Pfizer studied low doses of the two-shot COVID-19 vaccine in more than 2,200 kindergarten and elementary school children.
The vaccine produced by Pfizer and its German partner BioNTech is already available to anyone over the age of 12. But now that children are back in school and the highly contagious delta mutations are causing a significant increase in pediatric infections, many parents are worried about vaccination of young 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 coronavirus as strong as teens and young adults, said Dr. Bill Gruber, senior vice president of Pfizer, the Associated Press. I told the Associated Press.
Dosages for children have also proven to be safe, and he said that teens experience the same or less temporary side effects (arm pain, fever, pain, etc.).
“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.
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 in smaller doses.However Cuba Last week, Chinese regulators cleared two brands up to the age of three, starting immunization of children up to the age of two with a homemade vaccine.
Children are at lower risk of serious illness and death than older people, according to the American Academy of Pediatrics, but since the outbreak of the pandemic, more than 5 million children have been COVID-19-positive in the United States, at least 460. Is dead. As delta variants swept across the country, child cases increased dramatically.
Gruber says he “is very 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 it studied low doses in 2,268 kindergarten and elementary school children. The FDA has called for so-called immune “bridged” research. This is evidence that infants have developed antibody levels that have already proven to be defensive in teens and adults. This was reported by Pfizer in a press release on Monday and is not a scientific publication. There are still no COVID-19 cases in progress and sufficient to compare rates between vaccinated and placebo-something that may provide additional evidence.
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. Once the vaccine is approved for young children, Pfizer’s Gruber, like everyone else, will be 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.
AP journalist Emma Tobin contributed to this report.
The Associated Press’s Department of Health Sciences is supported by the Department of Science Education at the Howard Hughes Medical Institute. AP is solely responsible for all content.
When will the COVID vaccine be available to children under the age of 12?
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