Health News

FDA authorizes another COVID-19 at-home test

Fox News Flash top headlines for October 5 Fox News Flash top headlines are here. Check out what’s clicking on Foxnews.com. The U.S. Food and Drug Administration (FDA) announced Monday that it had issued an emergency use authorization for the ACON Laboratories Flowflex COVID-19 Home Test. The over-the-counter (OTC) COVID-19 antigen test will be added […]

Health News

Pfizer sends first data to FDA on COVID vaccines for younger kids

(HealthDay)—Pfizer Inc. announced Tuesday that it has submitted initial data to federal regulators on the efficacy of its COVID-19 vaccine among younger children. The company is also expected to submit the same data on kids aged 5 to 11 to the European Medicines Agency and other regulatory authorities in the next few weeks, CNN reported. […]

Health News

FDA experts among group opposing US booster shot plan

The average person doesn’t need a COVID-19 booster yet, an international group of scientists—including two top U.S. regulators—wrote Monday in a scientific journal. The experts reviewed studies of the vaccines’ performance and concluded the shots are working well despite the extra-contagious delta variant, especially against severe disease. “Even in populations with fairly high vaccination rates, […]

Health News

Companies Seek EUA for New COVID Monoclonal Antibody Treatment

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. An independent data monitoring committee is recommending stopping enrollment of a phase 3 trial of a monoclonal antibody for COVID-19 because interim results indicate an 85% (P = .002) reduction in hospitalizations or death, two companies have announced. Vir Biotechnology and […]

Health News

Why Are Vaccines Still in Short Supply?

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Boxes containing the Pfizer-BioNTech covid-19 vaccine are prepared to be shipped at the Pfizer Global Supply Kalamazoo manufacturing plant. The U.S. government has invested billions of dollars in manufacturing, used a wartime act dozens of times to boost supplies and yet […]

Health News

Trials of retooled vaccines for variants could take months: U.S. FDA

(Reuters) – Drugmakers should test any COVID-19 vaccines that have been retooled to combat new variants of the coronavirus in clinical trials designed to track the immune response of hundreds of test subjects, which could take months, U.S. regulators said on Monday.Slideshow ( 3 images )Vaccine developers may need to modify their shots to provide […]

Health News

FDA Review Finds Pfizer COVID-19 Vaccine Effective After First Dose

TUESDAY, Dec. 8, 2020 — New data released Tuesday by the U.S. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee suggest that Pfizer’s two-dose COVID-19 vaccine works well protecting recipients against COVID-19. The committee is scheduled to meet on Thursday to consider the Pfizer/BioNTech COVID-19 vaccine for emergency use authorization, CNBC reported. […]