BIO’s Dr. McMurry-Heath Calls on HHS Sec. Azar to Publicly Release FDA Guidance on Emergency Use Authorization for Covid-19 Vaccines
Dr. Michelle McMurry-Heath, the president and CEO of the Biotechnology Innovation Organization (BIO), released a letter today urging Health and Human Services (HHS) Secretary Alex Azar to “publicly release all new guidance developed by the Food and Drug Administration (FDA) concerning emergency use authorization for vaccines to prevent the spread of COVID-19.”
In the letter, Dr. McMurry-Heath emphasizes the importance of FDA guidance in promoting scientific rigor, transparency, and communication to help build public trust in any future vaccine related to Covid-19:
“The release of FDA guidance would provide scientists and researchers greater regulatory clarity and strengthen public confidence in any future vaccine that may be authorized or approved.
“BIO member companies are leading a global effort to develop vaccines against COVID-19… The scale and speed of the biopharmaceutical industry’s response to the novel coronavirus is unprecedented. These efforts to bring a safe and effective vaccine to the public provide real hope that this pandemic will soon end, and our nation will begin to return to normal.
“We cannot allow a lack of transparency to undermine confidence in the vaccine development process. The public must have full faith in the scientific process and the rigor of FDA’s regulatory oversight if we are to end the pandemic. Releasing any additional guidance on granting emergency use authorization for a vaccine will go a long way in accomplishing this critical goal.”
Read the full letter here.