of the Pfizer Covid-19 vaccine.

“We have seen how terribly Covid has affected patients,” said Bowie’s wife, neurosurgeon Dr. Irene Bero. “We felt very strongly involved in the research – obviously for the opportunity to vaccinate our children (and) to continue to push the needle forward in the fight against Covid.”

Their 6-year-old daughter Ellie got her first injection on June 8. Her younger brother Christian, 3, and baby sister Sloan, 14 months, received their first injections on June 21.

This phase 2/3 of the Pfizer study is double-blind, so the family does not know whether each child received a dose of the Covid-19 vaccine or a placebo. Six months after the second injection, the study will be “unblinded,” and those who got a placebo will be able to get the real vaccine.

Their parents said that none of Bowie’s three children had any side effects after the injection.

Before volunteering for their children, Bowie and Bero weighed the risks and benefits — from both the doctors and parents’ perspectives.

“If you really look at the data, the risk is significantly lower with this vaccine than with many common medications. So that played a role,” Bowie said.

Another reason is the need to suppress the coronavirus before it turns into more dangerous variants or those that could avoid vaccine protection. Without mass vaccination of children, Bowie said, “it would really be impossible to reach herd immunity” – the point at which enough people are protected against the virus to suppress its spread.

As more variants develop and spread among unvaccinated people, the barrier to accessing herd immunity may become higher.

“There is potentially one alternative away from removing all this progress,” he said.

Bowie is also concerned about MIS-C, or pediatric multisystem inflammatory syndrome – a rare but serious condition that can occur in children weeks after infection with the coronavirus.

The doctors also share a desire expressed by many parents: They want children to learn in classrooms “full-time” and to return to school safely, Biro said.

“And safety for us means vaccination.”

How the Covid-19 pediatric vaccine trials work

The only Covid-19 vaccine available to minors in the United States is the Pfizer vaccine, which is allowed for ages 12 and older. (Moderna requires its vaccine to be licensed for ages 12 to 17.)

Pfizer and Moderna have both begun trials of a Covid-19 vaccine on children aged 6 months to 11 years.

In the first part of Moderna’s Phase 2/3 pediatric trial, all participants are vaccinated at different levels, without any placebo. Families know what dose their children are getting, with children ages 2-11 given one of two possible dose levels – 50 mcg or 100 mcg per dose. (The dose for each person is 100 mcg.) Participants aged 6 months to 2 years may receive one of three dose levels—25, 50, or 100 mcg. “An interim analysis will be done to determine which dose will be used in Part 2, the expansive placebo-controlled part of the study,” Moderna said.

Some may be surprised that children can test adult doses. Pediatrician Dr. James Campbell, principal investigator of the University of Maryland Children’s Vaccine Study at the University of Maryland School of Medicine, said parents don’t need to worry about a so-called overdose.

“These are very, very small amounts,” he told CNN. “So when you’re talking about half or double a very small amount, it’s still a very small amount. You can’t overdose on the doses of the vaccine.”

What may happen is that higher doses may lead to more side effects. That’s what investigators are trying to determine, Campbell said.

“Can 100 micrograms cause 10% of people to have a fever, and 50 micrograms cause 5% to have a fever? … That’s what we’re looking for,” he said.

Scientists are trying to figure out what doses best combine high efficacy and minimal side effects.

Of course, 6-month-olds cannot describe any side effects they may have. So how do parents know if their young child is experiencing side effects?

“It’s like any other child who gets sick — they get upset,” said Dr. Julia Garcia Diaz, principal investigator of the pediatric vaccine study at Ochsner Children’s Hospital in New Orleans.

“They don’t eat the same, or they just get upset and cry. Parents are attuned to their children’s behavior,” she told CNN.

Dr. Ashish Jha, dean of Brown University’s School of Public Health, told CNN in April that any adverse side effects from vaccines “emerge within the first two weeks and certainly in the first two months” after vaccination.

Garcia Diaz agreed to this time frame.

“After that, your body has made the antibodies. It has done what it is supposed to do,” she said. “So most likely the things outside that window are not relevant.”

Campbell and Garcia Diaz said that while some families were reluctant to vaccinate their children, many were eager to participate in vaccine trials.

“There has been a huge amount of interest,” said Garcia Diaz, director of clinical infectious disease research at Ochsner Health.

“Parents have been calling us for weeks on end trying to find out when the trial would start.”

Pfizer’s trial for young children began in March and is expected to request an emergency use authorization from the U.S. Food and Drug Administration for ages 2 to 11 in September, the company said.

Moderna said that if trials go well, its vaccine could be available for children under 12 this winter or early 2022.

A nine-year-old feels like he’s helping to save the world

Dr Charles Mugera saw patients deteriorating rapidly with Covid-19.

“I was checking in patients every day, sending them to the ICU — some dying on the floor,” said Mugera, an internist in Maryland. “Going to work every day was scary, not just for what would happen to patients but to what would happen to us,” health care workers.

“This vaccine has completely changed the game.”

He’s been watching the data and knows as vaccinations go up, the Covid-19 numbers go down. “Not only have we seen deaths, hospitalizations and infections go down, but the possibility of transmission has gone down because we got a vaccine that doesn’t transmit the disease,” Mugera said.

“So it is quite clear that in order to end this epidemic, we have to not only protect ourselves from severe disease, but[also]vaccinate children. Because even though children have not been seen to be at risk of death and severe disease, they pass it on.”

His wife, Dr Kabuya Ruth Mugera, is a pediatrician who also believes children need to be vaccinated against Covid-19.

So they asked their two sons — Gerald, 11, and Christian, 9 — if they would take part in the Moderna vaccine trial.

“Educate them and get them involved—yes, that required a bit of persuasion,” Mugera said, especially given the fear of needles.

Mugera said their mother “explained how it works, what it does, how it protects you, and how to get your life back. You can travel. Go back to birthday parties. Go back to school (in person).”

“It crystallized in their mind very quickly that this is the way to normalcy.”

But because the experiment required blood to be drawn to monitor for antibodies, and Gerald had difficulty drawing blood, only Christian was selected for the experiment.

The 9-year-old received two doses of Moderna vaccine – the full adult dose each time.

Christian had arm pain after his first dose, fever, muscle aches, and lethargy after his second dose. But after 24 hours, he was fine.

Mujira admits the family has been on high alert for anything that might resemble harmful side effects. He got nervous when Christian got a rash.

“At first we were like, ‘Oh my God, is this something from the vaccine?'” He said.

But Gerald – who was not vaccinated – later developed the same rash. It turned out to be contact dermatitis after the boys played outside and climbed a tree.

Gerald recently turned 12 and was able to get the Pfizer vaccine. Now the whole family is looking forward to a vacation abroad.

Mujira said that although Christian was initially reluctant to receive a vaccination, he is now excited to play with friends without masks and return to his normal childhood without worries.

He is also proud to help other children by testing the vaccine for them. Christian’s father said that his youngest son had developed a new spell:

“We will save the world. We will change the world.”

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