Encouraging words

 

Thank you so much to the many of you who have reached out to me with lovely messages about our celebration of Maya a few days ago.

And while we are on the subject of encouraging words, I was pleased to see the following announcement from Pfizer.

The CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi, have made a historic pledge to the world, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential regulatory filings and approvals of the first COVID-19 vaccines.

All nine CEOs signed the following pledge:

 

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.

One of the concerns I and many others have had is that, in the current environment, many people will not trust any vaccine that will be developed despite assurances that it is both safe and effective. There is perhaps understandable, albeit in my mind unwarranted, concern that pharmaceutical companies and the Food and Drug Administration will be pressured to approve a vaccine before its safety and efficacy have been clearly demonstrated. I hope this statement from the major players will go some distance in reassuring the public that the science is sound and that this will result in sufficient numbers of people trusting the development process so that use of the vaccine will be as widespread as it will clearly need to be to return our lives to some form of normalcy.

Love,

Rebecca