Pfizer submits to FDA for approval of 3 doses of COVID-19 vaccine for children aged 5-11
Pfizer and BioNTech said that they have applied to the US Food and Drug Administration (FDA) for an emergency authorization to use a booster dose of COVID-19 vaccine for children aged 5-11 years.
This pharmaceutical company said that a 3-dose dose of COVID-19 vaccine aimed to increase anti-Omicron antibodies 36 times for ages 5-11.
In an analysis of 140 children who had never had COVID-19 before, antibodies against the original strain of SARS-CoV-2 were six times higher 1 month after dose 3 compared with dose 2.
Research from the New York State Department of Health and the US Centers for Disease Control and Prevention (CDC) shows that the anti-infective effectiveness of the Pfizer vaccine for children aged 5-12 is significantly reduced due to the Omicron wave, reduced from 68% to about 12% of the anti-infective effect.
However, getting two full doses of the COVID-19 vaccine continues to protect children from severe COVID-19 disease. This figure is evident in hospitalizations or emergencies due to COVID-19.
More than 10,000 children aged 6 months to 12 years have participated in a worldwide trial of Pfizer’s COVID-19 vaccine.
Pfizer hopes to submit data on trials in children under the age of 5 in the coming months.
Children under 5 are the only age group that has not yet been approved for a COVID-19 vaccine in the United States.
Pfizer/BioNTech said it plans to submit the data to the European Medicines Agency and other regulators for approval in the coming weeks.
Pfizer’s two-dose course of COVID-19 vaccine for children aged 5-11 was approved in the US last October.
Booster doses are also available for immunocompromised children 12 years of age and older, as well as for adults. A four-dose dose of the COVID-19 vaccine has been approved for anyone 50 years of age or older.
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