Dr. Michelle McMurry-Heath, the president and CEO of the Biotechnology Innovation Organization (BIO), today applauded the Food and Drug Administration (FDA) for publicly releasing new guidance related to the emergency use authorization of future Covid-19 vaccines. The FDA’s action came just days after Dr. McMurry-Heath called on U.S. Health & Human Services Secretary Alex Azar to release the guidance in order to help those developing a vaccine and to promote greater public confidence in future Covid-19 vaccines. Dr. McMurry-Heath released the following statement:
“In the midst of a pandemic, transparency and collaboration are critical if we are going to quickly and safely eradicate this global health threat. That is why we recently called for the public release of any new FDA guidance concerning emergency use authorization for Covid-19 vaccines. The release of this information is vital for the scientists and researchers working on the frontlines combating this pandemic, as well as for building public confidence in the scientific solutions our industry is committed to delivering.
“We applaud the FDA for following their tried and true tradition of releasing their guidance in a public and transparent way. Science should stand on its own. While we are still reviewing the details, this is an important step forward in providing greater regulatory clarity for vaccine makers and in earning the American people’s trust in any future vaccines. We look forward to ongoing communication with the independent experts at the FDA to further clarify the steps needed to bring a safe and effective vaccine to the American public.”