Pfizer said Monday that the COVID-19 vaccine is effective for children aged 5 to 11 years and will soon seek US approval for this age group. This is an important step in starting vaccination of young people.
NS vaccination Manufactured by Pfizer and its German partner BioNTech, it is already available to anyone over the age of 12.However, many parents are worried about vaccination of their children as they return to school and the highly contagious delta variants are causing a significant increase in pediatric infections. Children..
For elementary school children, Pfizer tested a much lower dose — one-third of the amount currently in each shot given. However, after the second dose, children aged 5 to 11 developed antibody levels that fight the coronavirus as strong as teenagers. Young adult Dr. Bill Gruber, Senior Vice President of Pfizer, told The Associated Press.
Dosages for children have also proven to be safe, with the same or less temporary side effects experienced by teens, such as arm pain, fever, and pain, he said.
“I think we really have reached the sweet spot,” said Gruber, who is also a pediatrician.
According to Gruber, the two companies aim to apply to the Food and Drug Administration by the end of the month for emergency use in this age group, and soon afterwards to regulatory agencies in Europe and the United Kingdom.
Early this monthFDA Chief Dr. Peter Marks tells AP that when Pfizer submits his findings, his agency evaluates the data “preferably within a few weeks” and the shots are safe and effective enough for young children. He said he would decide if.
External experts said scientists wanted to see more details, but said the report was encouraging.
“These top-line results are very good news,” said former FDA Vaccine Chief Dr. Jesse Goodman of Georgetown University. The level of immune response reported by Pfizer is reported to be “likely protective.”
So far, many Western countries have been vaccinated over the age of 12 and are waiting for evidence of what the appropriate dose is and that it works safely. Cuba Last week, children up to the age of two began immunizing with a homemade vaccine, and Chinese regulators cleared two brands up to the age of three.
While the child is at low risk of serious illness or death senior citizenAccording to the American Academy of Pediatrics, more than 5 million children have been COVID-19-positive and at least 460 have died in the United States since the outbreak of the pandemic. As delta variants dominate the country, cases of children are increasing.
Gruber said he was “extremely urgent” to make the vaccine available to children under the age of 12. “There is a disgusting demand for parents to be able to bring their children back to normal life.”
In New Jersey, 10-year-old Maya Huber asked why she couldn’t be vaccinated as her parents and both teenage siblings had. Her mother, Dr. Nisha Gandhi, a critical care physician at Inglewood Hospital, enrolled Maya in the Pfizer study at Rutgers University. However, the family has not mitigated masking or other viral precautions until they know if Maya has received a genuine vaccine or dummy shot.
Knowing that she is protected, Maya’s first goal is “a large oversleep with all my friends.”
Maya said participating in the study was exciting, even though she was “very scared” about being jabed. But “after getting it, at least you were happy with it and relieved that it wasn’t hurt,” she told AP.
Pfizer said he studied low doses in 2,268 kindergarten and elementary school children. The FDA has called for so-called immune “bridging” studies: evidence that younger children have developed Antibody level Already proven to be protective in teens and adults. It was reported by Pfizer in a press release on Monday, not a scientific publication. Studies are still underway and there are not yet enough COVID-19 cases to compare rates between vaccinated and placebo-what may provide additional evidence. mosquito.
This study is not large enough to detect very rare side effects, such as heart inflammation that sometimes occur after the second dose, mainly in young men. The FDA’s mark said pediatric studies must be large enough to rule out higher risks to young children.Pfizer’s Gruber said the vaccine will be approved Young children, Like everyone else, is carefully monitored for rare risks.
Moderna, the second US vaccine maker, is also studying the shots for elementary school children. Pfizer and Moderna are also studying younger children up to 6 months old. Results are expected later this year.
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Quote: According to Pfizer, the COVID-19 vaccine works in children aged 5-11 years (September 20, 2021) and on September 20, 2021 https://medicalxpress.com/news/2021-09-pfizer Obtained from -covid-vaccine-kids-ages.html.
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According to Pfizer, the COVID-19 vaccine works for children aged 5 to 11 years.
Source link According to Pfizer, the COVID-19 vaccine works for children aged 5 to 11 years.