Claims for Injury, Death from COVID Shots Surge
Opinion | The Countermeasures Injury Compensation Program (CICP) is a program of the U.S. government that provide financial compensation for people who have suffered serious injuries or death from vaccines, biologics, antivirals or other drugs, as well medical devices used to “diagnose, prevent or treat a declared pandemic, epidemic or security threat.” The program was […]
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 […]
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 […]
Dentists, Optometrists, Podiatrists Can Now Administer COVID-19 Vaccines in the U.S.
The U.S. Department of Health and Human Services (HHS) has announced that the agency is amending an emergency declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to authorize additional medical professionals to administer experimental COVID-19 vaccines being distributed under an Emergency Use Authorization (EUA).1 2 This announcement was made after President Biden […]
2005 PREP Act and 1986 Act Shield Vaccine Manufacturers from Liability
Story Highlights Most countries that have supply contracts with AstraZeneca have granted the drug company liability protection for their COVID-19 vaccine. In the U.S., vaccine manufacturers and administrators are shielded from liability under the PREP Act of 2005 for a vaccine or drug that is developed in response to a declared public health emergency, including […]