[Docket No. FDA-2020-N-1898]

STATEMENT:

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.

We applaud FDA for their diligent work during this public health emergency on desperately needed vaccines.

However, we have serious concerns that moving forward with an emergency use authorization based on so little data for many of the communities that have been hardest hit by the virus will do little to assuage legitimate concerns in those communities about taking the vaccine.

As we heard this morning, CDC data indicate that Black and Indigenous people living in the US are roughly 4 times more likely to be hospitalized from Covid-19 and roughly 3 times more likely to die from the virus than their white counterparts. Racism—both systemic and interpersonal—health care disparities, and increased workplace exposure are all factors. As a result, Pew found that 71% of Black Americans know someone who has been hospitalized or died because of Covid-19, compared to just 49% of white Americans. Similarly, Black respondents expressed higher rates of being “very” or “somewhat” concerned about contracting Covid-19 than their white counterparts.

As we heard at the October 22 meeting, they have also expressed a strong interest in knowing that the vaccine will work in people like them. Without those assurances, Black Americans have expressed high rates of Covid vaccine hesitation, and for good reason. Black Americans don’t have to look back to the last century or to the infamous Tuskegee Study to see examples of the medical system undervaluing them. Many Black and Indigenous people have had multiple discriminatory and negative experiences with the medical system in their own lives.

In its research into vaccine acceptance, Pew found a clear link between confidence in the research, development, and approval process and Americans’ willingness to get the vaccine. Before authorization is granted, affected communities need to have confidence that the vaccine is safe and effective for people like them.

The efficacy data submitted to this panel included fewer than 2,000 “Black or African American” vaccine recipients and just 131 “American Indian or Alaska Native” recipients—not counting the placebo control population. The safety data included just 206 Black seniors aged 65 or older and just 101 American Indian or Alaska Native people of any age.

If this advisory committee votes to recommend authorization based on this data, FDA must ensure robust tracking and public transparency once the vaccine is taken at scale. Otherwise, the significant near-term side effects of the vaccine—such as fever, chills, pain, and fatigue, all of which could be quite alarming to the public—could further fuel distrust among communities that have been given little reason to trust this process.