FDA to Decide on Approval of Prostate Cancer Vaccine
Vaccine and various other pharmaceutical manufacturers must conduct several tests and invest a substantial amount of money and time before the U.S. Food and Drug Administration (FDA) approves their product for patient and consumer use. A prostate-cancer vaccine, Provenge, has been 20 years in the making. If approved by the FDA, Provenge would represent a milestone in therapeutic cancer vaccine science and development. But are potential dangerous side effects ruled-out?
According to the Nature Publishing Group, the FDA is scheduled to make a decision regarding Provenge’s approval by May 1. Interestingly, some vaccines have received license to be used in other countries; however, no vaccines have been allowed on the U.S. market. Based on the article, a university of Pittsburgh School of Medicine immunologist stated that an FDA-approved vaccine “would legitimize the field” and provide prospective new treatment for male patients with highly developed prostate cancer.
The functionality of Provenge relies on being custom-made for each particular patient by harvesting one of his immune cells and exposing them to a cancer-related protein called prostatic acid phosphatase. When the vaccine is given to the patient, the exposed cells are supposed to initiate an immune assault on tumor cells.
For officials, consumers and vaccine injury lawyers who may be questioning the safety of the vaccine, others hope that Provenge will help lower the amount of prostate cancer deaths, which amounted to over 28,000 men in the United States in 2008, according to the article. One of the main concerns with any new vaccine or drug is making sure that it will not create any potential or new health problems due to an undetected manufacturing or design flaw. Similarly, manufacturers are responsible for conducting a wide scope of clinical trials to ensure that any potential side effects are identified and outweigh the risk of not taking the product.
