MSD Pharma gets CDSCO Panel nod to update prescribing information of Human Papillomavirus 9-valent Recombinant Vaccine
New Delhi: MSD Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to update the prescribing information (PI) of the Human Papillomavirus 9-valent Recombinant Vaccine (Serotypes 6, 11, 16, 18, 31, 33, 45, 52, and 58) in line with EU SmPC.
This came after MSD Pharmaceutical presented its proposal for an update of prescribing information (PI) of the Human Papillomavirus 9-valent Recombinant Vaccine (Serotypes 6, 11, 16, 18, 31, 33, 45, 52, and 58).
The 9-valent HPV vaccine, which protects against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, is safe and effective and will further reduce the incidence of HPV infection, as well as HPV-related cancers. It can also indirectly protect unvaccinated individuals through herd immunity. With an effective vaccination program, most cervical cancers can be prevented. Analyses show that the cost-effectiveness of the 9-valent HPV vaccine in female patients is comparable to the original quadrivalent HPV vaccine (which protects against HPV types 6, 11, 16, and 18) currently in use.
Human papillomavirus (HPV) is a DNA virus with strains capable of causing anogenital warts, as well as cancers of the cervix, vagina, vulva, anus, penis, oral cavity, and oropharynx (level II).
Human Papillomavirus 9-valent Recombinant Vaccine helps protect individuals ages 9 to 45 against the following diseases caused by 9 types of HPV: cervical, vaginal, and vulvar cancers in females, anal cancer, certain head and neck cancers, such as throat and back of mouth cancers and genital warts in both males and females.
At the recent SEC meeting for vaccine, the expert panel reviewed the proposal to update prescribing information (PI) of the Human Papillomavirus 9-valent Recombinant Vaccine (Serotypes 6, 11, 16, 18, 31, 33, 45, 52, and 58).
After detailed deliberation, the committee recommended an update of prescribing information (PI) in line with EU SmPC.
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