Herpes Vaccine Availability Is Aspirational in 2025

With about 20% of young adults infected with one of the herpes simplex viruses (HSV) in 2024, the World Health Organization (WHO) recently raised awareness of the related costs and vaccine candidate landscape.

On December 11, 2024, the WHO revealed that the Global Health Sector Strategy on HIV, viral hepatitis, and sexually transmitted infections for 2022-2030 highlighted the cost of genital herpes infections. The WHO reaffirmed that it is also working to advance research and develop new prevention tools, such as vaccines.

Dr. Meg Doherty, Director of Global HIV, Hepatitis, and Sexually Transmitted Infections Programs for the WHO, commented on December 11, 2024, "Better herpes prevention and treatment options are urgently needed to reduce transmission....."

WHO estimates that over 200 million people aged 15 to 49 suffered at least one such symptomatic episode in 2020. In addition to sores, genital herpes can, on occasion, lead to serious complications, including neonatal herpes.

Economic losses due to genital herpes infection can be significant when considering the lifelong nature of the disease. Furthermore, quality-of-life losses have been found to outweigh treatment spending and productivity reductions. 

A study published in July 2024 showed that both genital HSV-2 ($31.2 billion) and HSV-1 ($4 billion) infection-related healthcare expenditures and productivity loss were estimated in 2016. 

According to the U.S. CDC, HSV-1 often causes oral herpes, resulting in cold sores or fever blisters on or around the mouth. Most people with oral herpes get it during childhood or young adulthood from non-sexual contact with saliva.

Unfortunately, genital herpes has become common in the U.S. CDC estimates show there are over 500,000 new genital herpes infections annually.

Most of the time, herpes infections cause no or few symptoms. However, for some people, they lead to painful genital sores and blisters that can recur throughout life, causing significant discomfort and often requiring multiple healthcare visits.

Currently, there is no cure for herpes, although some OTC treatments can relieve symptoms.

Developing preventive and therapeutic HSV vaccines has been challenging for decades.

In 2024, the WHO published its preferred product characteristics for Alpha (α) herpesvirus vaccines and updated its pipeline review.

As of December 25, 2024, herpes vaccine candidates are based on DNA, Messenger RNA (mRNA), protein subunits, killed virus, and attenuated live virus vaccine technologies.

For example, Moderna Inc.' sInc.' vaccine candidate mRNA-1608 is an mRNA vaccine targeting HSV-2. A Phase 1/2, Randomized, Observer-Blind, Controlled, Dose-Ranging Study of mRNA-1608 indicates an estimated completion date of April 11, 2025.

Dr. Sami Gottlieb, Medical Officer within WHO's Sexual and Reproductive Health and Research, commented in a media release that "expanding research and investment in developing new herpes vaccines and therapies and their equitable use could play a critical role in improving the quality of life for people around the world."

As of" December 2024, the U.S. Food and Drug Administration, Brazil, Canada, China, Europe, India, Japan, and the U.K. had not authorized preventive or therapeutic herpes HSV-1 or HSV-2 vaccines. The WHO, the U.S. National Instuties of Health, and global partners launched STI Watch, a portal containing updated information on vaccine development status.