December 11, 2020
FOR IMMEDIATE RELEASE
Contact: Adele Costa, email@example.com
Yesterday, the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee voted 17-4-1 to recommend emergency use authorization of the COVID-19 vaccine developed by Pfizer/BioNTech. Soon after, the FDA announced its intent to grant that authorization quickly, possibly as soon as today. Such authorization would permit the vaccine’s immediate distribution to high priority recipients around the country, including health care workers and long-term care residents.
While the National Women’s Health Network applauds the FDA’s diligent work on vaccines during this public health emergency, we have serious concerns that the efficacy and safety data submitted by Pfizer/BioNTech for FDA’s review failed to include enough vaccine recipients from some of the communities that have been hardest hit by the virus.
Yesterday, Sarah Christopherson, Policy Advocacy Director for the NWHN, testified before the panel that the scarcity of key data will do little to assuage legitimate concerns in those communities about taking the vaccine.
Pew Research 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.
While the NWHN stopped short of urging the panel to vote no — in recognition of the strong data submitted for women, seniors, and other communities that have been devastated by the coronavirus, including the Latino community — Christopherson urged the FDA to “ensure robust tracking and public transparency once the vaccine is taken at scale,” noting the possibility for “further fuel[ing] distrust among communities that have been given little reason to trust this process.”
The NWHN believes that transparency now and going forward is key, and urges the FDA to keep the public informed about the vaccine’s safety, efficacy, and side effects as it is distributed at scale. Further, we urge other vaccine sponsors seeking authorization to submit data for all deeply impacted populations. Rushing forward with data that leaves Black and Indigenous people without assurances about what the vaccine will mean for them will, in our estimation, further damage the public trust in this process, thereby hindering efforts to control this virus.