FDA’s Expert Panel Recommends COVID-19 Booster Dose for Seniors and Others, Rejects Booster Dose for Children

FDA’s Expert Panel Recommends COVID-19 Booster Dose for Seniors and Others, Rejects Booster Dose for Children

Despite not convening the Vaccines and Related Biologic Products Advisory Committee (VRBPAC) last month to vote on effectiveness and safety of the Pfizer-BioNTech COVID-19 vaccine (licensed under the name COMIRNATY), the U.S. Food and Drug Administration (FDA) convened the advisory committee on Friday, Sept. 17, 2021 to vote on booster doses of the vaccine.1 The […]

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

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 […]

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

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

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

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 […]