Biopharma Leaders Make Pledge to Science, Not Politics
Abigail Taylor POSTED ON SEPTEMBER 8, 2020
WASHINGTON – Biopharma leaders behind developing a COVID-19 vaccine put out a first of its kind joint pledge early Tuesday morning, in an attempt to reassure the public about their commitment to safety, not politics.
The pledge was signed by nine companies in total; including AstraZeneca, Johnson & Johnson, BioNTech, GlaxoSmithKline, Merck, Pfizer, Novavax, Sanofi, and Moderna.
The pledge reads:
We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles. The safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA). FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US. FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. Following guidance from expert regulatory authorities such as FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to:
Always make the safety and well-being of vaccinated individuals our top priority.
Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.
Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.
Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.
We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved.
The nine companies whose names are listed on the pledge are working both jointly and separately to develop a potential COVID-19 vaccine.
So far, more than 10 billion federal dollars has been poured into their work.
Their pledge came out just one day after a press conference where President Trump stated he is in close contact with heads of companies like Johnson & Johnson and Phizer as they work toward developing a COVID-19 vaccine.
“So, we’re going to have this vaccine very soon,” said President Trump, during the briefing. “Maybe even before a very special date. You know what date I am talking about.”
Some presume that President Trump is piling on the pressure in hopes to get a vaccine out before November to provide a boost toward re-election, however during the briefing, the President also claimed his only goal is to get a vaccine out by the end of the year in order to save as many lives as possible.