Tristen Sweeten, a 34-year-old nurse in Utah, hopes her three children will receive the Modern COVID-19 (MRNA.O) vaccine through her pediatric clinical trial. The sooner the better, he said, for his safety and the bigger goal of ending the pandemic.
Angie Ankoma, a 45-year-old black mother of four who works in philanthropy in Rhode Island, believes the trials should include several populations and that she herself participated in a vaccine against COVID-19. Volunteering her children for a possible inclusion in Moderna’s trial was a tougher call.
Sweeten and Ankoma are among thousands of American parents who volunteered to have their children participate in new trials led by Pfizer (PFE.N) with BioNTech or Moderna, the first companies to move forward with the development of a COVID-19 vaccine safe for the country’s 48 million. children under 12 years.
Health officials say vaccines are crucial to ending the pandemic. But many are concerned that the vaccination of the vaccine in some adults is even more pronounced with regard to their children. Parents may question the risks and benefits, given the unknowns about the long-term impact of vaccines on children’s development and data on how few young children have been affected by COVID-19.
To alleviate these concerns, some scientists claim that the U.S. Food and Drug Administration should slow down the review process of pediatric COVID-19 vaccines.
Pfizer spokeswoman Jerica Pitts said it was premature to speculate on a pathway of approval for children, but the company plans to work with public health institutions to promote the importance of vaccines.
Modern research scientist Dr. Jacqueline Miller said the company has spoken to the FDA about how best to eliminate the vaccine for use in children. He said the company expects the vaccine to be available to children through the U.S. Emergency Use Authorization that got it to U.S. adults in record time, in part to enable children to return to the U.S. school “and the things everyone wants to be doing.”
Sweeten’s husband, Scott, is a clinical researcher whose company has worked on the Johnson & Johnson (JNJ.N) and AstraZeneca (AZN.L) adult vaccine trials, so the couple, with children 5, 8 and 10 year olds, feeling comfortable were developed, Tristen said.
“We think they are very safe,” he said.
Ankoma consulted his pediatrician giving him doubts about long-term unknown effects. Finally, she decided it was worth the risk of immunizing her four children, ages 7 to 16.
“It was easier to decide for myself than for the kids, because … it was my own body,” he said.
“THAT MOMENT OF GOLDILOCKS”
Researchers leading pediatric trials for Moderna and Pfizer in children up to 6 months are confident that vaccines will be as safe and effective for children as they have been for adults.
The Pfizer vaccine, which is now available to people 16 years of age or older in most U.S. states, has been shown to work well in children ages 12 to 15 and may receive regulatory approval for this group. age as early as next month.
Moderna and Pfizer have said vaccines could be widely available for even younger children in early 2022.
An April 2-5 Axios / Ipsos survey found that only 52% of U.S. parents said their children are likely to be vaccinated as soon as they are eligible.
Children under the age of 12 have so far had a relatively low risk of coronavirus.
However, some 284 children have died from COVID-19 since last May, about 0.06% of all deaths from COVID-19, according to data from the American Academy of Pediatrics from nearly 43 states. There were 14,500 hospitalizations among children from 24 states during this 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 reaction or lasting symptoms known as long-term COVID.
“It is certainly not correct to say that it is benign in children. Anyone who works in a children’s hospital can tell you how many sick children we have cared for, ”he said.
Children already receive vaccines against diseases that have similar or lower related mortality levels in children, such as hepatitis A, chickenpox, rubella, and rotavirus.
Health officials warn that if they are not vaccinated, children could be a reservoir for infection, allowing virus variants to circulate and grow that can bypass vaccines.
That these vaccines have been widely used in adults before making them available to children should reassure parents, said Emmanuel Walter, head of Pfizer’s pediatric vaccine test at Duke University.
Some other vaccines have been developed and given only to children, such as the chickenpox vaccine.
More than 63 million Americans have received the Pfizer vaccine and about 55 million shot Modern.
Trials for young children are more involved than for adolescents, as they begin by testing very small doses and gradually increase the dose while controlling for side effects.
“What we’re trying to find is that Goldilocks moment when we have enough vaccine to generate a very good immune response, but we don’t have so many that we’re causing a lot of fever and pain in the arms and anguish baby or the youngest child,” he said. say Buddy Creech, a professor at Vanderbilt University who works in the pediatric trial of Moderna.
Some scientists said waiting for standard approval instead of looking for a U.S. would add months to the calendar, but would allow more security data to be gathered that could help increase public confidence.
The FDA declined to comment.
Dr Cody Meissner, head of pediatric infectious diseases at Tufts University School of Medicine, said it was a question: “Does a low safety assessment justify a low safety assessment in children? “
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