Former FDA Chief Stephen Hahn Joins Venture Capital Firm Behind Moderna COVID Vaccine
Stephen Hahn, MD, who served as commissioner of the U.S. Food and Drug Administration (FDA) from Dec. 17, 2019 through Jan. 20, 2021, has been hired by Flagship Pioneering Co.—the venture capital firm that launched biotechnology Moderna, Inc., maker of the experimental mRNA-1273 COVID-19 biologic currently being distributed in the United States under an emergency […]
Mandating a Novel Vaccine is a Novel Legal Issue
The emergency use authorization (EUA) granted to vaccine manufacturers by the U.S. Food and Drug Administration (FDA) to allow experimental COVID-19 vaccines to be distributed to the U.S. population states that the product is “an investigational vaccine not licensed for any indication” and requires that all “promotional material relating to the COVID-19 Vaccine clearly and […]
NIH Begins Testing Mixed COVID-19 Vaccine Schedules
The U.S. National Institutes of Health (NIH) has announced that it has begun an early stage Phase 1/2 clinical trial to examining what happens when an adult who is fully vaccinated with one type of COVID-19 vaccine, is given a different booster vaccine from another manufacturer three to four months later.1 Currently, there are three […]
Probable Link Found Between Pfizer’s COVID Shot and Heart Inflammation
On June 2, 2021, the Israeli Ministry of Health announced that it believes there is a “probable link” between Pfizer/BioNTech’s experimental messenger RNA (mRNA) BNT162b2 biologic for COVID-19 and dozens of cases of myocarditis (inflammation of the heart) in Israel—mostly in males between 16-30 years of age. According to an epidemiological study undertaken by a […]
OSHA Revises Employer Guidelines on COVID Vaccine Reactions to Avoid “Appearance” of Discouraging Vaccination
As an increasing number of employers including restaurants, colleges and health care facilities are requiring the COVID-19 vaccine, many employers are looking to the federal Occupational Safety and Hazard Administration (OSHA), among other government agencies, for guidance on how to proceed with COVID-19 vaccination protocols.
Experimental COVID-19 Vaccine Being Tested on Babies
Story Highlights An eight-month-old baby is the youngest person in the world to have been fully vaccinated with two doses of Pfizer’s experimental COVID-19 vaccine. The Centers for Disease Control and Prevention had previously granted Emergency Use Authorization (EUA) of the experimental COVID vaccines for use in adults and has recently expanded its authorization to […]
