Nine vaccine makers have signed an unprecedented pledge to conduct the search for a Covid-19 vaccine only “in accordance with high ethical standards and sound scientific principles,” in an attempt to bolster public confidence in any vaccine that emerges.
Political interference with science has been evident in the US from the start of this pandemic, and public confidence that vaccine development will be guided strictly by the science is low. Many fear an October surprise in which the current administration forces authorization of a vaccine before election day on November 3.
None of the news stories I saw this morning linked to a copy of the actual pledge (here is one source), so I have reproduced it below. The signatory companies are:
Johnson & Johnson
Merck (known as MSD outside the United States and Canada)
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.
Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.
[ Note added 2020-09-08: ] The biotech trade group Biotechnology Innovation Organization also issued an open letter, on September 3. They warned that the “FDA should maintain its historic independence as the gold-standard international regulatory body, free from external influence.”