US major Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its recombinant human papillomavirus (HPV) quadrivalent vaccine, Gardasil, for use in males aged 9 to 26. This approval expands the vaccine’s application to include prevention of anal cancer caused by HPV16 and 18, genital warts (condyloma acuminatum) caused by HPV6 and 11, and precancerous or atypical lesions caused by HPV6, 11, 16, and 18.
Vaccine Efficacy and Indications
The HPV quadrivalent vaccine provides protection against infection with low-risk HPV types 6 and 11, which are responsible for most genital warts, and against high-risk HPV types 16 and 18, which cause several types of precancers and cancer. Since its initial approval in China in 2017, Gardasil has been approved for the prevention of cervical cancer, cervical intraepithelial neoplasia (CIN2/3), and cervical adenocarcinoma in situ (AIS) caused by high-risk HPV16 and 18 in women aged 9 to 45.
Significance of the Approval
The expanded approval for males underscores the broad protective potential of Gardasil in preventing HPV-related diseases. This development highlights MSD’s ongoing commitment to public health and its efforts to provide comprehensive protection against HPV infections, benefiting a wider demographic.-Fineline Info & Tech
