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pfizer: Pfizer asks FDA to allow Covid-19 vaccine for kids under 5


WASHINGTON: Pfizer asked the United States on Wednesday to authorize ultra-low doses of its Covid-19 vaccine for children under the age of 5, potentially paving the way for the youngest Americans to begin getting the vaccine as early as May. Three.
In an extraordinary move, Food and Drug Administration urged Pfizer and its BioNTech partner to apply earlier than the companies planned.
The nation’s 19 million children under the age of 5 are the only group not yet eligible to be vaccinated against the coronavirus. Many parents have pushed for the expansion of shots to toddlers and preschoolers, especially as the omicron wave has sent record numbers of babies to hospitals.
If FDA agrees, Pfizer injections containing only one-tenth of the adult dose may be dispensed to children under 6 months of age. Pfizer said Wednesday that it has begun submitting its data to the FDA and expects to complete the process within the next few days.
An open question is how many noses will those children need. Pfizer is testing three shots after two of the ultra-low doses turned out to be potent enough for infants but not enough for preschoolers, and final data from the study is not expected until the end of March. .
That means the FDA could consider whether to allow two shots now, with the possibility of a third shot later if research backs it up.
The FDA said Tuesday it will 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 panelists’ advice, but their input is an important step in publicly testing vaccine safety and effectiveness.
The FDA’s final decision could be made within a month, but that’s not the only hurdle. The Centers for Disease Control and Prevention also have to log out.
The Biden As the government has been working to speed up the licensing of children’s COVID-19 vaccines, competitive immunizations are crucial to opening schools and day care centers and keeping them afloat, and solving problems. Frees parents from childcare duties so they can go back to work.
However, vaccination rates among children are lower than in other age groups. As of last week, just 20% of children aged 5 to 11 and just over half of children aged 12 to 17 had been fully immunized, according to American Academy of Pediatrics. Nearly three-quarters of adults are fully immunized.
Although young children are at much lower risk of severe illness from coronavirus than adults, it can happen, and COVID-19 infections in children are higher than at any other point in the pandemic.
“What we’re seeing right now is still a lot of hospitalizations and, unfortunately, some deaths,” said Dr. death at this age. If the FDA removes vaccination of these young people, “that will be really important because all hospitalizations and deaths are essentially preventable.”
For children younger than 5 years of age, the Pfizer study gave participants two injections three weeks apart, followed by a third dose at least two months later. The company is testing to see if young people produce levels of antibodies similar to those known to protect teenagers and young adults.
In December, Pfizer announced that children under 2 years of age appear to be protected but antibody responses are too low in children aged 2 to 4 years. It’s not clear why, but there is a possibility that the extremely low dose is a bit too low for preschoolers.
Because preliminary results showed the shots were safe, Pfizer added a third dose to the trial, hoping to improve protection.
According to O’Leary, given how effectively boosters work for older age groups, it “may make sense” that younger children could benefit from a third shot.
“I can certainly understand where both the company and the FDA are coming from when it comes to this diversion, anticipating that there will be a third dose down the line.”





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