Washington: pfizer On Wednesday the US asked to authorize extra-low doses of its COVID-19 vaccine for children under the age of 5, potentially for the youngest Americans to start receiving shots in early March .
In an extraordinary move, Food and Drug Administration Pfizer and its partner BioNTech were urged to apply ahead of the companies’ plan.
The country’s 19 million children under the age of 5 are the only group not yet eligible for vaccination against the coronavirus. Many parents are pushing for the expansion of shots for toddlers and preschoolers, especially since the Omicron wave sent record numbers of young people to the hospital.
If FDA Agreed, Pfizer shots can be given to babies under 6 months of age just one-tenth of the dose given to adults. Pfizer said Wednesday that it has begun submitting its data to the FDA and expects to complete the process in a few days.
An open question is how many shots would those youngsters need. Pfizer is testing three shots because two extra-low doses are strong enough for infants but not for preschoolers, and final data from the study is not expected until late March.
That means the FDA could consider whether to authorize two shots for now, potentially allowing a third shot to be approved later if the study backs it up.
The FDA said Tuesday it would convene a panel of independent researchers and physicians in mid-February to help review the Pfizer data. The agency is not required to follow the advice of the panelists, but their input is an important step in publicly examining the vaccine’s safety and effectiveness.
The FDA’s final decision could come within months but it’s not the only hurdle. Centers for Disease Control and Prevention You also have to sign off.
Biden The administration is trying to speed up the authorization of COVID-19 shots for children, immunizations are important to keep schools and day care centers open and to keep them open, and to free parents from child care duties so they can work. But can go back.
Yet vaccination rates among children have been low compared to other age groups. As of last week, only 20 percent of children aged 5 to 11 and more than half of children aged 12 to 17 were fully vaccinated. American Academy of Pediatrics, About three-quarters of adults are fully vaccinated.
While young children are much less likely to become seriously ill from the coronavirus than adults, it can happen, and pediatric COVID-19 infections are higher than at any other point in the pandemic.
“What we’re seeing right now is there’s still a lot of hospitalizations and unfortunately some deaths in this age group,” said Dr. Ean O’Leary of the University of Colorado, who is on the AAP’s infectious diseases committee. If the FDA approves vaccinations for these young people, “it’s going to be really important because all those hospitalizations and deaths are essentially preventable.”
For children younger than 5 years old, Pfizer’s study is giving participants two shots three weeks apart, followed by a third dose at least two months later. The company is testing whether youth produces antibody levels similar to the antibodies known to protect teens and young adults.
In December, Pfizer announced that children under 2 years of age should be protected, but the antibody response was very low in children 2 to 4 years old. It’s not clear why, but one possibility is that the extra-low dosage for preschoolers was a little too low.
Because preliminary results showed the shots were safe, Pfizer added a third dose to the trial in hopes of improving safety.
Given how well boosters are working for older age groups, “it makes some sense” that younger children might benefit from a third shot, O’Leary said.
“I can certainly understand where both the company and the FDA are coming from in terms of willingness to take this along, anticipating that there’s going to be a third dose down the line.”
In an extraordinary move, Food and Drug Administration Pfizer and its partner BioNTech were urged to apply ahead of the companies’ plan.
The country’s 19 million children under the age of 5 are the only group not yet eligible for vaccination against the coronavirus. Many parents are pushing for the expansion of shots for toddlers and preschoolers, especially since the Omicron wave sent record numbers of young people to the hospital.
If FDA Agreed, Pfizer shots can be given to babies under 6 months of age just one-tenth of the dose given to adults. Pfizer said Wednesday that it has begun submitting its data to the FDA and expects to complete the process in a few days.
An open question is how many shots would those youngsters need. Pfizer is testing three shots because two extra-low doses are strong enough for infants but not for preschoolers, and final data from the study is not expected until late March.
That means the FDA could consider whether to authorize two shots for now, potentially allowing a third shot to be approved later if the study backs it up.
The FDA said Tuesday it would convene a panel of independent researchers and physicians in mid-February to help review the Pfizer data. The agency is not required to follow the advice of the panelists, but their input is an important step in publicly examining the vaccine’s safety and effectiveness.
The FDA’s final decision could come within months but it’s not the only hurdle. Centers for Disease Control and Prevention You also have to sign off.
Biden The administration is trying to speed up the authorization of COVID-19 shots for children, immunizations are important to keep schools and day care centers open and to keep them open, and to free parents from child care duties so they can work. But can go back.
Yet vaccination rates among children have been low compared to other age groups. As of last week, only 20 percent of children aged 5 to 11 and more than half of children aged 12 to 17 were fully vaccinated. American Academy of Pediatrics, About three-quarters of adults are fully vaccinated.
While young children are much less likely to become seriously ill from the coronavirus than adults, it can happen, and pediatric COVID-19 infections are higher than at any other point in the pandemic.
“What we’re seeing right now is there’s still a lot of hospitalizations and unfortunately some deaths in this age group,” said Dr. Ean O’Leary of the University of Colorado, who is on the AAP’s infectious diseases committee. If the FDA approves vaccinations for these young people, “it’s going to be really important because all those hospitalizations and deaths are essentially preventable.”
For children younger than 5 years old, Pfizer’s study is giving participants two shots three weeks apart, followed by a third dose at least two months later. The company is testing whether youth produces antibody levels similar to the antibodies known to protect teens and young adults.
In December, Pfizer announced that children under 2 years of age should be protected, but the antibody response was very low in children 2 to 4 years old. It’s not clear why, but one possibility is that the extra-low dosage for preschoolers was a little too low.
Because preliminary results showed the shots were safe, Pfizer added a third dose to the trial in hopes of improving safety.
Given how well boosters are working for older age groups, “it makes some sense” that younger children might benefit from a third shot, O’Leary said.
“I can certainly understand where both the company and the FDA are coming from in terms of willingness to take this along, anticipating that there’s going to be a third dose down the line.”
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