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Discussion of Complete Response Letter Safety Items - Cervarix, January 16, 2008 Cervarix - fda

Discussion of Complete Response Letter Safety Items - Cervarix, January 16, 2008 Cervarix - fda-2025

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The document is a record of a telephone conversation between GlaxoSmithKline (GSK) and the FDA regarding safety concerns related to the Human Papillomavirus Vaccine, Cervarix. It discusses GSK's responses to items raised in a Complete Response letter from the FDA, particularly focusing on safety data, adverse events, and proposals for additional analyses and updates on various safety outcomes. Key topics include the evaluation of neuroinflammatory events, pregnancy outcomes, serious adverse events, and the need for unblinded data to facilitate FDA review. The conversation outlines GSK's commitment to providing comprehensive safety information and addressing FDA's concerns before the vaccine's potential licensure.

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When was Cervarix FDA approved?

On October 16, 2009, the Food and Drug Administration (FDA) licensed bivalent human papillomavirus vaccine (HPV2; Cervarix, GlaxoSmithKline) for use in females aged 10 through 25 years. Cervarix is the second human papillomavirus (HPV) vaccine licensed for use in females in the United States.

Which is better, Gardasil or Cervarix?

Cervarix has higher capability of preventing HPV 45 and HPV 52 infection than Gardasil, and similar potential against HPV 31. These viruses also cause cervical cancer.

Is CERVARIX a vaccine for the prevention of HPV 16 18 associated cervical cancer?

Cervarix is composed of HPV16 and HPV18 L1 virus-like particles (VLPs) formulated in ASO4 adjuvant. Vaccination with Cervarix has been shown to protect women against a high proportion of precursor lesions of cervical cancer caused by these two HPV types.

Which is better, Gardasil or CERVARIX?

Cervarix has high anti-HPV16 and HPV18 antibody titers for at least 9.4 years [15] in longitudinal follow-up studies; Gardasil has plateaued anti-HPV16 titers well above natural infection titers for at least 9 years, but anti-HPV18 titers that are not different from natural infection titers as early as 24 months after