Merck (NYSE: MRK), known as MSD outside the U.S. and Canada, announced that the National Medical Products Administration (NMPA) of China has approved GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for use in males aged 9–26. This marks the first HPV vaccine approved for males in China.
GARDASIL is now authorized in China to help prevent anal cancers caused by HPV Types 16 and 18, genital warts (condyloma acuminata) caused by HPV Types 6 and 11, and precancerous or dysplastic lesions—grade 1, grade 2, and grade 3 anal intraepithelial neoplasia (AIN)—caused by HPV Types 6, 11, 16, and 18.
“This approval represents a significant milestone in public health,” said Joseph Romanelli, president of Human Health International at Merck. “Since its initial approval, our HPV vaccines have protected over 50 million females in China from certain HPV-related cancers and diseases. We are excited to extend this protection to Chinese males, helping to prevent HPV-related cancers and conditions in this new population.”
Expanded Indications for GARDASIL
GARDASIL is indicated for use in females aged 9–45 to prevent cervical, vulvar, vaginal, and anal cancers caused by HPV Types 16 and 18, as well as precancerous lesions and genital warts caused by HPV Types 6, 11, 16, and 18.
For males aged 9–26, GARDASIL is indicated to prevent anal cancer, precancerous lesions, and genital warts caused by the same HPV types.
Key Considerations
- GARDASIL does not eliminate the need for regular cancer screenings as recommended by healthcare providers.
- It does not protect against HPV types not covered by the vaccine or infections acquired before vaccination.
- GARDASIL is not a treatment for existing HPV-related diseases or conditions.
- Vaccination may not provide protection for all individuals.
Safety Information
- GARDASIL is contraindicated for individuals with severe allergies to yeast or previous doses of the vaccine.
- A 15-minute observation period post-vaccination is recommended to monitor for syncope, which may occur and sometimes includes transient seizure-like movements.
- The vaccine’s safety and effectiveness in pregnant women have not been established.
- Common side effects include headache, fever, nausea, dizziness, and injection-site reactions like pain, swelling, and bruising.
Dosage and Administration
GARDASIL is administered intramuscularly in the deltoid or anterolateral thigh. The vaccination regimen for individuals aged 9–26 consists of three doses over six months: at 0, 2, and 6 months.
As per the press release, this approval marks a crucial step in expanding HPV prevention efforts in China, providing broader protection against HPV-related diseases for males and advancing public health initiatives.