Pallone on FDA’s Standards for COVID-19 Vaccine Approval
Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) released the following statement today on the Food and Drug Administration’s (FDA) guidance to pharmaceutical manufacturers on its review standards for a future Emergency Use Authorization of a COVID-19 vaccine:
“I’m relieved to see FDA taking action to ensure that patient safety and scientific evidence of efficacy will guide the agency’s review of potential COVID-19 vaccines.
“Yesterday, President Trump attempted to block FDA from issuing further guidance related to the Emergency Use Authorization of a vaccine citing objections from the manufacturers developing potential COVID-19 vaccines. Today, my office spoke to representatives from Johnson & Johnson, Merck, Moderna, Novavax and Pfizer and each of the companies indicated that they did not lobby the White House against FDA’s guidance and that they are supportive of public release of the agency’s guidance.
“Looking forward, FDA must be allowed to fulfill its mission to protect public health by ensuring the safety, efficacy and trust of any future COVID-19 vaccine. Any attempt by President Trump to override FDA or compel manufacturers to prematurely bring a vaccine to market will do catastrophic harm to our nation’s health and security and permanently undermine the trust of the American people in a future vaccine.”