Given the rapid development of vaccines racing to provide immunity to Covid-19, there is an equal urgency for heightened scientific scrutiny of the data needed to confirm efficacy and safety. For the leaders in women’s health, there is a need to know: Are these trials examining the sex differences in outcomes—meaning, will we know if women respond similarly to men with regard to dosing and side effects of these vaccines? The query has been an ongoing issue in research for decades aimed at having every clinical trial recruiting participants in sufficient numbers to be able to analyze data for sex differences and report any variations. This is necessary if we are to achieve the best outcome for every patient.
These concerns have been elevated following release of preliminary data from Moderna,1 published in the New England Journal of Medicine, as well as Pfizer and BioNTech, in which both men and women participated in early studies on these vaccines under development but for which there are no results shared on responses to the vaccine based on patients’ sex.
An article in Modern Healthcare,2 addresses this omission—the failure to analyze the data for sex differences—through interviews with leading expert’s in women’s health, including commentary from Kim Templeton, MD, the first Joy McCann Professor of Women in Medicine and Science at the University of Kansas School of Medicine in Lawrence, and a founding member of the Sex and Gender Health Collaborative, an initiative of the American Medical Women’s Association (AMWA).
There is still much work to do; and you can be part of the change. Consider joining the Sex and Gender Health Collaborative.
- Jackson LA, Anderson EJ, Rouphael, et al, for the mRNA-1273 Study Group. An mRNA Vaccine against SARS-CoV-2 — Preliminary Report. N Engl J Med. 2020; ahead of print. Available at: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2022483?articleTools=true. Accessed August 3, 2020.
- Castellucci M. COVID vaccine trials must weight effects on both men, women researchers say. August 1, 2020. [Subscription required]. Modern Healthcare. August 1, 2020. htpps://www.modernhealthcare.com/safety-quality/covid-vaccine-trials-must-weigh-effects-both-men-women-researchers-say. Accessed August 2, 2020.