Next Step for the Vaccine: Fast-tracking through the FDA

By Vera Viner

If you could prevent a horrible, debilitating disease and keep millions of women healthy, would you do so? Would you do everything in your power to make it happen? While many of us may think we would, we tend to focus more on our day-to-day life filled with work, family, and similar responsibilities. Thankfully, we have a handful of saints in this world who are working every minute to make miracles happen.

Dr. Kathleen Ruddy, Founder of the Breast Health and Healing Foundation, and Dr. Vincent Tuohy of the Cleveland Clinic have been discussing the imperative steps necessary to fast-track the FDA clearance of Phase I trials for the preventive breast cancer vaccine. These two souls have gone out of their way to try to help the thousands of women around the country and millions more around the globe who are diagnosed with breast cancer every single year.

Three years ago, Tuohy and his team of researchers published their results of the preventive vaccine in the journal Nature Medicine. The vaccine was 100 percent effective in preventing breast cancer in mice bred to develop the disease. All of the mice in the placebo group, however, developed breast cancer.

The protein alpha-lactalbumin was used as the primary target for Tuohy’s vaccine. It was determined that the vaccine could both prevent breast cancer in mice and stop the growth of already-existing tumors.

“We believe that this vaccine will someday be used to prevent breast cancer in adult women in the same way that vaccines prevent polio and measles in children,” said Dr. Vincent Tuohy.

Now that we have gathered enough funding to continue with Phase I clinical trials and determine whether the vaccine is safe to use in women, we await FDA approval to begin these trials. Dr. Ruddy and Dr. Tuohy are discussing the necessary steps for fast-tracking this process and possibly saving countless lives in the process, given that the vaccine is found safe and effective.