Although the Pfizer vaccine is FDA approved for adults, it is still not recommended for children under the age of 12
Leading pediatricians on Monday advised doctors not to administer COVID-19 vaccines to children under 12.
This off-label use is now authorized under full FDA approval of the Pfizer-COVID-19 vaccine by BioNTech. However, a number of experts believe this is a bad idea.
“We have no information on young children. It should be banned, right? Jesse Goodman, an infectious disease expert at Georgetown University, agrees. "Science does not currently support dosing for young children."
COVID-19 vaccines have not yet been licensed for children under the age of 12, as they have yet to be shown to be safe and effective in this age group. Additionally, while everyone aged 12 and over receives the same dose, Goodman and others believe that a five-year-old may need fewer vaccines than a 55-year-old man.
Pfizer and its German partner BioNTech plan to complete studies in children aged 5 to 11 this fall, and trials in young children are not expected until late this year or early next year.
Dr. Lee Saviveo Bierce, president of the American Academy of Pediatrics, said in a prepared statement that "we need to see the evidence from these studies before providing this vaccination to young children." "Until the FDA approves the vaccine, the AAP does not recommend giving it to children under the age of 12."
Adolescents 12 and older who are already eligible for vaccination should be vaccinated as soon as possible, according to the Association of Pediatricians. “Data from clinical trials and four months of immunization experience in these adolescents suggests that the vaccine is safe and effective in this age group,” Bierce said.
Instead of being vaccinated, children under 12 should wear masks in school and in public places, avoid crowds and wash their hands frequently, according to public health officials.
Dr. Bob Frank, principal investigator for vaccine research at Pfizer and head of the Vaccine Research Center at Cincinnati Children's Hospital Medical Center, said in an email: “While we wait for the vaccine, we have questions. successful measures. "Masks can reduce the risk of infection by about 85%, and proper distance can reduce it by about 82%."
Administration of doses for adults may cause unwanted side effects.
“Although the side effects are temporary and mild, if you can eliminate or reduce the side effects while maintaining the same immunological response, this is the way to go,” Frank said.
Several vaccines, including the vaccine developed by Pfizer-BioNTech, have been shown to increase the risk of myocarditis or edema of the heart muscle. Although the side effect was more common in young men and adolescents, it was rare - affecting only 1 in 20,000 people vaccinated - and most cases resolved quickly. It is not known whether the inflammation will affect young adults as well.
In a briefing Monday, Dr Paul Offit, pediatric infectious disease expert at Children's Hospital of Philadelphia, said: "We have certainly had a lot of children in our hospital with (myocarditis)."
Offit, who helped create a vaccine against rotavirus, which causes diarrhea in infants and toddlers, and ran a vaccine education center in his hospital, said, “I'm a vaccine fanatic. "Until I see the data, I will not be immunizing my 9 or 10 year old."
Dr Yvonne Maldonado, chair of the AAP Infectious Disease Committee, said in a statement that doctors shouldn't wonder what lower dose might be safe and effective for a child.
In a statement, Maldonado added, "We don't want individual physicians to calculate doses and dosing schedules for young children based on the experience of vaccinating older patients." "We have to do it on the basis of all the evidence for each age group, and we need the trials to be completed to do this."
The American Academy of Pediatrics has asked the FDA to speed up the approval process for vaccines for children under 12, relying on data from early trials rather than waiting for more comprehensive results.
According to the AAP, around 180,000 children and adolescents were infected with the coronavirus during the week ending in August. 19, almost all were deltoids. Nearly 4.6 million children have been infected since the outbreak, accounting for almost 15% of all cases, and infection rates have quadrupled in the last month alone, nearing their peak last winter . Childhood hospitalization and death rates are still low.
“We know parents want to protect their children with this vaccine, and the American Academy of Pediatrics shares this emergency,” Bierce said. “While we wait for vaccine approval for young children, it is imperative that all eligible people receive the vaccine now. This will limit the spread of the virus and protect children too young to be vaccinated. "
This off-label use is now authorized under full FDA approval of the Pfizer-COVID-19 vaccine by BioNTech. However, a number of experts believe this is a bad idea.
“We have no information on young children. It should be banned, right? Jesse Goodman, an infectious disease expert at Georgetown University, agrees. "Science does not currently support dosing for young children."
COVID-19 vaccines have not yet been licensed for children under the age of 12, as they have yet to be shown to be safe and effective in this age group. Additionally, while everyone aged 12 and over receives the same dose, Goodman and others believe that a five-year-old may need fewer vaccines than a 55-year-old man.
Pfizer and its German partner BioNTech plan to complete studies in children aged 5 to 11 this fall, and trials in young children are not expected until late this year or early next year.
Dr. Lee Saviveo Bierce, president of the American Academy of Pediatrics, said in a prepared statement that "we need to see the evidence from these studies before providing this vaccination to young children." "Until the FDA approves the vaccine, the AAP does not recommend giving it to children under the age of 12."
Adolescents 12 and older who are already eligible for vaccination should be vaccinated as soon as possible, according to the Association of Pediatricians. “Data from clinical trials and four months of immunization experience in these adolescents suggests that the vaccine is safe and effective in this age group,” Bierce said.
Instead of being vaccinated, children under 12 should wear masks in school and in public places, avoid crowds and wash their hands frequently, according to public health officials.
Dr. Bob Frank, principal investigator for vaccine research at Pfizer and head of the Vaccine Research Center at Cincinnati Children's Hospital Medical Center, said in an email: “While we wait for the vaccine, we have questions. successful measures. "Masks can reduce the risk of infection by about 85%, and proper distance can reduce it by about 82%."
Administration of doses for adults may cause unwanted side effects.
“Although the side effects are temporary and mild, if you can eliminate or reduce the side effects while maintaining the same immunological response, this is the way to go,” Frank said.
Several vaccines, including the vaccine developed by Pfizer-BioNTech, have been shown to increase the risk of myocarditis or edema of the heart muscle. Although the side effect was more common in young men and adolescents, it was rare - affecting only 1 in 20,000 people vaccinated - and most cases resolved quickly. It is not known whether the inflammation will affect young adults as well.
In a briefing Monday, Dr Paul Offit, pediatric infectious disease expert at Children's Hospital of Philadelphia, said: "We have certainly had a lot of children in our hospital with (myocarditis)."
Offit, who helped create a vaccine against rotavirus, which causes diarrhea in infants and toddlers, and ran a vaccine education center in his hospital, said, “I'm a vaccine fanatic. "Until I see the data, I will not be immunizing my 9 or 10 year old."
Dr Yvonne Maldonado, chair of the AAP Infectious Disease Committee, said in a statement that doctors shouldn't wonder what lower dose might be safe and effective for a child.
In a statement, Maldonado added, "We don't want individual physicians to calculate doses and dosing schedules for young children based on the experience of vaccinating older patients." "We have to do it on the basis of all the evidence for each age group, and we need the trials to be completed to do this."
The American Academy of Pediatrics has asked the FDA to speed up the approval process for vaccines for children under 12, relying on data from early trials rather than waiting for more comprehensive results.
According to the AAP, around 180,000 children and adolescents were infected with the coronavirus during the week ending in August. 19, almost all were deltoids. Nearly 4.6 million children have been infected since the outbreak, accounting for almost 15% of all cases, and infection rates have quadrupled in the last month alone, nearing their peak last winter . Childhood hospitalization and death rates are still low.
“We know parents want to protect their children with this vaccine, and the American Academy of Pediatrics shares this emergency,” Bierce said. “While we wait for vaccine approval for young children, it is imperative that all eligible people receive the vaccine now. This will limit the spread of the virus and protect children too young to be vaccinated. "
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