FDA has revised the Emergency Use Authorization (EUA) for Pfizer’s (NYSE:PFE) Paxlovid (nirmatrelvir and ritonavir) to allow state-licensed pharmacists to prescribe the drug to some patients with a high risk of COVID-19. While the move allows pharmacists to prescribe Paxlovid, it has limits. It instructs the professionals to refer patients to a physician if there is insufficient…
FDA denies EUA for COVID-19 indication of SSRI fluvoxamine
The infectious disease physician-scientist Dr. David R Boulware filed for the emergency use authorization (EUA) of fluvoxamine, an established selective serotonin reuptake inhibitor (SSRI) whose brand name is Luvox. The FDA has rejected the application, explaining the COVID-19 treatment benefit of the drug was “not persuasive” in the TOGETHER study that was the basis of the…
Pfizer and BioNTech file for EUA for COVID-19 vaccine booster in kids 5 to 11
Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have filed an application with the FDA for emergency use authorization (EUA) for a 10-µg booster dose of their BNT162b2 COVID-19 vaccine in children aged 5 to 11. The companies included data in the application from a Phase 2/3 study that tested a booster dose in children between…
U.S. could announce COVID-19 vaccine booster plan in early September
In response to the largest coronavirus spike in infections in months, the FDA is prepping a plan for COVID-19 vaccine boosters. The plan will likely follow other guidelines by prioritizing boosters for immunocompromised and elderly individuals, according to a report from WSJ. The U.K., Germany and Israel have recommended providing boosters to high-risk populations. The growing support of…