Debate continues over the policy as the national human papillomavirus (HPV) vaccination program, previously limited to females, expands to include boys. Some question whether it is necessary to include males under limited finances, while others argue it is an inevitable step given the infection's characteristics and the vaccine's preventive effects.
According to the Korea Disease Control and Prevention Agency on the 18th, the national HPV vaccination support program, which had covered females ages 12–26, will expand to include 12-year-old boys (born in 2014) starting on May 6.
To that end, the related budget rose by about 9.3 billion won, from 21 billion won last year to 30.3 billion won this year. The total budget for national immunization, including influenza and HPV, also increased from 356.7 billion won to 437.1 billion won.
◇"To eliminate HPV, 80% of both men and women must be vaccinated… herd immunity is key"
The focus of the debate is on "priorities." Some argue that more urgent vaccines should be supported first with limited resources, but experts say it is unavoidable to expand vaccination to males given HPV's characteristics.
HPV is a very common virus to contract. According to the U.S. Centers for Disease Control and Prevention (CDC), almost everyone is infected with HPV at least once in their lifetime, and 90% of cervical cancers in women and about 70% of penile, oropharyngeal, oral and anal cancers in men are related to HPV.
For many infected people, the virus clears naturally within two years, but in about 10%, the infection persists and can lead to cancer. The International Papillomavirus Society (IPVS) reports that 5.2% of cancers worldwide are caused by HPV, with 600,000–800,000 cases annually.
In particular, males are more vulnerable in terms of immune response. According to IPVS data, the antibody formation rate after HPV infection is about 70%–80% in females, while it is only 20%–30% in males. As of 2020, among roughly 6,400 head and neck cancer cases in Korea, 4,800 occurred in males.
There is also a clear gap in vaccination between females and males. As of last year, the HPV first-dose coverage rate among female adolescents ages 12–17 reached 87.6%, while male adolescents fell short of 1%.
Experts stress that HPV prevention should be approached from a "herd immunity" perspective, not an individual one. In fact, 36 of the 38 OECD countries recommend HPV vaccination for both males and females, and analyses suggest that about 80% coverage in each group is needed to eliminate HPV.
Another factor fueling debate is that, unlike other vaccines, it is difficult to verify HPV vaccine effectiveness immediately. However, since the link between HPV-related cancers and the causative virus has been clearly established, experts generally agree there is ample medical evidence of preventive effect.
Lee Se-young, an otolaryngology professor at Chung-Ang University Hospital and executive director of the Korean Society of Head and Neck Surgery, said, "You can confirm the effects of COVID-19 or flu vaccines in a short period after vaccination, but for HPV, infection occurs in young adulthood and it takes 10–30 years for cancer to develop, making it hard to confirm immediate preventive effects," adding, "That is why debate over the preventive effect keeps recurring."
◇OECD 29 countries use the "9-valent," but Korea uses the "4-valent"
There is also heated debate over which vaccines to include in the national immunization program.
The only HPV vaccines distributed worldwide are "Cervarix (bivalent)" by GSK plc, and "Gardasil (quadrivalent)" and "Gardasil 9 (9-valent)" by Merck. Among these, the government provides the bivalent Cervarix and the quadrivalent Gardasil free of charge.
HPV vaccines are categorized as bivalent, quadrivalent, or 9-valent depending on the types of virus they can prevent. The bivalent covers types 16 and 18, which cause about 70% of cervical cancers; the quadrivalent adds types 6 and 11, which cause more than 90% of genital warts. The 9-valent adds five high-risk types (31, 33, 45, 52, 58) to the quadrivalent, currently providing the broadest protection.
Internationally, the 9-valent vaccine is becoming the standard. Of the 38 OECD countries, 29, including the United States, the United Kingdom, Canada and Australia, already provide the 9-valent vaccine to both males and females, and in the United States, use of the bivalent and quadrivalent vaccines has effectively ended.
By contrast, some countries, including Korea, the Netherlands, Costa Rica and Colombia, still fund the bivalent or quadrivalent vaccines.
As a result, there are voices of regret that Gardasil 9, the 9-valent vaccine with the widest preventive range, was left out of the national immunization program.
Demand for the 9-valent vaccine is overwhelming at vaccination sites. According to IQVIA, Gardasil 9's sales reached 117 billion won in 2023, ranking third among domestic pharmaceutical sales. Gardasil 4's sales were in the 30 billion won range.
Min Kyung-jin, an obstetrics and gynecology professor at Korea University Ansan Hospital, said, "HPV types 52 and 58, which are common in Asia, can be prevented only with the 9-valent," adding, "About 90% of cervical cancers worldwide are caused by nine HPV types, so Korea also needs to include the 9-valent vaccine in the national program for both males and females to maximize preventive effect."
◇"Switching from 4-valent to 9-valent requires an additional 16.5 billion won"… 'Pacing' due to fiscal limits
The government's decision to keep the quadrivalent vaccine was driven by expense concerns.
In a written answer to a National Assembly audit question from lawmaker Kim Nam-hee of the Democratic Party of Korea last year, the Korea Disease Control and Prevention Agency said, "If the national immunization program is fully switched to the 9-valent, an additional budget of about 9 billion–16.5 billion won would be needed depending on coverage," adding, "We agree on the need, but an immediate switch is difficult due to budget issues."
The actual expense gap is also significant. According to the Health Insurance Review & Assessment Service (HIRA), the nationwide average inoculation expense for Gardasil 9 is 219,032 won, ranging from 160,000–300,000 won by provider. Completing all three doses costs individuals about 180,000–600,000 won.
By contrast, the quadrivalent vaccine costs about 60,000–70,000 won per dose, while the 9-valent is around 110,000–130,000 won per dose, a sizable unit-price gap. Considering the national program covers about 250,000 people annually, the unit-price increase alone would require more than 10 billion won in additional funds per year.
Another burden is that manufacturer Merck has steadily raised its supply price. Gardasil 9 saw price hikes of 15% in April 2021 and 8.9% in June 2022, two years in a row.
Lee Hye-rim, head of the Korea Disease Control and Prevention Agency's National Immunization Program Division, said, "We are continuing consultations with fiscal authorities to switch to the 9-valent vaccine," but added, "Within limited resources, we decided it was a priority to expand eligibility to male adolescents."