Moderna Inc. has made all necessary submissions required by the U.S. Food and Drug Administration for emergency use authorization of the company’s COVID-19 vaccine in adolescents and children.
The U.S. Food and Drug Administration approved ViiV Healthcare’s Cabenuva (cabotegravir, rilpivirine) for the treatment of HIV-1 in virologically suppressed adolescents (HIV-1 RNA less than 50 copies per milliliter [c/mL]) who are 12 years of age or older and weigh at least 35kg on a stable antiretroviral regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.
Novavax Inc. said on February 10 the company’s two-dose vaccine was 80% effective against COVID-19 in a late-stage trial testing the shot in teens aged 12 to 17 years.
There is no evidence at present that healthy children and adolescents need booster doses of COVID-19 vaccine, the World Health Organization’s chief scientist Soumya Swaminathan said on January 18.
The U.S. Centers for Disease Control and Prevention (CDC) said on January 5 the agency expanded the eligibility of Pfizer Inc. and BioNTech SE’s booster doses to those 12 to 15 years old.
The U.S. Food and Drug Administration on January 3 authorized the use of a third dose of the Pfizer and BioNTech COVID-19 vaccine for children ages 12 to 15, and narrowed the interval for booster shot eligibility to five months from six.
The FDA granted Emergency Use Authorization (EUA) to Pfizer and BioNTech for their COVID-19 vaccine booster shots in kids ages 12 and up.
The U.S. Food and Drug Administration approved Novartis’
Cosentyx (secukinumab) for the treatment of active enthesitis-related arthritis in patients 4 years and older, and active psoriatic arthritis in patients 2 years and older.
Moderna Inc. was told that the U.S. Food and Drug Administration will require additional time to complete the regulatory agency’s assessment of the company’s Covid-19 vaccine for use in adolescents aged 12 to 17 years.
The U.S. Food and Drug Administration on Sept. 21 approved Incyte Corp.’s cream Opzelura for treating the inflammatory skin condition atopic dermatitis, commonly called eczema, in adolescents and adults with boxed warnings.