New Hep B Vaccine: The Good, the Bad, and the Ugly

On November 9, 2017, the FDA approved for use a new hepatitis B vaccine HEPLISAV-B.

The good news is twofold. First, efficacy was higher in a head-to-head trial with EnergIx-B, 95% versus 81%, a statistically significant difference in a trial involving about 10,000 participants. Second, the new vaccine is a two-dose series with the second dose given 1 month after the first. The three-dose series for the other two approved hepatitis B vaccines each take six months to complete. The more doses in a vaccine series and the longer the time interval between the first and last dose, the lower the completion rate for the series and the longer the intervals of undervaccinated status.

According to a study done over an 8-year period, what percentage of adults fail to complete the current three-dose hepatitis B series of vaccines within 12 months?

A. 10%

B. 25%

C. 50%

D. 70%

Please click "next" for answer and discussion.

The correct answer is C. 50%

Given the above information, the new vaccine, made with a different adjuvant, looks like a clear winner over the older vaccines. Adjuvants are compounds, often proprietary, added to the vaccine to boost the immune response and some presumably work better than others.

Now for the bad news:  some safety concerns have been raised over a larger number of deaths and heart-related problems in the group receiving the new vaccine vs the control group that received Energix-B. The overall rate of myocardial infarction in both groups was small, but higher with HEPLISAV-B as compared to Engerix-B, 0.3% vs 0.1%. In a non-unanimous vote, the FDA approved the use of HEPLISAV-B in persons over age 18 with the proviso that ongoing monitoring be done by the manufacturer Dynavax.

And, the ugly news:  hepatitis B continues to be a problem in the United States with more than 19,000 new cases in 2014 and perhaps currently as many as 2 million Americans living with chronic hepatitis B. Rates have dropped dramatically since children began receiving the vaccine  routinely in 1991. But, in 2015 rates went up about 20% over the previous year.

It will be interesting to see what the CDC thinks of this new vaccine when its Advisory Committee on Immunization Practices meets next. Will they recommend its use over the older vaccines despite the safety concerns?  Stay tuned.

For extra credit:  Can you name the three cinematic icons who represented the “Good,” the “Bad,” and the “Ugly” in the movie of the same name, released in the United States in 1967? 

Please click "next," below, for answer and resources

Answer: Clint Eastwood (good), Lee Van Cleef (bad), and Eli Wallach (ugly) played the three characters. "A Fistful of Dollars" and "For a Few Dollars More" were the other two films in this “spaghetti western" trilogy staring Eastwood and that catapulted him to fame.

Resources

Centers for Disease Control and Prevention. Viral Hepatitis. Hepatitis B FAQs for the Public.

Centers for Disease Control and Prevention. Hepatitis statistics, 2015 Surveilance.

Bittner RCL, Bounds L, et al. Compliance with multiple-dose vaccine schedules among older children, adolescents and adults: results from a Vaccine Safety Datalink Study. American Journal of Public Health. 2009;99:S2.

Dynavax announces FDA approval of HEPLISAV-B(TM) for prevention of hepatitis B in adults [press release]. Berkley: Dynavax Technologies Corporation; November 9, 2017.