[Docket No. FDA-2020-N-1898]
News coverage of Sarah's testimony:
My name is Sarah Christopherson. I am the Policy Advocacy Director at the National Women’s Health Network, a nonprofit advocacy organization that has been bringing the voices of women to the FDA for 45 years. We are supported by our members and do not accept financial support from drug or device makers. I have no conflicts of interest to disclose.
As we heard in the powerful Reagan-Udall presentation this afternoon, there is a larger socio-political context for today’s meeting. The ramifications mean you must go above and beyond before recommending an EUA.
As noted in several presentations, distrust of even widely used vaccines predates the pandemic and has only grown this year. Meanwhile, the president of the United States has promoted unproven “miracle” cures and dangerous theories for partisan gain. Added to that volatile mix, FDA has made serious missteps this year.
And while we recognize that FDA resisted short-cutting the collection of follow-up data in the face of significant external political pressure, much damage has already been done to the public’s faith in federal scientific integrity. This committee must play a strong role in reassuring the public that the vaccine is safe and effective.
Otherwise, the damage could ripple through public health for decades.
Relatedly, while the guidance “strongly encourages” clinical trial enrollment of the populations most affected by COVID-19, we urge this committee to go further and not recommend an EUA until there’s sufficient data to demonstrate that the vaccine works in those groups who are most affected.
As noted today, Black, Latinx, Indigenous, and other people of color have faced high and disproportionate infection and mortality rates. They’ve also expressed a strong interest in knowing that the vaccine will work in people like them. Yet they are significantly underrepresented in COVID-19 vaccine trials and there’s no guarantee that they will be included in case-driven interim analyses.
Determining safety and efficacy in a clear and compelling manner must mean more than simply reaching a sufficient number of total cases. The sponsors’ protocols indicate that they will take an interim look at the effectiveness of their vaccines at 31 or 53 cases. While that might be enough to demonstrate that a vaccine is effective overall, we believe that the committee should ask for more. Do those cases show that the vaccine is effective in women? In people of color? In older adults?
No matter how many cases have occurred in the vaccine trials when the committee is finally asked to weigh in on a sponsor’s data, communities of color, women, and older adults must have confidence that vaccines work for people like them. We’re counting on you to send a strong message to the FDA.
Thank you for your consideration.