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 influenza vaccine.
The 2009 H1N1 influenza vaccine is being manufactured by each of the four seasonal influenza manufacturers with the same, well-established and licensed processes used to make seasonal influenza 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.
As with seasonal influenza vaccine, the 2009 H1N1 vaccine will not contain an adjuvant.
Common Side Effects of the 2009 H1N1 Influenza Vaccine
Over the years, hundreds of millions of Americans have received influenza vaccines. The most common side effects are mild soreness, redness, tenderness or swelling where the shot was given.
Serious adverse reactions are uncommon.
When seasonal influenza vaccine is administered it has proven to be safe; however vaccines, like any medication, carry some risks. As H1N1 vaccine is produced using the same processes as seasonal influenza vaccine, it is anticipated that the safety of licensed 2009 H1N1 vaccine will be similar to seasonal influenza vaccines
Why it is Important to Receive the 2009 H1N1 Influenza Vaccine
Vaccination is the single best way to prevent influenza.
A decision not to immunize is risky, potentially putting the individual, 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 influenza virus can cause serious health issues for healthy individuals.
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 for the prevention and control of vaccine-preventable diseases based on: evolving burden of illness caused by the virus, the age and risk groups most affected, progress in developing vaccines, anticipated vaccine supply, and various possible vaccination strategies. At the July 29, 2009 public meeting, ACIP recommended that these groups initially receive the 2009 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 widely 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.
There is a possibility that the vaccine will initially be available in limited quantities, which is why the first target groups were established (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 olderwho have not yet received the vaccine should get vaccinated because vaccination is the most effective method for preventing influenza and influenza-related complications.
To date, fewest 2009 H1N1 influenza cases occur in older adults, but the highest case-fatality ratio is in this age group.
In some instances, the 2009 H1N1 influenza virus can cause serious health outcomes for healthy individuals; vaccines are highly effective in preventing influenza disease.
MDCH, CDC and FDA are monitoring the safety of the 2009 H1N1 influenza vaccine.
Monitoring vaccine safety helps identify, in a timely fashion, any clinically significant adverse reactions following vaccination that may be of public health concern.
Side effects may be coincidental to or caused by vaccination.
Two primary systems used to monitor the safety of the 2009 H1N1 influenza vaccine are:
Vaccine Adverse Event Reporting System (VAERS), which is jointly operated with FDA and CDC; and
Vaccine Safety Datalink (VSD) Project.
Healthcare providers are encouraged to report clinically significant adverse events in persons who receive 2009 H1N1 influenza vaccine (as well as such events after any receiving any vaccine) by submitting a report to VAERS.
Information on submitting reports is available at www.vaers.hhs.gov .