Tristen Sweeten, a 34-year-old nurse in Utah, hopes her three children will receive Moderna’s COVID-19 vaccine (MRNA.O) through her pediatric clinical trial. The sooner the better, she said, for their safety and the greater goal of ending the pandemic.
Angie Ankoma, a 45-year-old black mother of four who works in philanthropy in Rhode Island, believes trials should involve different populations and has herself participated in a COVID-19 vaccine. Volunteering her children for possible inclusion in the Moderna process was a more difficult call.
Sweeten and Ankoma are among the thousands of U.S. parents who have volunteered to have their children participate in new studies conducted by Pfizer (PFE.N) with BioNTech of Moderna, the first companies to make progress toward development of a safe COVID-19 vaccine for the country’s 48 million. children under 12 years old.
Health officials say vaccines are critical to ending the pandemic. But many are concerned that some adults’ hesitancy about vaccinations will be even more pronounced when it comes to their children. Parents may question the risks versus benefits, given the unknowns about the long-term impact of the vaccines on child development and data on the number of young children hard hit by COVID-19.
To address those concerns, some scientists say the U.S. Food and Drug Administration should slow down the review process for COVID-19 childhood vaccines.
Pfizer spokeswoman Jerica Pitts said it was premature to speculate on a pediatric approval route, but the company plans to partner with public health agencies to promote the importance of vaccines.
The modern researcher Dr. Jacqueline Miller said the company has spoken with the FDA about the best way to release the vaccine for use in children. She said the company hopes to make the vaccine available to children through an emergency permit (EUA) that it got from American adults in record time, in part to get kids back to school “ and the things they all yearn for. ” to do. “
Sweeten’s husband Scott is a clinical investigator whose company has been involved in the Johnson & Johnson (JNJ.N) and AstraZeneca (AZN.L) adult vaccine trials, so the couple, whose children are 5, 8, and 10 years old, are feeling on edge her ease with how they were developed, Tristen said.
“We feel they are very safe,” she said.
Ankoma consulted her pediatrician, given her nagging doubts about unknown long-term effects. She eventually decided that the risk was worth the risk of immunizing her four children, ages 7 to 16.
“It was easier for me to decide for myself than for the kids because… it was my own body,” she said.
‘THAT GOLDEN MOMENT’
Researchers leading pediatric studies for Moderna and Pfizer in children as young as 6 months old are confident that the vaccines will be just as safe and effective for children as they are for adults.
The Pfizer vaccine, which is already available to people 16 and older in most US states, has been shown to work well in children 12 to 15 years old and could receive regulatory approval for that age group as early as next month.
Moderna and Pfizer have said vaccines could be widely available to even younger children by early 2022.
An Axios / Ipsos poll from April 2-5 found that only 52% of American parents said they would likely get their children vaccinated as soon as they qualify.
Children under the age of 12 have a relatively low risk of the coronavirus so far.
Still, about 284 children have died of COVID-19 since May last year, about 0.06% of all COVID-19 deaths, according to data from the American Academy of Pediatrics from about 43 states. There were 14,500 hospital admissions to children in 24 states at the time, about 2% of the total.
Dr. Sean O’Leary, a professor of pediatrics at the University of Colorado, said vaccination will help children avoid hospitalizations, a rare inflammatory response, or persistent symptoms known as long COVID.
“It is certainly not correct to say that it is benign in children. Anyone who has worked in a children’s hospital can tell you how many sick children we have taken care of, ”he said.
Children are already receiving vaccines for diseases with similar or lower childhood mortality rates, such as hepatitis A, varicella, rubella and rotavirus.
Health officials warn that, if not vaccinated, children can be a reservoir for infection, allowing virus variants that vaccines can evade to circulate and grow.
That these vaccines will be widely used in adults before they are available to children should reassure parents, said Emmanuel Walter, chief of Pfizer’s pediatric vaccine research at Duke University.
Some other vaccines have been developed for and are only given to children, such as chicken pox.
More than 63 million Americans have received the Pfizer vaccine and about 55 million the Moderna injection.
The studies for young children are more involved than for adolescents because they start testing very small doses and gradually increase the dosage while monitoring for side effects.
“What we’re trying to find is that Goldilocks moment when we have just enough vaccine to generate a really good immune response, but we don’t have that much that we cause a lot of fever and arm pain and anxiety in the baby or in the younger child,” Said Buddy Creech, a professor at Vanderbilt University who is working on Moderna’s pediatric trial.
Some scientists said waiting for standard approval rather than seeking an EUA would add months to the timetable, but allow for more security data to be collected that could boost public confidence.
The FDA declined to comment.
Dr. Cody Meissner, chief of pediatric infectious disease at Tufts University Medical School, said it boiled down to one question: “Does the low burden of disease in children warrant a longer safety evaluation?”
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