by Carolyn Hendler, JD, Theresa Wrangham and Marco Cáceres on
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 […]
At the height of the fear and confusion associated with the declaration of a coronavirus pandemic public health emergency and strict social distancing regulations in the spring of 2020, U.S. health officials published a report that, in 2016, autism spectrum disorder (ASD) was estimated to affect one in 54 eight-year old children in the U.S., […]
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 […]
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 […]