Directing H1N1 Vaccine Safety Monitoring
November 2, 2009
Careful stewardship of vaccine safety is integral to maintaining public health and trust in the H1N1 immunization program. It's a responsibility we take very seriously. Public health officials are working together to ensure that H1N1 vaccines are very safe and possible adverse events are investigated quickly and transparently.
Each year, millions of Americans safely use seasonal flu vaccines. H1N1 vaccines are made the same way as seasonal flu vaccines and have been tested by the National Institutes of Health and licensed for use by the Food and Drug Administration. In fact, if the H1N1 virus had emerged earlier in the year, it would have been part of this year's seasonal flu.
There are many systems in place to monitor the H1N1 vaccine for serious side effects. Today, the Department of Health and Human Services released a report on how the federal government in partnership with state and local health officials, physicians, universities and health plans are monitoring the H1N1 vaccine for safety. The report explains how federal vaccine safety monitoring is being improved to quickly track potential health problems following immunization. A copy of the report is available here.
The goal of these efforts is to speed up the availability of safety data to inform the immunization program, health care providers, and the public. Improved systems also will help scientists determine if health problems following immunization happen by chance, or could be related to a vaccine. A new paper published in the scientific journal the Lancet includes more information on health problems that could occur during the H1N1 immunization program but which may not necessarily be related to the vaccine. Click here to read a summary of the Lancet article.
Some of the existing safety systems, which have been in place for many years, and new systems for the 2009 H1N1 flu include:
- Large, linked databases from health insurance plans are being matched with state immunization registries to conduct near-real time surveillance of the health outcomes of more than 20 million people receiving vaccination
- Reporting capacity and staffing has been increased more than 10-fold to collect reports from providers and the public of potential health problems
- An independent group of experts has been established to conduct regular, rapid reviews of data from federal safety monitoring systems as it becomes available
It's important to learn about H1N1 flu to determine if you or your loved ones might be at risk for serious disease or complications. Vaccination is the best defense against illness and will help reduce the spread of disease. Talk with your health care provider so you can make the best decision for you and your family. For more information about vaccine safety click here.
