Pfizer and BioNTech said on Monday that test results showed that their coronavirus vaccine was safe and provided a strong immune response in children aged 5 to 11 years, and would soon seek regulatory approval. Added.
NS vaccination They said they would be given at lower doses than people over the age of 12.
“For participants aged 5 to 11, the vaccine was safe, tolerated, and showed a strong neutralizing antibody response,” US giant Pfizer and its German partner said in a joint statement.
They plan to submit data “as soon as possible” to regulators in the European Union, the United States, and around the world.
Ashish Jha, Dean of the Brown University School of Public Health and a leading US COVID expert, called it the “good news” that many parents have been waiting for.
If all goes well and gets approval, “My nine years will be shot at Halloween!” He tweeted.
The trial results are the first results for children under the age of 12, and a Moderna trial for children aged 6-11 is still underway.
Both Pfizer and Moderna jabs have already been administered to adolescents over the age of 12 in some countries and adults around the world.
England, Scotland and Wales are the latest on the list of countries to vaccinate teens and have been jabing young people aged 12 to 15 this week. Northern Ireland will follow suit next month.
Children are considered to be at low risk of severe COVID, but there are concerns that the highly contagious Delta variant can lead to more serious cases.
Inoculating children is also seen as the key to keeping the school open and helping to end the pandemic.
“We want to extend vaccine protection to these young people,” said Albert Bourla, CEO of Pfizer. Since July, pediatric cases of COVID-19 have increased by about 240% in the United States. “.
According to the two companies, children aged 5 to 11 years received a double-dose regimen of 10 micrograms in the study, compared with 30 micrograms for older children. Shots were given every 21 days.
According to the statement, the 10 microgram dose was “carefully selected as the preferred dose for safety, tolerability and immunogenicity” for that age group.
The side effects were “generally similar to those observed in participants aged 16 to 25,” he added.
Some of the most commonly reported side effects in the past are pain and swelling at the injection site, headache, chills and fever.
The Pfizer-BioNTech statement does not mention the rare side effects of myocarditis, a vaccine-related myocardial inflammation, primarily among young men.
Under 5 years old by the end of the year
The Pfizer vaccine was fully officially approved in the United States in August and is technically available to young children with a doctor’s prescription, but U.S. authorities will do this until safety data is available. I warn you not.
The U.S. regulator, the Food and Drug Administration (FDA), said in a statement earlier this month that it would “carefully” consider urgent license requests for vaccines under the age of 12. This process was expected to take “weeks instead of months”.
Israel has already given special permission from COVID to vaccinate children aged 5-11 years who are “at significant risk of serious illness or death” using low doses of Pfizer jab.
Pfizer and BioNTech are also testing vaccines for babies aged 6 months to 2 years and children aged 2 to 5 years.
The top-line results of these trials are expected “immediately” in the fourth quarter of this year, the two companies said.
Up to 4,500 in total Children Ages 6 months to 11 years are enrolled in the Pfizer-BioNTech trials in the United States, Finland, Poland and Spain.
Like its Moderna rivals, Pfizer Jab is based on a new mRNA technology that gives cells genetic instructions to build coronavirus peplomer proteins to evoke antibodies when the body encounters a real virus. ..
© 2021 AFP
Quote: Pfizer is 5-11 years old (September 20, 2021) obtained from https://medicalxpress.com/news/2021-09-pfizer-covid-jab-safe-children.html on September 20, 2021. Say COVID Jab Safe for Kids (Sun)
This document is subject to copyright. No part may be reproduced without written permission, except for fair transactions for personal investigation or research purposes. The content is provided for informational purposes only.
Pfizer Says COVID Jab Safe for Children 5-11 Years Old
Source link Pfizer Says COVID Jab Safe for Children 5-11 Years Old