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How vaccines are tested for safety

Miami Herald - November 16, 2009
Fred Tasker


The FDA OK'd swine flu vaccines on Sept. 15 after receiving preliminary results from five clinical trials on more than 3,000 volunteers at sites including Baylor University College of Medicine, Cincinnati Children's Hospital, the Hope Clinic of Emory University, St. Louis University and others.

Testing is run by the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health.

In the trials, the vaccine was well tolerated, and was effective in children 10 to 17 and adults 18 and older when given in a single dose. Children 6 months to 9 years old need two doses for effective immunity. Results of these studies are at www3.niaid.nih.gov/news/newsreleases.

In another NIH study of 50 pregnant women reported on Nov. 2, more than 92 percent achieved excellent immunity from swine flu, with no adverse effects. Information is at cdc.gov/H1N1flu/vaccination/pregnant_qa.htm.

The NIAID has 20 longer-term clinical trials underway to further test the vaccine in adults, children, pregnant women, the elderly, people with asthma and people with HIV. Information is at clinicaltrials.gov/ct2/home.

MONITORING

The CDC monitors adverse vaccine reactions through two programs:

Vaccine Adverse Event Report System: Any individual, doctor, nurse, clinic or hospital can report an adverse reaction at http://vaers.hhs.gov/index.

Vaccine Safety Datalink Project: The CDC and eight large medical organizations will watch for adverse reactions in 9 million people who get the vaccines.

MORE INFORMATION

Here are websites for more swine flu safety information:

CDC information on H1N1 vaccine safety, side effects, testing procedures and outcomes: cdc.gov/h1n1flu/vaccination/vaccine_safety_qa.htm

CDC update on spread of swine flu: cdc.gov/h1n1flu/

CDC general information on swine flu: flu.gov/

The Miami-Dade Health Department website: dadehealth.org

Broward County Health Department website: browardchd.org

ftasker@MiamiHerald.com


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