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The US FDA has approved Pfizer's Covid-19 vaccine for use in children aged 12 to 15

Princess Tarfa

The US Food and Drug Administration has extended the urgent use permit for Pfizer's COVID-19 vaccine to adults aged 12 to 15.

It's the first coronavirus vaccine in the US that has been approved for use in younger teenagers and adolescents; before, the vaccine has only been approved for adults aged 16 and over. Moderna and Johnson & Johnson's Covid-19 vaccines are approved for use in people aged 18 and up.

The FDA checked data provided by Pfizer to justify the expanded use. The firm announced at the end of March that a drug trial comprising 2,260 12-to-15-year-olds revealed that the vaccine is 100 percent effective and well-tolerated.

The FDA's independent Vaccines and Related Biological Products Advisory Committee did not fulfill to decide on whether to propose extending the EUA to children aged 12 to 15. Even then, the Advisory Committee on Immunization Practices of the US Centers for Disease Control and Prevention is due to meet on Wednesday to counsel the CDC on whether to prescribe the vaccine for this age group. Dr. Rochelle Walensky, Director of the Centers for Disease Control and Prevention, would then determine if the vaccine should be approved for use in the new population.

Vaccinations for children aged 12 to 15 are not required to begin until after the recommendation. The Biden government has stated that it would immediately organize to prepare vaccines for children aged 12 to 15 years old through the federal pharmacy service, pediatricians, and family physicians.

Broadening permission to people aged 12 to 15 allows the COVID-19 vaccine to reach an additional 5% of the US population or about 17 million people. Because of the extended permit, 85 % of the US population is now qualified for a COVID vaccine.

Pfizer said last week that it plans to file an immediate use permit request for its COVID-19 vaccine for children aged 2 to 11 in September. It is currently conducting a vaccine safety and effectiveness trial of children aged 6 months to 11 years old.

The FDA has also called a meeting of its Vaccines and Related Biological Products Advisory Committee for June 10 to explore the possibility of extending EUA to children under the age of 12.

"During the conference, the FDA will have an update on our approach to emergency use authorization (EUA) for COVID-19 vaccines intended for use in persons 12 to 17 years of age," the FDA said in a statement.

"The committee may go through the documentation that will be required to approve a EUA and a biologics license application (BLA) for a COVID-19 vaccine intended for use in children under the age of 12. No relevant products will be discussed by the committee.

Vaccines manufactured by Moderna and Johnson & Johnson are officially approved to be used in people aged 18 and over.

"We agree that making vaccines available for use in the pediatric community is the next crucial move," Dr. Peter Marks, director of the FDA's vaccination branch, said in a report.

"As for the original COVID-19 vaccine authorizations, we also want to make sure the public understands our requirements for the evidence and details required to endorse demands for emergency use authorization and biologics license applications for vaccinations designed to avoid COVID-19 in this pediatric age group."

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