MSD Pharma gets CDSCO Panel nod to update prescribing information of Human Papillomavirus 9-valent Recombinant Vaccine

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-09-08T18:00:01+05:30 | Updated On 8 Sept 2024 6:00 PM IST

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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Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751