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 […]
by Vicky Pebsworth, PhD, RN and Theresa Wrangham on
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 […]
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 […]
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 […]