By Elizabeth Chuck - NBC News
When Abhinav, a seventh grade student from Ohio, learned that a clinical trial of the coronavirus vaccine was accepting children near his city, he wanted to participate.
But there was one aspect of the study that had him concerned.
"Most of the time I was a little nervous about the blood draws, because I had one about five years ago and it was not very comfortable," said Abhinav, 12.
However, he decided to enroll in the trial, run by the pharmaceutical company Pfizer Inc.
"I think it could benefit the world and
help scientists learn more about the coronavirus,"
explained Abhinav, whose family asked that his last name not be used to protect their privacy.
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Abhinav received his first injection at Cincinnati Children's Hospital Medical Center last Thursday, becoming one of the youngest participants in the world to collaborate on a COVID-19 vaccine trial.
His father, Sharat, a specialist in bone marrow transplantation, had already participated in the trial and encouraged Abhinav to enroll after he experienced no severe symptoms, beyond a fever that lasted a day or two.
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"I am happy that he is doing his bit for science,"
Sharat said of her son.
"With the Pfizer study, no major side effects have been reported so far, so I also felt comfortable enrolling Abhinav," he added.
Earlier this month, Pfizer became the first pharmaceutical company in the United States to receive approval from the Food and Drug Administration (FDA) to test its vaccine in 12-year-old children.
Minors who signed up say they are safe and proud to participate.
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“They were talking about symptoms and it was just fatigue, low fever, headache.
And I was just thinking, 'I hope I don't have any of that because I don't want it to spread at school or work,' ”said Katelyn Evans, 16, of Green Township, Ohio.
"But I wasn't thinking about my long-term health because of a short-term inconvenience," he added.
Katelyn Evans, 16, receives a coronavirus vaccine during a clinical trial at Cincinnati Children's Hospital Medical Center on Oct. 14 Cincinnati Children's Hospital Medical Center
Like most other coronavirus vaccine trials, Pfizer's involves getting two injections.
Participants receive them three weeks apart, and then the researchers monitor their health for two years.
Participants do not know if they are receiving a placebo injection or a real prototype coronavirus vaccine.
Either way, the younger volunteers in the trial say they have confidence in the vaccines being developed, optimism that puts them at odds with many adults across the country.
Vaccines have sparked growing skepticism
due to the highly politicized terrain in which they have been developed and in just a matter of months, when it would normally take years or decades.
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A Stat News and Harris Poll poll conducted in October revealed that only 58% of Americans would be willing to receive a vaccine when it becomes available, compared to 69% of those surveyed in August.
But the researchers say the vaccines they are testing are safe.
"There is a perception that procedures are being skipped, but it is not true,"
said Dr. Robert Frenck, director of the Gamble Vaccine Research Center at Cincinnati Children's and principal investigator of the Pfizer trial.
"It's not that nobody is doing less, they are just compressing the process," he explained.
Pauses in other trials, including those by AstraZeneca and Johnson & Johnson, show that security protocols are followed closely, Frenck said.
Both AstraZeneca and Johnson & Johnson recently resumed their studies in the United States after suspending them to investigate the disease in one of the participants, something experts say is common in large-scale trials.
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Pfizer has not reported any unexpected illnesses among its participants and has communicated that it may be ready to request authorization for the emergency use of its vaccine by the end of November.
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For the study in Cincinnati, one of several sites where the company is involving children in the trials,
dozens of parents contacted by the researchers were eager to involve their children
, Frenck said.
"The parents asked how many times they would have to go and how many doses they would have to receive," he said.
"But no one has answered, 'Oh hell no,'" he added.
Why include children if they are less likely to get sick?
While the parents of the children in the trial are comfortable with the level of risk they take, others find it surprising that the children are being asked to sign up.
Bianca De La Cruz, 33, a professional with the New York City Department of Education, works with elementary school students and has a 13-year-old daughter.
She feels that Pfizer is using children as "guinea pigs."
"It is absurd," he said.
“We really don't even know much about the coronavirus to begin with.
So are we going to test a vaccine that they developed in six months?
It's crazy, "he said.
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Pfizer contends otherwise.
The decision to include children came only after the pharmaceutical giant first collected "satisfactory" safety and efficacy data on adults and older adolescents, said Jerica Pitts, Pfizer's director of global media relations.
In September, Pfizer expanded its study from 30,000 adults to approximately 44,000 people, which included adolescents up to 16 years of age and people with chronic diseases, such as HIV and hepatitis B and C. After receiving FDA approval for testing younger children and reviewing the data on those ages 16 and 17, Pfizer added children ages 12 to 15.
Opponents like De La Cruz still wonder why children should be part of the study.
In general, children do much better than adults when infected with coronavirus, and science has not yet fully clarified whether children, especially those under the age of 10, transmit the virus as easily as children. Adults.
However, the American Academy of Pediatrics believes that it is critical that children participate in vaccine trials.
On September 29, the agency wrote a letter to Secretary of Health and Human Services Alex Azar and FDA Commissioner Dr. Stephen Hahn, urging them to allow children to participate in the trials, noting that more than 587,000 cases of the coronavirus in children.
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"While the likelihood of spreading the disease can vary between different ages of minors, we know that they can transmit the virus at home, to their teachers and to other children," the letter said.
He added:
"Children should be included in vaccine trials to better understand any possible unique immune responses
and / or other unique safety issues."
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Dr. Yvonne
Bonnie
Maldonado, professor of pediatrics, epidemiology and population health at Stanford Medicine, is among those who support getting children involved in COVID-19 vaccine trials.
"Although the coronavirus does not appear to be targeting the pediatric age group, children are not immune to this disease," he said, noting that while children only account for about 10% of coronavirus cases in the US, and generally suffer mild symptoms, more than 100 children have died in this country from the virus.
And children may respond differently to vaccines than adults.
"Our forecast is that you would get the same kind of response in children," Frenck said.
"But we will know until we know that we are giving the right vaccine and the right dose at the right time."
"Pride" to contribute to medical research
So far, at Cincinnati Children's, there have been seven participants between the ages of 12 and 15 and 10 participants between the ages of 16 and 17, according to the hospital.
Katelyn, a 16-year-old from Ohio, did not have any side effects from the injection she received.
"It's not scary. There is nothing dangerous or intimidating," he said, adding that he hopes other young people his age will join the study.
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Katelyn's mother, Laurie Evans, an elementary school teacher, said that most friends and family supported Katelyn's decision to join, though some questioned whether it was safe to develop a vaccine at record speed.
"She has a big heart. She was obviously not afraid," Evans said. "I think
I'm more afraid of the coronavirus than the vaccine
.
"
Other parents whose children have participated in medical research say they feel the same way.
Heather Hannon, 48, an oncology nurse practitioner living in Chesterfield, Virginia, enrolled two of her children to participate in a late-stage vaccination trial for H1N1, or swine flu, during the 2009 pandemic. His sons, 16 and 14 now, were just 5 and 3 at the time, and Hannon used the opportunity as a teaching moment for them.
"It was emotion, it was pride, it was understanding that life is more than just you," Hannon said.
"I imagine a lot of parents would think I was pretty crazy," she added.
"But
in a clinical trial there are a lot of built-in safety mechanisms
and it's really exciting to participate in the research," he argued.
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Sharat, the father of Abhinav, 12, who is participating in the Cincinnati Children's coronavirus vaccine trial, hopes his son feels the same sense of helping others as Hannon's children.
"While most children will do well if infected, a small portion could become seriously ill," Sharat said.
“By being part of this study, we help others.
It is a small contribution, "he said.
