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FDA: Moderna Vaccine Safe for Kids 6 Months to 17 Years

U.S. Food and Drug Administration advisers say Moderna’s COVID-19 vaccine is safe and effective for children aged 6 months to 17 years, according to an FDA document made public on Friday. Two doses of the Moderna vaccine caused an immune response in clinical trial participants that was similar to the immune response […]

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La FDA aprueba la primera dosis de recuerdo para los de 5 a 11 años

Con fecha 17 de mayo, la Food and Drug Administration de los Estados Unidos (FDA) ha concedido la autorizado de uso en emergencias de la vacuna Comirnaty en niños de cinco a once años, siempre que hayan transcurrido al menos cinco meses desde la recepción de las dosis de primovacunación con la […]

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FDA Authorizes COVID Booster for Younger Kids

A third dose of Pfizer/BioNTech’s COVID-19 vaccine is authorized for kids ages 5 to 11 years, the FDA announced on Tuesday. The third 10 μg dose may be administered to children at least 5 months after the initial primary series under the terms of the emergency use authorization (EUA), the agency […]

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Coronavirus (COVID-19) Update: FDA Approves First COVID-19 Treatment for Young Children

Today, the U.S. Food and Drug Administration expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct SARS-CoV-2 viral testing, who are: Hospitalized, or Not hospitalized and have […]

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Coronavirus (COVID-19) Update: FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals

Today, the U.S. Food and Drug Administration authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals. The FDA previously authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series. This action […]

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FDA to Consider Future of COVID Booster Doses

The FDA today announced its vaccines advisory committee will meet April 6 to discuss the future of COVID-19 booster doses and how to tell if a specific strain of the coronavirus needs its own vaccine. The independent experts on the Vaccines and Related Biological Products Advisory Committee will be joined by representatives […]

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FDA Committee Recommends 2022–2023 Influenza Vaccine Strains

The US Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee has chosen the influenza vaccine strains for the 2022–2023 season in the northern hemisphere, which beginnings in the fall of 2022. On March 3, the committee unanimously voted to endorse the World Health Organization’s (WHO’s) recommendations as to which influenza […]

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Coronavirus (COVID-19) Update: FDA Authorizes New Monoclonal Antibody for Treatment of COVID-19 that Retains Activity Against Omicron Variant

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for a new monoclonal antibody for the treatment of COVID-19 that retains activity against the omicron variant. The EUA for bebtelovimab is for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age […]

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