[Docket No. FDA-2021-N-0173]

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 believe that an emergency use authorization based on the data presented this week is appropriate under the current circumstances. A one-dose vaccine efficacious in preventing severe disease, including against several known variants, that can be stored for three months at normal refrigeration temperatures with fewer logistical constraints has the potential to markedly reduce hospitalizations and deaths.

With two authorized vaccines currently on the market, we now have real-world data about how logistical challenges in distribution have hampered equitable access. The Janssen vaccine represents a big leap forward for access, particularly in low-income, rural and other underserved communities.

However, because it’s difficult to make an apples-to-apples comparison between vaccines authorized based on data collected before new variants are believed to have been in widespread circulation and today’s data, there is a significant concern that headline numbers are already leading to a sense among the public that there are first- and second-class vaccines, with the latter relegated to low-income, rural, or otherwise marginalized communities. That has the potential to exacerbate existing mistrust. Public health authorities must address these perceptions head-on.

Secondly, and as we have heard in previous meetings of this committee, 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.

When examining today’s clinical trial data, we see that the data for racial and ethnic groups track closely with each group’s share of the US population but do not account for the disproportionate impact of the pandemic on different communities. Given that disparity of impact — which was already well-established at the time that trials were begun — the sponsor should have sought to enroll Black, Latino, and Indigenous participants relative to their vulnerability to the virus, not share of the total population.

Thank you for your consideration.