An effective shingles vaccine is important for public health. As patients get older, they are more likely to develop long-term pain, or post-herpetic neuralgia (PHN), as a complication of shingles. This pain can be severe and chronic. There is no cure, and treatments do not reliably relieve pain for all patients. The only way to reduce the risk of developing shingles and PHN is to get vaccinated. We urge this Advisory Committee to recommend that the FDA require critical post-approval long-term studies to further evaluate the efficacy and safety of Shingrix. We also strongly recommend that the company conduct subgroup analyses to ensure that the vaccine is safe and effective for both women and men and also people of color.

August 10, 2017. We support the efforts of the U.S. Preventive Services Task Force (USPSTF) to re-evaluate its 2012 grade “D” recommendation in light of new results from a large study, the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). This study confirmed that screening for ovarian cancer does not decrease deaths from ovarian cancer in asymptomatic women who are not known to be at high risk for ovarian cancer. Based on the USTSPF’s robust review of the literature, we agree that there is insufficient evidence to support screening for asymptomatic women.

August 9, 2017. The U.S. Preventive Services Task Force (USPSTF) last reviewed the literature in 2009 and reaffirmed their “A” grade for HBV screening for women at their first prenatal visit. We support the efforts of the USPSTF to carefully draft a research plan to guide the systematic review of available evidence for universal screening and case management programs to prevent vertical transmission of the infection as well as reduced rates of morbidity and mortality. We also endorse the efforts of the USPSTF to obtain updated information on the harms and benefits of universal screenings and case management programs for women with Hepatitis B.