Approval of Merck’s GARDASIL® Expanded for Males in China
Merck (NYSE: MRK), known as MSD outside the United States and Canada, has announced that the National Medical Products Administration (NMPA) of China has approved GARDASIL® (Human Papillomavirus Quadrivalent Vaccine, Recombinant) for use in males aged 9 to 26. This approval marks a significant milestone, as GARDASIL becomes the first HPV vaccine approved for males in China. The vaccine is now authorized to prevent certain HPV-related cancers and diseases, including anal cancers caused by HPV Types 16 and 18, genital warts (condyloma acuminata) caused by HPV Types 6 and 11, and precancerous lesions in the anal region caused by HPV Types 6, 11, 16, and 18.
Joseph Romanelli, President of Human Health International at Merck, stated, “The approval of GARDASIL for use in males in China is a major step forward in improving public health. Since the initial approval, our HPV vaccines have helped protect over 50 million women in China from HPV-related cancers and diseases. With this expanded approval, we are now positioned to help protect Chinese males from the same threats.”
About GARDASIL’s Indications
GARDASIL is a vaccine intended for both females and males. In females aged 9 through 45, it helps prevent cervical, vulvar, vaginal, and anal cancers caused by HPV Types 16 and 18. It also prevents precancerous lesions (dysplasia) caused by HPV Types 6, 11, 16, and 18, and genital warts caused by HPV Types 6 and 11.
For males aged 9 through 26, GARDASIL is approved to prevent anal cancer caused by HPV Types 16 and 18, as well as precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, and 18. It also helps prevent genital warts caused by HPV Types 6 and 11.
It is important to note that while GARDASIL offers protection against certain types of HPV, it does not eliminate the need for regular screening for cervical, vulvar, vaginal, or anal cancers, as recommended by healthcare providers. Additionally, the vaccine does not provide protection against diseases caused by HPV types not covered by the vaccine or against types to which a person has already been exposed through sexual activity.
Safety Information and Side Effects
GARDASIL has been proven to be safe for most individuals, but like any vaccine, it is not without its risks. The vaccine is contraindicated for individuals with hypersensitivity or severe allergic reactions to yeast or any previous doses of GARDASIL. Additionally, individuals receiving the vaccine may experience syncope (fainting), sometimes associated with injury. As a precaution, individuals should be observed for 15 minutes after vaccination.
Other common side effects of GARDASIL include headache, fever, nausea, dizziness, and injection-site reactions such as pain, swelling, erythema (redness), pruritus (itching), and bruising. The duration of immunity provided by GARDASIL has not been definitively established, and the vaccine has not been studied in pregnant women.
Vaccination Schedule
GARDASIL is administered via intramuscular injection, typically in the deltoid (upper arm) or the anterolateral (front side) area of the thigh. For individuals aged 9 through 26, the complete vaccination schedule consists of three doses, administered at 0, 2, and 6 months.
Merck’s Commitment to Public Health
Merck, known as MSD outside of the United States and Canada, has been at the forefront of innovation in the pharmaceutical industry for more than 130 years. The company is dedicated to using the power of science to save and improve lives around the world. With a diverse and inclusive global workforce, Merck continues to lead in research and development, working to provide innovative solutions for the prevention and treatment of diseases.
As part of its mission, Merck focuses on delivering high-impact medicines and vaccines that meet critical health needs. Through its continued commitment to public health, Merck aims to improve access to life-saving treatments and to advance global healthcare solutions.
Conclusion
The expanded approval of GARDASIL for males in China represents an important step in the fight against HPV-related cancers and diseases. With this new indication, GARDASIL is poised to help protect millions of Chinese males from the harmful effects of HPV, contributing Approval to Merck’s ongoing efforts to reduce the burden of HPV-related conditions worldwide.
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