COVID-19 Vaccine Developers to Issue Joint Public Pledge Against Premature Launch Before Proving Safety and Effectiveness

Several developers of COVID-19 vaccines are coming together to issue a public pledge against seeking government approval until their candidates prove to be safe and effective, in a move to reassure the public that they will not compromise scientific, regulatory rigor amidst the urgency to develop a coronavirus vaccine.

According to a report by The Wall Street Journal (WSJ), vaccine makers including Pfizer Inc. (New York, NY, USA), Johnson & Johnson (New Brunswick, NJ, USA) and Moderna, Inc. (Cambridge, MA, USA) are finalizing the draft of the joint statement that commits to making the safety and well-being of vaccinated people their priority. The companies will also pledge to adhere to high scientific and ethical standards in the conduct of clinical studies and in their manufacturing processes. According to the draft statement, the vaccine makers will submit applications for Emergency Use Authorization (EUA) to the US Food and Drug Administration (FDA) or licensure of vaccines based on “substantial evidence of safety and efficacy” from Phase 3 clinical trials being conducted under the FDA’s guidance.

“We believe this pledge will help ensure public confidence in the COVID-19 vaccines that may ultimately be approved and adherence to the rigorous scientific and regulatory process by which they are evaluated,” says the draft statement, as mentioned in the WSJ report.

Separately, speaking at an online press briefing organized by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Pfizer’s Chief Executive Albert Bourla said, “We will never ourselves submit for authorization or approval any vaccine before we feel it is safe and effective. We will not cut corners.”

At the IFPMA event, rival Merck’s Chief Executive Kenneth Frazier also assured that safety remained their top priority and said, “We all understand the need to move with urgency given the pandemic, but we will not sacrifice safety under any set of circumstances.”

Related Links:
Pfizer Inc.
Johnson & Johnson
Moderna, Inc.