Thank you for the opportunity to speak today. My name is Dr. Megan Polanin. I am a Senior Fellow at the National Center for Health Research. Our research center analyzes scientific and medical data and provides objective health information to patients, providers, and policymakers. We do not accept funding from industry, so I have no conflicts of interest.
Like any public health strategy, a vaccine’s benefits must outweigh the risks. One of the major benefits of Heplisav-B is that the shorter dosing schedule could improve vaccination rates. However, the clinical trials have raised serious concerns about safety for some patients.
We commend the FDA for closely analyzing the safety data, and agree that the effect on adverse events is unclear. We support the FDA’s diligence in working with the company to develop future studies needed to address these safety concerns.
We commend the company for including more Black patients in HPV-16 and HPV-23 as this group has a relatively high incidence of acute hepatitis-B infection. However, Asians living in the United States account for more than half of the one million Americans living with chronic hepatitis B. Chronic infection is responsible for most HBV-related morbidity and mortality.
Clearly, Asians are not adequately represented in the company’s pivotal trials. There is no way to know if the impact of the vaccine would be different for any Asian groups, because too few Asians are included in the study.
In addition, the clinical trials took place in different countries with varying numbers of patients with diabetes, high BMI, or a history of smoking. These factors could also affect the risk/benefit ratio.
We feel for the company because it has previously tried and failed to obtain approval. However, the bottom line is we don’t know how safe the vaccine is overall, and specifically how safe it is for Asians, who comprise the majority of patients living with chronic Hepatitis B. It is better for FDA to be cautious rather than approve a potentially dangerous vaccine – especially because other options are available.
We strongly urge this Advisory Committee to prioritize patient safety and urge the FDA to maintain its scientific safety standards for approval and therefore recommend additional pre-licensure studies to further evaluate the safety of Heplisav-B in subpopulations who are disproportionately affected by both acute and chronic hepatitis-B infection.
References
Centers for Disease Control and Prevention (2017, June 19). Surveillance for Viral Hepatitis – United States, 2015. Retrieved from https://www.cdc.gov/hepatitis/statistics/2015surveillance/index.htm
Centers for Disease Control and Prevention (2016, August 30). Asian Americans and Pacific Islanders and Chronic Hepatitis B. Retrieved from https://www.cdc.gov/hepatitis/populations/api.htm
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 11-1, with 3 abstentions, in favor of approval of Heplisav-B. Read more about the meeting here.