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FDA Approves BioNTech’s Comirnaty. Pfizer COVID Shot Remains Experimental.

BioNTech's Comirnaty biologic

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 […]

So What Happens if You Get Injured by a COVID-19 Vaccine?

jar of cash with a band-aid

Opinion | The experimental COVID-19 vaccines are being released first to a designated group of health care workers and residents of senior living facilities. As more of the vaccines becomes available, people at high-risk to the SARS-CoV-2 virus due to their medical conditions will be given an opportunity to get vaccines. Finally, the general public […]

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 […]

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