The U.S. Food and Drug Administration authorized Pfizer and BioNTech’s Covid-19 vaccine for use in children as young as 12, widening the country’s inoculation program as vaccination rates slowed significantly. Reuters provided information that should help parents decide whether to inoculate their adolescent children.
The U.S. Food and Drug Administration is preparing to authorize Pfizer Inc. and German partner BioNTech SE’s Covid-19 vaccine for adolescents aged between 12 and 15 years by early next week, the New York Times reported on May 3, citing federal officials familiar with the regulatory agency’s plans.
The U.S. Food and Drug Administration approved ALK Inc.’s Ragwitek (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use for the treatment of short ragweed pollen-induced allergic rhinitis in persons ages 5 through 65 years old.
Pfizer Inc. and the company’s German partner BioNTech SE on April 9 asked U.S. regulators to allow the emergency use of their vaccine in adolescents aged 12 to 15 years old.
Pfizer Inc. said on April 7 the U.S. Food and Drug Administration extended the review of the company’s experimental atopic dermatitis drug by three months, the latest regulatory setback for a class of treatments known as JAK inhibitors.
Pfizer and BioNTech on March 31 announced data from a Phase III study which showed 100 percent efficacy and robust antibody responses in patients ages 12-15 years old who received the BNT162b2 vaccine.
Moderna Inc. dosed the first participants in a mid-to-late stage study testing the company’s Covid-19 vaccine candidate in adolescents aged 12 to less than 18, and aims for data ahead of the 2021 school year.
Pfizer received approval from the U.S. Food and Drug Administration to enroll children as young as 12 years of age in the company’s Covid-19 vaccine trial.
Europe’s healthcare regulator endorsed using dexamethasone to treat Covid-19 patients with breathing difficulties, paving the way for the steroid to become the region’s second approved treatment for the respiratory illness.
Sinovac Biotech plans to start a clinical trial of the Chinese vaccine maker’s experimental coronavirus vaccine with children and adolescents in September, widening the company’s test on a shot that is already in the final stage of study with adults.
