FDA Approves BioNTech’s Comirnaty. Pfizer COVID Shot Remains Experimental.
On Aug. 23, 2021, the U.S. Food and Drug Administration (FDA) gave full approval to a Biologics License Application (BLA) submitted by BioNTech Manufacturing GmbH of Mainz, Germany on May 18, 2021 for a biologic drug called COVID Vaccine, mRNA. The FDA gave permission to BioNTech to label the product “Comirnaty” and market it in […]
NFL Tackles Polarizing New COVID-19 Vaccine Rules Restrictions
The National Football League (NFL) has announced they will enforce strict new COVID vaccination, masking and testing rules this football season due to the availability of experimental COVID-19 vaccines, which are currently being distributed under an Emergency Use Authorization (EUA) granted by the U.S. Food and Drug Administration. The NFL lost an estimated three to […]
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 […]
CDC Intentionally Undercounting COVID-19 “Breakthrough Cases” in Vaccinated Persons
When the U.S. Centers for Disease Control and Prevention (CDC) relaxed its mask-wearing guidelines on May 13, 2021, it assured Americans, “The science is clear: If you are fully vaccinated, you are protected, and you can start doing the things that you stopped doing because of the pandemic.” But that assurance should be accompanied with […]
No More Masking?
The U.S. Centers for Disease Control and Prevention (CDC) has updated its COVID-19 guidance on wearing masks. On May 13, 2021, the CDC announced that “fully vaccinated people no longer need to wear a mask or physically distance in any setting, except where required by federal, state, local, tribal, or territorial laws, rules, and regulations, […]
U.S. Government Partnering With Community Leaders to Increase COVID-19 Vaccine Uptake
The U.S. Department of Health and Human Services (HHS) has proposed an initiative called “The