CMV Vaccines and Clinical Trials
Currently, there is no CMV vaccine available to prevent congenital CMV. CMV vaccines are still in the research and development stage. Many experts believe that a CMV vaccine is possible within the next 10 to 20 years, but a CMV vaccine is unlikely to occur without the awareness and support of the general public, the pharmaceutical industry, and the federal government.
There are many pharmaceutical industry-sponsored clinical trials for CMV vaccines, but these focus on other at-risk populations, including HIV patients and organ transplant patients. Information and findings from these other at-risk population CMV vaccine trials cannot be applied towards a congenital CMV vaccine.
CMV Vaccine Trials
Vaccine clinical trials include the following:
- Phase I trials - costs less than $1 million
- Phase II trial - costs $5-$10 million
- Phase III trial - costs $10-$100 million
For a congenital CMV vaccine, there have been approximately 10 phase I trials, 2 phase II trials, and no phase III trials to date.
In 1999, the National Institute of Medicine (IOM) reviewed 26 conditions with the potential for vaccine prevention and ranked different candidate vaccines from Levels I-IV (highest to lowest) based on cost impact and Quality of Life Adjusted Year (QALY) saved. A congenital CMV vaccine, given to 12-year-olds, was ranked the first priority in the Level I group as a first priority because of cost savings as well as the human suffering that would be alleviated by stopping CMV.
In the early 1990s, the annual cost for caring for children born with congenital CMV was estimated at $1-$2 billion for the U.S. alone. Because children born with congenital CMV often require long-term care and extensive medical and surgical interventions, the average cost per child was estimated at $300,000.
There have been no recent studies to re-evaluate the cost impact of congenital CMV.
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