Pfizer and BioNTech have formally submitted a request to the US Food and Drug Administration (FDA) for approval of the COVID-19 vaccine for children aged 5 to 11 years.
“New cases of children in the United States remain at a high standard, and this submission is an important step in our ongoing commitment to # COVID19,” said Pfizer. Tweet Thursday (October 7th). “We are committed to working with the FDA with the ultimate goal of protecting children from this serious public health threat.”
Last month, the two companies announced that the COVID-19 vaccine is safe and effective for children aged 5 to 11 years, based on data from the latest clinical trials. Younger participants were given lower doses of the vaccine than were given to older children and adults. Live science previously reported..
Younger children showed antibody responses comparable to those between the ages of 16 and 25. They also tolerated the vaccine well and the side effects were similar to those seen in older age groups, the company said.
The FDA currently approves the Pfizer-BioNTech vaccine for children over the age of 16 and urgent approval for children between the ages of 12 and 15. This is the only vaccine in the United States that is allowed to be given to children under the age of 18. Year.
The FDA is tentatively planning a meeting of the Vaccine and Related Biopharmaceutical Advisory Board to discuss and review the data on October 26.
“A wealth of experience with other pediatric vaccines shows that children are not small adults. To support the safety and efficacy of vaccines used in younger pediatric populations that may be needed. We will conduct a comprehensive assessment of the submitted clinical trial data. Dosages or formulations different from those used in older pediatric populations or adults, “said Dr. Janet Woodcock, Deputy FDA Commissioner. .. Said in a statement October 1, future advisory board.
October 26th meeting will be livestreamed here..
Originally published in Live Science.
Pfizer requires FDA to approve COVID-19 vaccine for infants
Source link Pfizer requires FDA to approve COVID-19 vaccine for infants