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Vaccine Safety Resources - 2009 H1N1 Flu

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Why the 2009 H1N1 Influenza Vaccine is Safe
  • The Michigan Department of Community Health (MDCH), the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are closely monitoring the safety of the licensed 2009 H1N1 flu vaccine.
  • The 2009 H1N1 flu vaccine is being manufactured with the same, well-established and licensed processes used to make seasonal flu vaccine.
  • Vaccines are held to the highest standard of safety and are continually monitored.
  • The U.S. currently has the safest, most effective vaccine supply in history.

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Common Side Effects of the 2009 H1N1 Influenza Vaccine
  • Over the years, hundreds of millions of Americans have received flu vaccines. The most common side effects are mild: Soreness, redness, tenderness or swelling where the shot was given.
  • Immunizations, like any medication, can cause adverse side effects.
  • Serious adverse reactions are uncommon.

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Why it is Important to Receive the 2009 H1N1 Influenza Vaccine
  • Vaccination is the single best way to prevent the flu. 
  • A decision not to immunize is risky, potentially putting the child, and others who come into contact with him or her, at risk of getting the disease that could be dangerous or deadly.
  • In some instances, the 2009 H1N1 flu virus can cause serious health issues for healthy individuals.

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Initial Target Groups for the 2009 H1N1 Influenza Vaccine

The CDC's Advisory Committee on Immunization Practices (ACIP), a group of 15 experts in immunization-related fields, makes recommendations on who should receive vaccines based on: Seriousness of the disease, the age and risk groups most affected, the ability to make vaccines, vaccine supply issues, and more. At the July 29, 2009 public meeting, ACIP recommended that these groups initially receive the H1N1 vaccine:

  • Pregnant women: They are at higher risk of complications and can potentially provide protection to infants who cannot be vaccinated;
  • Household contacts and caregivers for children younger than 6 months of age: Younger infants are at higher risk of complications and cannot be vaccinated. Vaccination of those in close contact with infants younger than 6 months old might help protect infants by "cocooning" them from the virus;
  • Healthcare and emergency medical services personnel: Infections among healthcare workers have been reported and this can be a potential source of infection for vulnerable patients. Also, increased absenteeism in this population could reduce healthcare system capacity;
  • All individuals from 6 months through 24 years of age: Cases of the 2009 H1N1 virus have been reported in children and healthy young adults who are in close contact with each other in school and daycare settings, which increases the likelihood of disease spread;
  • Adults 25 through 64 years of age who have underlying health conditions: They are at a greater risk of medical complications from the flu.

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After the Initial Target Groups Are Vaccinated
  • There is a possibility that the vaccine will initially be available in limited quantities, which is why the first target groups were listed above.
  • Once the vaccine has reached the target groups, healthy persons ages 25 through 64 years should be vaccinated followed by all persons 65 years of age and older who have not yet received the vaccine should get vaccinated because vaccination is the most effective method for preventing flu and flu-related complications.

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Vaccine Safety Monitoring
  • MDCH, CDC and FDA are monitoring the safety of the 2009 H1N1 flu vaccine.
  • Monitoring vaccine safety helps identify, in a timely fashion, any adverse side effects following vaccination.
  • Side effects may be by chance or caused by vaccination.
  • Two primary systems used to monitor the safety of the 2009 H1N1 flu vaccine are:  
    • Vaccine Adverse Event Reporting System (VAERS), which is jointly operated with FDA and CDC; and
    • Vaccine Safety Datalink (VSD) Project
  • MMWR - Safety of Influenza A (H1N1) 2009 Monovalent Vaccines --- United States, October 1--November 24, 2009

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Resources

Centers for Disease Control and Prevention (CDC)

U.S. Food and Drug Administration (FDA)

National Institutes of Health (NIH): National Institute of Allergy and Infectious Diseases (NIAID)

Michigan Department of Community Health

Additional Resources

VAERS Resources

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