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 […]
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 […]
Why Is There Such Reluctance to Discuss Natural Immunity?
Opinion | If you’re among those of us who aren’t tribally invested in COVID politics but would like good information about when life will resume as normal, chances are you’re interested in herd immunity. You’re likely not interested in having to rely on the Internet Archive for good information on herd immunity. Alas, it’s become a go-to place […]
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.
With Little Safety Data, CDC Recommends Pfizer COVID Vaccine for 12-Year-Old Children
Opinion | I monitor meetings of the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC) for the National Vaccine Information Center (NVIC). On May 10, 2021, the U.S. Food and Drug Administration (FDA) expanded the Emergency Use Authorization (EUA) granted Pfizer/BioNTech to distribute its experimental mRNA vaccine in […]