FDA Approves PreHevbrio: First 3-Antigen Hepatitis B Vaccine For Adults
Key takeaways:
PreHevbrio is a hepatitis B vaccine that protects adults against all known subtypes of the hepatitis B virus. It’s the first to target three antigens (surface proteins) on the virus.
PreHevbrio is FDA-approved for adults age 18 or older. It’s a muscle injection that consists of three total doses.
This vaccine should be available in the U.S. by March 2022.
In late November 2021, the FDA approved a new vaccine — PreHevbrio (hepatitis B vaccine, recombinant) — to prevent hepatitis B in adults. Hepatitis B is a liver infection that’s caused by the hepatitis B virus (HBV).
Hepatitis B vaccines aren’t a new concept. In fact, over 1 billion hepatitis B vaccine doses have been given globally. But PreHevbrio is unique. It targets more HBV antigens (surface proteins) than other hepatitis B vaccines.
Even though other hepatitis B vaccines are available, hepatitis B is still a problem. HBV continues to infect between 1 and 2 million people every year around the world. PreHevbrio is another vaccine option that has the potential to improve our defenses against this serious infection. And although PreHevbrio is now approved in the U.S., it’s been available in Israel for more than 20 years.
Here, we’ll talk about PreHevbrio — what it is, how it works, and why its approval is important.
What is PreHevbrio?
PreHevbrio is a newly-approved hepatitis B vaccine. It’s approved for adults 18 and older. It’s the only hepatitis B vaccine that targets three HBV antigens.
And PreHevbrio’s approval has convenient timing. A few weeks before its approval, a Centers for Disease Control and Prevention (CDC) expert panel recommended that all U.S. adults should receive a hepatitis B vaccine. The CDC still needs to accept this recommendation, but this move would broaden current advice about who should get hepatitis B vaccinations.
How is it given?
Like most other vaccines, PreHevbrio is injected into your muscle. It’s usually given in your upper arm.
PreHevbrio is a three-dose vaccine that’s given over a 6-month period. After you get your first shot, you can get your second shot 1 month later. You should get your third shot about 5 months after your second shot.
But, since it’s so new, PreHevbrio isn’t yet incorporated into the CDC’s immunization schedules.
Immunization schedules provide advice about which vaccines you should receive. They also tell you when you should receive them.
PreHevbrio will likely be added to these immunization schedules after a CDC expert panel has the chance to meet and talk about the vaccine. It's expected this will happen in the coming months.
How does PreHevbrio prevent hepatitis B?
PreHevbrio works by showing your body how to make antibodies against HBV. It helps protect you against hepatitis B infection if you’re exposed to HBV.
Specifically, PreHevbrio teaches your body to make antibodies that can recognize three antigens found on the outside of HBV cells. These antibodies help your immune system target and kill HBV cells that have any of the antigens from PreHevbrio.
Of note, PreHevbrio should only be used to help prevent hepatitis B. It’s not meant to treat hepatitis B if you already have it.
How does PreHevbrio compare to other hepatitis B vaccines?
PreHevbrio is the seventh vaccine that’s FDA-approved to help prevent hepatitis B. Other hepatitis B vaccines include:
| Engerix-B | Single-antigen | Children and adults | 3 |
| Recombivax HB | Single-antigen | Children and adults | 3 |
| Heplisav-B | Single-antigen | Adults only | 2 |
| Twinrix | Combination (hepatitis A and B) |
Adults only | 3 |
| Pediarix | Combination (5 different germs) |
Children ages 6 and younger | 3 |
| Vaxelis | Combination (6 different germs) |
Children ages 4 and younger | 3 |
Even though PreHevbrio is the seventh hepatitis B vaccine available in the U.S., its approval is noteworthy. It’s the only three-antigen hepatitis B vaccine approved for adults.
Recombivax HB, Engerix-B, and Heplisav-B can also be used by adults, but they’re single-antigen vaccines. For instance, Engerix-B targets small antigens found on the outside of HBV cells. PreHevbrio targets small, medium, and large antigens on these cells.
Twinrix is similar to Engerix-B, but it also provides protection against hepatitis A. But not every adult needs to be vaccinated against hepatitis A.
And like PreHevbrio, Recombivax HV, Engerix-B, and Twinrix are all three-dose vaccines. Heplisav-B is a two-dose vaccine.
How effective is PreHevbrio at preventing hepatitis B?
Most of what we know about PreHevbrio’s effectiveness comes from two clinical trials. These trials were called “PROTECT” and “CONSTANT.” Both studies looked to see how safe and effective PreHevbrio is. The CONSTANT study also studied manufacturing quality.
In clinical trials, a larger percentage of people who received PreHevbrio made enough antibodies to be considered protected against hepatitis B compared to those who received Engerix-B. This difference was most notable in adults 45 years and older.
Additionally, everyone who received PreHevbrio developed more antibodies against hepatitis B compared to those who received Engerix-B. And the percentage of people with protective antibody levels went down less in the PreHevbrio group after about 12 months.
No safety or manufacturing concerns were found in either study. But, like with all vaccines, many people had a few side effects.
Are there any known side effects of PreHevbrio?
As with all medications and vaccines, you may experience some side effects after getting PreHevbrio. The PROTECT and CONSTANT studies provide information about this vaccine’s side effects.
PreHevbrio’s most common side effects are similar to other vaccines, such as the flu shot. These include:
Pain and soreness where you received your vaccine
Headache
Tiredness
Muscle pain
And compared to vaccines like Engerix-B, PreHevbrio is more likely to cause these types of temporary side effects.
Who should and shouldn’t receive PreHevbrio?
As mentioned, the CDC hasn’t officially included PreHevbrio into its list of recommended vaccines.
But PreHevbrio’s labeling helps offer some preliminary insight into who should and shouldn’t receive the vaccine. If you’re 18 years or older, you may be eligible to get this vaccine.
But if any of the following items apply to you, PreHevbrio may not be the best choice for you:
Age 17 or younger
Have an active hepatitis B infection
Have an allergy to any ingredient in PreHevbrio
Have experienced a severe allergic reaction to another hepatitis B vaccine
It’s not known how this vaccine affects women who are pregnant or nursing. This is also true for people who are receiving dialysis. For more information, talk to your healthcare provider.
When will PreHevbrio be available?
Even though PreHevbrio is now FDA-approved, it’s not quite ready to go. A CDC expert panel still needs to decide how it fits into its vaccine recommendations
According to VBI Vaccines, PreHevbrio’s manufacturer, the vaccine should be available in the U.S. no later than March 2022. Check back with GoodRx for updates as more information becomes available about this new vaccine.
The bottom line
PreHevbrio is a new hepatitis B vaccine that’s available for adults 18 and older. It’s a three antigen vaccine, so it’s thought to provide better protection than single-antigen vaccines like Engerix-B. But it’s not available quite yet — it’s expected to be available in the U.S. in early 2022. If you have questions about this vaccine, talk to your healthcare provider.
Why trust our experts?
References
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Hepatitis B Foundation. (2020). Vaccine schedules.
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VBI Vaccines. (2021). VBI Vaccines announces publication of results from pivotal phase 3 study, PROTECT, of VBI’s prophylactic 3-antigen hepatitis B vaccine candidate in The Lancet Infectious Diseases.
Vesikari, T., et al. (2021). Immunogenicity and safety of a tri-antigenic versus a mono-antigenic hepatitis B vaccine in adults (PROTECT): a randomised, double-blind, phase 3 trial. The Lancet Infectious Diseases.
Vesikari, T., et al. (2021). Immunogenicity and safety of a 3-antigen hepatitis B vaccine vs a single-antigen hepatitis B vaccine: a phase 3 randomized clinical trial. JAMA Network Open.
