Pfizer, BioNTech Get Experimental Coronavirus Vaccine ‘Fast Track’ from FDA

Pfizer and its German partner BioNTech on Monday announced two of their experimental coronavirus vaccines received Fast Track designation from the U.S. Food and Drug Administration, meaning the FDA may decide on an approval within six months. If a vaccine candidate gets the green light, the companies said they expect to make up to a […]

American Cancer Society Tells Doctors to Give Nine-Year-Old Children HPV Vaccine

American Cancer Society Tells Doctors to Give Nine-Year-Old Children HPV Vaccine

The American Cancer Society (ACS) updated its guidelines for human papilloma virus (HPV) vaccination on July 8, 2020 and now recommends that doctors and other healthcare providers routinely administer the two-dose HPV vaccination series to boys and girls between the ages of nine and 10.1 Currently, the federal Advisory Committee on Immunization Practices (ACIP) recommends […]

OB/GYN Docs in U.S. Want COVID-19 Vaccines Tested on Pregnant Women

OB/GYN Docs in U.S. Want COVID-19 Vaccines Tested on Pregnant Women

A U.S. Centers for Disease Control and Prevention (CDC) report1 on pregnancy and SARS-CoV-2 infection released on June 26 suggested that pregnant women may be at increased risk for COVID-19 complications. The report was followed by a statement issued by the American College of Obstetricians and Gynecologists (ACOG)2 urging that pregnant and lactating women be […]

The Debate Over ADHD and Doctor Prescribed Video Games

The Debate Over ADHD and Doctor Prescribed Video Games

Story Highlights There is a long-standing debate over the value versus dangers of electronic stimulation of the brain in children with attention deficit hyperactivity disorder (ADHD). Now, the Food and Drug Administration (FDA) has approved the first prescription-based video game, or “game based digital therapeutic device” for use in children with primary attention or combination […]

81 Percent of Clinical Trial Volunteers Suffer Reactions to CanSino Biologics’ COVID-19 Vaccine That Uses HEK293 Human Fetal Cell Lines

81 Percent of Clinical Trial Volunteers Suffer Reactions to CanSino Biologics’ COVID-19 Vaccine That Uses HEK293 Human Fetal Cell Lines

An experimental vaccine for COVID-19 is being developed by CanSino Biologics, Inc. of Tianjin, China, in partnership with China’s Academy of Military Medical Sciences’ Institute of Biotechnology. A Phase 1 human clinical trial of the COVID-19 vaccine (adenovirus type-5 Ad5-nCoV) has been completed in China involving 108 volunteers, ranging in age from 45–60 years old.1 […]

Israeli Woman Treated with COVID-19 “Passive Vaccine”

Israeli Woman Treated with COVID-19 “Passive Vaccine”

Hadassah Medical Center in partnership with the Israeli biotechnology company Kamada Ltd. in Jerusalem, Israel treated its first COVID-19 patient with what it described as a “passive vaccine.”1 Reportedly, a young female suffering from several underlying medical conditions, who had been hospitalized for several weeks and intubated, was passively vaccinated by injecting antibodies from a […]

Rapid Tests for Coronavirus Raise Concerns Over Accuracy

Rapid Tests for Coronavirus Raise Concerns Over Accuracy

On Mar. 27, 2020, the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) to pharmaceutical and medical devices company Abbott Laboratories, Inc. of Abbott Park, Illinois for a rapid diagnostic test for the SARS-CoV-2 virus known as ID NOW.1 2 3 “We know how important it is to get point-of-care tests out […]

Anti-Depressants in Short Supply During COVID-19 Lockdowns

Anti-Depressants in Short Supply During COVID-19 Lockdowns

Drug shortages listed by the U.S Food and Drug Administration (FDA) are exposing some of the ramifications of responses to the COVID-19 pandemic, including state lockdowns and social distancing regulations.1 Zoloft (sertraline hydrochloride), an anti-depressant manufactured by Pfizer and its generic counterparts produced by other drug makers, have been added to the FDA’s list of […]

Allergy Risks Increase as FDA Changes Food Labeling Requirements During COVID-19 Pandemic

Allergy Risks Increase as FDA Changes Food Labeling  Requirements During COVID-19 Pandemic

Opinion | On May 22, 2020, the U.S. Food and Drug Administration (FDA) issued a public comment providing new guidance that will relax the labeling requirements on packaged food to allow food companies more flexibility during the COVD-19 pandemic. Companies selling food are now allowed to make minor changes to the formulation of food products […]

COVID-19 Vaccine Will Likely Be Given Multiple Times, Perhaps Annually

COVID-19 Vaccine Will Likely Be Given Multiple Times, Perhaps Annually

In an interview with the JAMA on June 2, 2020, Anthony Fauci, MD, director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID) said that while he was “cautiously optimistic” about the effectiveness of the vaccines being developed for COVID-19, he was concerned that any protection the vaccines may provide might only be temporary. […]

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