Pfizer is moving forward with new clinical tests on thousands of children under the age of 12 as they look to expand the authorization of its COVID-19 vaccine.
The company announced on Tuesday, June 8 that it will enroll up to 4,500 children between the ages of 6 months and 12 years old in the United States, Finland, Poland, and Spain with the intention of getting emergency use authorization before school begins in the fall.
Currently, the Pfizer vaccine has only been authorized for use in children 12 and older.
According to Pfizer, it has selected a dose of 10 micrograms in children between 5 and 11 years old and three micrograms for infants between the ages of 6 months and 5 years old.
Pfizer officials said they aim to ask the Food and Drug Administration for an emergency use authorization to use its drug to vaccinate children from 5 to 11 years in September or October. Company officials said they expect to apply for an emergency use authorization to vaccinate children between 6 months and 5 years old “soon after.”
“Today marks an important next step in our efforts to understand the safety and immune response of our COVID-19 vaccine," Dr. Bill Gruber, the senior vice president of clinical research and development at Pfizer, said in a statement. In the coming weeks, Phase 2/3 trials will start for 2- to 4-year-olds, as well as those as young as six months.
”We take a deliberate and careful approach to help us understand the safety and how well the vaccine can be tolerated in younger children.”
Gruber added: “Children younger than 12 make up a significant portion of the total global population and can develop COVID-19 disease, and also can spread the virus to others.
“If successful, we believe vaccinating children will help further protect our communities and contribute to the evolving herd immunity.”
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