Pfizer announced its readiness to vaccinate against COVID-19 children from 5 years old: the US authorities promise to quickly approve the request
Pfizer-BioNTech said low doses of COVID-19 vaccine are safe and effective for children 5-11 years old. USA Today.
Pfizer-BioNTech's COVID-19 vaccine is safe and effective for children aged 5 to 11, according to a new company study. Children should be given one third of the dose used for adolescents and adults.
Many parents were looking forward to the vaccines for their children who returned to school. Due to the delta strain of coronavirus, the incidence of COVID-19 among children has jumped by about 240% since July.
Children are less likely to become seriously ill with COVID-19 than adults, but they can contract and transmit the virus and sometimes suffer from serious illnesses with long-term consequences.
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The FDA and the Centers for Disease Control and Prevention will need to approve the vaccine before it becomes available to children, but government officials have promised to quickly review the data.
The authorization is likely to be issued within "a few weeks, not months," said Dr. Peter Marks of the FDA.
“The FDA is committed to addressing these issues as quickly as possible,” he added.
The Pfizer-BioNTech vaccine is currently fully approved for use in older adults and adolescents, although it is still only approved for emergency use in children 12 to 15 years of age.
“We are committed to extending the protection provided by the vaccine to this younger segment of the population, subject to regulatory approval, especially as we monitor the spread of the delta variant and the significant threat it poses to children,” said Albert Burla. Chairman and CEO of Pfizer. “These test results provide a solid basis for obtaining approval to administer our vaccine to children aged 5 to 11 years. And we plan to urgently submit this data to the FDA and other regulatory bodies. "
The Pfizer-BioNTech vaccine dose for adults is 30 micrograms, while the company offers a 10 microgram dose for children ages 5-11. As with adults, the vaccine will be given to children in two shots at least three weeks apart.
At this lower dose, the vaccine is safe for children and results in the same mostly minor side effects seen in adolescents and young adults, according to new research.
A study of 2 volunteers aged 268 to 5 years showed that they developed the same strong immune response to the vaccine as and in adolescents and young adults. Since Pfizer's vaccine has already proven its effectiveness in older groups, the company only needed to show that the vaccine is safe and induce a similar immune response in children, rather than prove again that it prevents COVID-19 disease.
The company is also investigating the use of the vaccine for children ages 2 to 5 and 6 months to 2 years of age, but these trials have not yet been completed. Young children are given 3 micrograms of the vaccine.
Participants in all three trials come from more than 90 regions in the United States, Finland, Poland and Spain, the companies say.
Two other companies licensed for COVID-19 vaccines in the United States, Moderna and Johnson & Johnson, are also exploring their child protection drugs, but have yet to complete their studies.
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