Published June 6, 2022
On June 6, 2022, EPPC Fellow David Gortler submitted a public comment to the Food and Drug Administration on a public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee to discuss an Emergency Use Authorization (EUA) request by Novavax for a vaccine to prevent COVID-19 in individuals 18 years of age and older.
In the comment, Dr. Gortler explains that “the Novavax vaccine should not be granted an EUA because there is no emergency necessitating the emergency approval process and the vaccine trials show evidence of serious risk of heart inflammation.”
Click here to view a PDF of the comment.