Gardasil, a Merck & Co. experimental vaccine the protects women from for types of HPV infection – the major cause of cervical cancer – is considered as safe and effective by FDA staff. An FDA advisory panel meets tomorrow to discuss the safety and effectiveness of Gardasil.
HPV (human papilloma virus) infection causes warts and is responsible for the majority of cases of cervical cancer in the world. Gardasil is seen as a way of protecting women from cervical cancer and genital warts.
Gardasil has not yet been approved by the FDA. If it is approved it will probably have sales of over $2 billion per year.
The FDA staff found that the side effects of Gardasil did not demonstrate a safety signal of concern.
HPV is transmitted sexually. There are two types, called 16 and 18, which cause 70% of cervical cancer cases worldwide. Cervical cancer kills 300,000 to 500,000 women each year. Gardasil protects women from four types of HPV, including 16 and 18, the other two are responsible for most genital warts.
The FDA panel that meets tomorrow will advise the FDA whether or not to approve the drug. The FDA usually goes along with the recommendations of the panel.
There is concern for the safety of patients who are already infected and are given the vaccine, as it can lead to a raised number of cases of a cancer precursor.
Written by: Christian Nordqvist
Editor: Medical News Today