The director of the U.S. Centers for Disease Control and Prevention (CDC) signed off on the U.S. Food and Drug Administration’s full approval of Moderna Inc.’s COVID-19 vaccine in those aged 18 and over, the agency said on Feb. 4.
The U.S. Food and Drug Administration on Jan. 31 gave full approval to Moderna Inc.’s COVID-19 vaccine for people ages 18 and older, making Spikevax the second fully approved vaccine for the virus.
U.S. health regulators could approve a third Covid-19 shot for adults beginning at least six months after full vaccination, instead of the previously announced eight-month gap, the Wall Street Journal reported on Aug. 25.
Moderna Inc. completed the real-time review process needed for a full approval for the company’s Covid-19 vaccine in people aged 18 years and older.
Formal U.S approval of the Pfizer Inc./BioNTech SE Covid-19 vaccine will make it nearly impossible to successfully challenge mandates by employers, legal experts said.
The United States could get Covid-19 under control by early 2022, with potential wider vaccine approvals coming in the weeks ahead, Dr. Anthony Fauci said one day after Pfizer won wider FDA approval for the company’s novel coronavirus shot on Aug. 23.
New York City will require public school teachers and staff to get vaccinated against Covid-19, Mayor Bill de Blasio said on Aug. 23, part of a push to get more residents inoculated and slow the spread of the highly contagious Delta variant.
The U.S. Food and Drug Administration granted the Pfizer-BioNTech Covid-19 vaccine Comirnaty full approval.
The U.S. Food and Drug Administration granted Seagen Inc. and Astellas Pharma Inc.’s Padcev (enfortumab vedotin-ejfv) regular approval in the United States, in addition to approving a new indication for adult patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.
Moderna Inc. on June 1 filed for full U.S. approval of the company’s Covid-19 vaccine, becoming the second drugmaker to do so after Pfizer Inc. and its German partner BioNTech SE sought full clearance for their vaccine in May.
