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American Academy of Pediatrics urges FDA to quickly expand approval of COVID-19 vaccines to younger age groups, citing increase in cases due to rapid spread of delta variant and risk of poor outcomes after infection.
“We need to approach the testing and authorization of the COVID vaccine for children with the same urgency as we have done with adults,” AAP president Dr. Lee Savio Beers told co-hosts of ‘ABC. “Just as it is a serious illness in adults, it can be a very serious illness in children.”
INCREASE IN CHILDREN’S HOSPITAL ADMISSIONS SECULES THE ALARM BEFORE THE SCHOOL YEAR
Pfizer has announced plans to seek emergency authorization for the use of its vaccine in children aged 5 to 11 by the end of September, with the intention of submitting data on younger children aged 6 months to 5 years “shortly thereafter”. The FDA had asked the drug makers behind the licensed COVID-19 vaccines to expand the size of pediatric clinical trials to better detect rare adverse events. Moderna previously told Fox News that he expects to “have a package supporting clearance in winter 2021 / early 2022” for children under 12.
Sources within the FDA previously told Fox News that the agency is seeking to extend emergency approval for Pfizer’s COVID-19 vaccine to children aged 8 and over by September. The vaccine is currently eligible for children as young as 12, and trials are underway in younger age groups.
Beers, however, argued that the size of the original trial offered enough safety and efficacy data for the FDA to weigh in on a decision on expanded authorization.
“When our experts looked at the data, they really felt very comfortable that the size of the original trial, the way the trial was originally set up, is really adequate to be able to assess the safety and effectiveness of the vaccine, ”Beers told ABC.
“The process that the FDA goes through to review and approve vaccines for adults and children is very careful, very thorough as it should be, and I think what our experts have said and weighed is that they really did. ‘feel like the data is there., will be there very soon or maybe now where the FDA can really look at this data for children and determine if the vaccine is safe and effective for them, and if it is, move it towards authorization, ”she continued.
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Beers said children can safely return to in-person classes with layered precautions such as universal masking, hand washing, physical distancing, vaccinations among eligible groups and access to testing. More and more pediatrics Admission to hospital have raised alarm as respiratory illnesses coincide and young children remain ineligible to receive COVID-19[female[feminine vaccines in the middle of the start of the school year.
However, experts say it’s not clear whether the delta variant inflicts more severe disease in children.
“We’re still learning more,” Beers said. “We are absolutely seeing an increase in the number of cases,” citing a near doubling of pediatric cases of COVID-19 in the past two weeks.
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