Human Papillomavirus Quadrivalent (Type 6,11,16,18) Vaccine, Recombinant

727 words - 3 pages

Biological Product
HPV is the most sexually transmitted infection. With more than 40 HPV types that can infect the genital areas of male and female, vaccines for prevention are essential. Human papillomavirus quadrivalent (Type 6,11,16,18) Vaccine known by the trade name “Gardasil” is used for protection against such viruses. Gardasil is a FDA approved human papillomavirus (HPV) vaccine manufactured by Merck & Co., Inc.

Reason for interest
Cervical cancer is the second most common cancer associated with HPV affecting women, with about 470,000 new cases and 233,000 deaths each year. With such high incidence rates, I think it is very important to create awareness about the availability of ...view middle of the document...

The virus like particles does not contain viral DNA and thus cannot infect cells or reproduce or cause disease. The HPV infects only humans but animal studies with analogues of animal papillomavirus suggest that efficacy of L1VLP vaccine is mediated by development of human immune response.

Indications For Use
Gardasil is a vaccination for both females and males providing protection against several cancers and diseases. It is used in females between ages 9-26 years of age for preventing vulvar, vaginal, cervical and anal cancers. Genital warts and precancerous lesions called intraepithelial neoplasia associated with the genital organs can also be prevented. In males of age 9-26 years used to prevent genital warts and anal cancer.

Regulation by CBER
CBER is responsible for the regulation of biological products including vaccines, blood products etc. Vaccine development is especially complex and challenging issues arise during development process, hence CBER closely monitor’s the product throughout from development to post-marketing. Regulating vaccines under development to treat or prevent non-infectious diseases like cancers is the CBER responsibility. Thus CBER regulated Gardasil being a vaccine under development for Cancers.

Guidance Documents
Several guidance documents are available for successful development and approval of...

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