COVID-19 vaccine
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When Will the Pfizer Vaccine Be Approved for Children Under 12?

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Sep. 30 2021, Published 12:43 p.m. ET

Many children have returned to school. As a result, parents are anxious for COVID-19 vaccine approval for children younger than 12 years old. Currently, none of the COVID-19 vaccines are authorized for children under 12 years old. Pfizer is leading this race. Pfizer and BioNTech submitted initial data to the FDA for EAU (emergency use authorization) for children under 12 years old. When will the Pfizer vaccine be approved for children under 12?

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The Pfizer-BioNTech COVID-19 vaccine was the first vaccine to get full approval from FDA on August 23, 2021. It was also the first vaccine to get EAU from the FDA in December 2020.

Benefit of getting full approval for COVID-19 vaccines

According to some surveys, getting full approval increases people’s faith in vaccines. According to the White House's chief medical adviser, Dr. Anthony Fauci, the FDA's "official stamp of approval" could convince as many as 20 percent of the 90 million vaccine-eligible people in the U.S. who are still unvaccinated to sign up.

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After full approval, companies can directly market the vaccines to consumers. Companies can reach more potential customers and generate more revenue. Also, full authorization allows a company to continue selling its vaccine even after the COVID-19 pandemic ends.

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Pfizer-BioNTech submit data for vaccine for children under 12

Pfizer is marketing its vaccine as Comirnaty for the prevention of COVID-19 in individuals 16 years of age and older. Pfizer and BioNTech submitted the initial data to the FDA from the Phase 2/3 trial of its vaccine in children 5–12 years of age on Sept. 28. The companies announced positive topline results from the trial on Sept. 20. The vaccine has demonstrated a favorable safety profile.

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The companies mentioned that these results were comparable to those recorded in a previous Pfizer-BioNTech study in people 16–25 years of age. However, the companies selected 10 μg doses for children under 12 years of age compared to 30 μg for people who are 16–25 years old.

When will the Pfizer vaccine be approved for children under 12?

Pfizer and BioNTech mentioned that a formal submission to request EAU for their COVID-19 vaccine in children 5–12 years old will follow in the coming weeks. Previously, the companies were targeting submitting the application by the end of September. Pfizer’s board member, Dr. Scott Gottlieb told CNBC that it's still possible that the FDA will approve Pfizer and BioNTech’s COVID-19 vaccine for young kids by Halloween (Oct. 31).

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However, The Wall Street Journal cited a person familiar with the matter who mentioned that the EAU for the Pfizer vaccine for younger children might not come until November. Pfizer isn't expected to complete its application process until mid-October. This means that the FDA might not reach its decision before mid-November.

Delta variant spread increases the urgency for vaccine approval.

Parents and schools are eagerly awaiting COVID-19 vaccine approval for younger children. The vaccine could help stem the spread of the contagious Delta variant. While young children face less risk of getting the severe disease and being hospitalized, the Delta variant has increased the number of children going to hospitals for treatment.

The FDA said in September that it was “working around the clock” to help make vaccines available for children under 12 years old. However, testing and the regulatory process need to play out.

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