Tristen Sweeten, a 34-year-old nurse from Utah, hopes her three children will receive the Moderna (MRNA.O) COVID-19 vaccine 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 who works in philanthropy in Rhode Island, believes the studies should include diverse populations and participated in one for the COVID-19 vaccine. Her children’s volunteering for a possible inclusion in Moderna’s trial was a tougher call.
Sweeten and Ankoma are among thousands of parents in the US who have volunteered to have their children participate in new studies led by Pfizer (PFE.N) with BioNTech or Moderna, the first companies to make progress in developing a COVID-19 vaccine. safe for 48 million countries. children under 12 years.
Health officials say vaccines are crucial to ending the pandemic. But many are worried that the holiday in some adults will be even more pronounced when it comes to their children. Parents may question the risks to benefits, given the unknowns about the long-term impact of vaccines on children’s development and data on how few young children have been severely affected by COVID-19.
To alleviate these concerns, some scientists say the US Food and Drug Administration should slow down the review process for pediatric COVID-19 vaccines.
Pfizer spokeswoman Jerica Pitts said it was premature to speculate on a path of approval for children, but the company plans to work with public health institutions to promote the importance of vaccines.
Dr. Jacqueline Miller, a scientist in modern research, said the company talked to the FDA about the best way to eliminate the vaccine for use in children. She said the company hopes to make the vaccine available to children through the Emergency Use Authorization (EUA), which brought it to American adults in record time, in part to bring children back to school “and the things they crave. all of you to do. “
Sweeten’s husband, Scott, is a clinical researcher whose company worked on the Johnson & Johnson (JNJ.N) and AstraZeneca (AZN.L) adult vaccine studies, so the couple, whose children are 5, 8 and 10 years, they feel comfortable with how they were developed, Tristen said.
“We feel very safe,” she said.
Ankoma consulted her pediatrician, given her overwhelming doubts about the unknown long-term effects. Finally, she decided that the risk was worth immunizing her four children, aged between 7 and 16.
“It was easier for me to decide for myself than for the children, because … it was my own body,” she said.
“THAT MOMENT OF GOLDILOCKS”
Researchers conducting pediatric clinical trials for Moderna and Pfizer in children up to 6 months of age are confident that vaccines will be as safe and effective for children as they were for adults.
The Pfizer vaccine, already available for people 16 years of age and older in most US states, has been shown to work well in children between the ages of 12 and 15 and may receive regulatory approval for that age group immediately after the month. future.
Moderna and Pfizer said vaccines could be widely available even to younger children by early 2022.
An April 2-5 Axios / Ipsos survey found that only 52% of US parents said they would be likely to vaccinate their children as soon as they became eligible.
Children under the age of 12 have so far had a relatively low risk of coronavirus.
However, about 284 children have died from COVID-19 since May last year, about 0.06% of all COVID-19 deaths, according to data from the American Academy of Pediatrics in about 43 states. There were 14,500 hospitalizations among children in 24 states during this time, about 2% of the total.
Dr. Sean O’Leary, a professor of pediatrics at the University of Colorado, said the vaccination will help children avoid hospitalizations, a rare inflammatory reaction or long-lasting symptoms known as long-term COVID.
“It is certainly not fair to say that it is benign in children. Anyone who has worked in a children’s hospital can tell you how many sick children I have cared for, ”he said.
Children already receive vaccines for diseases that have similar or lower levels of associated mortality in children, such as hepatitis A, chickenpox, rubella and rotavirus.
Health officials warn that if left unvaccinated, children could be a reservoir for infection, allowing the circulation and growth of virus variants that can steal vaccines.
The fact that these vaccines will be widely used in adults before they are made available to children should reassure parents, said Emmanuel Walter, head of the Pfizer pediatric vaccine study at Duke University.
Some other vaccines have been developed and given only to children, such as shot chicken pox.
More than 63 million Americans received the Pfizer vaccine and about 55 million were shot with Moderna.
Studies in young children are more involved than in adolescents, as they start by testing very low doses and gradually increase the dose while monitoring for side effects.
“What we’re trying to find is that Goldilocks time when we only have enough vaccine to generate a very good immune response, but we don’t have enough to cause a lot of fever, arm pain and suffering in the baby or toddler,” said Buddy Creech, a professor at Vanderbilt University who works in the pediatric study of Modern.
Some scientists have said that waiting for standard approval instead of looking for an EUA will add months to the calendar, but would allow the collection of more safety data that could help increase public confidence.
The FDA declined to comment.
Dr. Cody Meissner, head of pediatric infectious diseases at Tufts University Medical School, said it boils down to a question: “Does the low burden of disease in children justify a longer safety assessment?”
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