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Food and Drug Administration must work “aggressively” to authorize a Covid-19 vaccine for children under 12, wrote the director of the American Academy of Pediatrics in a letter to Dr. Janet Woodcock, acting commissioner of the FDA.
The urgent appeal comes as the United States has experienced “the largest week-over-week percentage increase in pediatric Covid cases since the start of the pandemic,” Dr Lee Savio Beers wrote Thursday, president of the academy.
Pediatric cases of Covid-19 have skyrocketed in recent weeks in part due to the highly contagious delta variant, sparking concerns among parents and doctors just as schools reopen for the fall semester.
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“The delta variant has created a new and pressing risk for children and adolescents across the country,” Beers wrote in a letter to the FDA.
According to the latest data available from the Pediatric Academy, 38,654 pediatric cases of Covid were reported during the week of July 22. In one week, on July 29, that number jumped 85% to 71,726.
Already, parents of young children are increasingly asking their children’s pediatricians for Covid-19 vaccines, said pediatrician Dr Richard Besser, former acting director of the Centers for Disease Control and Prevention.
“I have had parents with children as young as 9 years old who requested the vaccine,” said Besser, who is now president of the Robert Wood Johnson Foundation. “We had to say no.
Only the Pfizer-BioNTech Covid vaccine has been authorized for adolescents and adolescents, aged 12 to 17 years.
While the Covid vaccines used in the United States have been shown to be generally safe and very effective in preventing serious illness in adolescents and adults, vaccinating young children requires further investigation and study.
In other words, children are not just little adults. In general, children need a lower dose of products that boost the immune system, such as the Covid-19 vaccine, than adults.
Children “need a single dose, and maybe even a unique timing” to space these injections, said Dr. Natasha Burgert, spokesperson for the American Academy of Pediatrics and medical practitioner at Overland Park. , Kansas.
“Maybe they need two doses. Maybe they need one, maybe three. I don’t know. We haven’t seen any of that data,” said Burgert.
The three companies with Covid-19 vaccines in use in the United States – Johnson & Johnson, Moderna and Pfizer-BioNTech – are all trying to answer these questions through research in pediatric trials.
Pfizer expects data on children aged 5 to 11 in September, with data on toddlers up to 4 years soon after. Moderna’s timeline for data on children is likely later this fall or early winter.
The FDA has requested four to six months of follow-up data on the safety of clinical trials in children, compared to two months of follow-up data required for adult vaccine trials. In his letter, Beers wrote that the spread of the delta made authorization of the vaccine for 5 to 11 year olds more urgent and that waiting for a six-month follow-up would be a risky delay.
“Based on the scientific data currently available on COVID-19 vaccines, as well as on 70 years of knowledge of vaccinology in the pediatric population, the Academy believes that clinical trials in these children can be conducted safely with follow-up 2 month safety period for participants, ”Beers wrote.
That’s because vaccine-related adverse events shouldn’t appear after a month or two after the shot, according to experts. Still, doctors say they need time to sort out other side effects, mostly to reassure parents.
“A sore arm in a 40-year-old is very different from a sore leg in an 11-month-old who begins to walk,” said Dr Buddy Creech, principal investigator of Moderna’s KidCOVE study. “We need to understand what these side effects look like and which are normal, so that we can tell parents what to expect.”
An FDA official previously suggested to NBC News that the first Covid-19 vaccine for children under 12 could arrive as early as “in the middle of winter.”
This fits the timeline predicted by Creech.
“I imagine that in late fall and early winter we will have enough data to be able to make recommendations for these vaccines” for children 11 and under, he said. .
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Research requires a delicate balance of risk, according to Creech. If children are given too many vaccines, they can have increased side effects.
On the other hand, “giving too little can lead to a false sense of security without real protection,” he said. “We have to really work hard to find the right dose. We’re getting there. But it takes time.”
The FDA did not respond directly to the letter from the American Academy of Pediatrics, instead referring to previous statements from Dr. Peter Marks, director of the FDA Center for Biologics Evaluation and Research.
Pediatric vaccine studies “are taking a little longer to do because we need longer follow-up to make sure the safety is adequate,” Marks said on a call with stakeholders in late June.
The FDA has asked vaccine manufacturers to increase the number of participants in the pediatric study to try to detect rare side effects, such as myocarditis, an inflammation of the heart, in some young people who received the Johnson & Johnson vaccine .
Doctors on the front lines of the increase in pediatric Covid-19 cases continue to insist the vaccine is the best and safest way out of the pandemic, even for young people.
“I wish we didn’t have to be in this place,” said Dr. Sean O’Leary, vice chair of the American Academy of Pediatrics’ infectious disease committee. “It was preventable.”
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