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Pfizer says COVID-19 vaccine is safe and works in kids ages 5 to 11 – New Orleans, Louisiana

New Orleans, Louisiana 2021-09-20 08:09:00 –

Video above: FDA panel backs boosters for seniors and high-risk individuals Pfizer said Monday that the COVID-19 vaccine is effective for children aged 5-11 and will soon seek US approval for this age group -An important step in starting vaccination of young people. The vaccine produced by Pfizer and its German partner BioNTech is already available to anyone over the age of 12. However, many parents are worried about vaccination of young children as their children return to school and the highly contagious delta variants are causing a significant increase in pediatric infections. Of the amount in each shot given now. 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, a pediatrician. Gruber said the two companies are aiming to apply to the Food and Drug Administration by the end of the month for emergency use in this age group. Application to European and UK regulatory agencies. Earlier this month, FDA chief Dr. Peter Marks told AP that once Pfizer submitted the findings, his agency would evaluate the data “preferably within a few weeks” and the shots would be safe enough for young children. He said he would decide if it was effective. 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 with smaller tots. However, Cuba launched immunization of children up to the age of two with a homemade vaccine last week, and Chinese regulators have cleared two brands up to the age of three. Children have a lower risk of serious illness and death than older people, but more than 5 million children have tested positive for COVID-19 since the beginning of the pandemic, according to the American Academy of Pediatrics. At least 460 people have died. As delta variants swept across the country, child cases increased dramatically. Gruber said he was “extremely urgent” to make the vaccine available to children under the age of 12. In New Jersey, 10-year-old Maya Huber asked why she wasn’t vaccinated like her parents and teenage siblings. 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 Maya is protected, Maya’s first goal is to “massive sleep with all her friends.” Despite being “very scared” about her being jabbed, she said it was exciting to participate in the study. But “after getting it, at least you were happy to do 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. It is evidence that young children have developed antibody levels that have already proven to be defensive in teens and adults. It was reported by Pfizer in a press release on Monday, not a scientific publication. Studies are still ongoing and there are not yet enough COVID-19 cases to compare rates between vaccinated and placebo-may provide additional evidence. .. Studies are not large enough to detect very rare aspects, mainly in young men, effects such as cardiac inflammation that sometimes occur after the second dose. 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, it will be closely monitored for the same rare risks as others, according to Pfizer’s Gruber. Moderna, the second largest vaccine maker in the United States, is also studying vaccination 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.

Video above: FDA Panel Supports Boosters for Elderly, High-Risk Individuals

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 initiating vaccination of young people.

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.

Earlier this month, FDA chief Dr. Peter Marks told AP that once Pfizer submitted the findings, his agency would evaluate the data “preferably within a few weeks” and the shots would be safe enough for young children. He said he would decide if it was effective.

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 began immunizing children up to the age of two with homemade vaccines last week, and Chinese regulators have cleared two brands up to the age of three.

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 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 it studied low doses in 2,268 kindergarten and elementary school children. The FDA has called for so-called immune “bridged” research. It is evidence that young children have developed antibody levels that have already proven to be defensive 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. 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.

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