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