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sábado, 31 de julio de 2010
Lot Release (Biologics) > 2010-2011 Vaccine Influenza Season Questions and Answers
2010-2011 Vaccine Influenza Season Questions and Answers
1. Vaccines for the 2010-2011 influenza season are approved by FDA for the prevention of influenza in children, adolescents, and adults, including the elderly. There are several vaccines approved by FDA available in both nasal spray and injectable (a “shot”) forms.
2. Because the influenza viruses that cause people to get sick can change, each year's vaccine may be different from the previous year. Therefore, it is important to get the influenza vaccine every year.
3. The vaccines approved by FDA to protect against influenza have a long and successful track record of safety and effectiveness in the United States.
4. Influenza or “the flu” is a contagious respiratory illness caused by influenza viruses. It is a serious threat to public health and can cause mild to severe illness, and at times can lead to death.
5. The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) recommends that everyone 6 months of age and older receive the influenza vaccine every year.
6. The 2010-2011 seasonal influenza vaccine includes three strains; an A (H1N1) that is the same strain that is the cause of the pandemic that began in 2009, an A (H3N2) that is different than last year’s seasonal vaccine and a B strain that is the same as last year’s formulation.
7. This year, two different vaccines are not needed, only one. During last year’s influenza season, two different vaccines were needed; one to prevent seasonal influenza and another to prevent influenza that is the cause of the 2009 (H1N1) pandemic.
8. Each year there are two flu seasons due to the occurrence of influenza at different times in the Northern and Southern Hemispheres. Some influenza vaccine manufacturers produce vaccines for use in both the Northern Hemisphere and the Southern Hemisphere. The Southern Hemisphere vaccines are similar but not identical to the vaccines used in the Northern Hemisphere, which include the U.S. licensed vaccines.
9. In Australia and New Zealand, use of the 2010 Southern Hemisphere formulation of one influenza vaccine, manufactured by CSL Limited, has been associated with an increased incidence of fever and febrile seizure among young children, mainly among those less than 5 years of age. Therefore, the Warnings and Precautions section of the Prescribing Information for Afluria, the U.S. licensed Northern Hemisphere formulation made by CSL Limited, has been changed to include a statement to inform healthcare providers about the occurrence of these events.
10. The available data suggest that the increased rates of fever and febrile seizure in those children mainly less than 5 years of age, are only associated with the Southern Hemisphere formulation of CSL’s vaccine. The available data regarding the safety of other influenza vaccines for children used in the Southern Hemisphere do not suggest an increased rate of fever or febrile seizure.
11. FDA, in collaboration with CDC, will closely monitor the continued safety of all influenza vaccines.
What strains are included in the 2010-2011 seasonal influenza vaccine?
Each year, influenza infections are caused by Influenza A and Influenza B viruses. Three strains of influenza virus that cause people to get sick are included in the vaccine each year, a representative strain of Influenza A (H1N1), Influenza A (H3N2) and Influenza B. Because the influenza viruses that cause people to get sick can change, each year's vaccine may be different from the previous year.
This year, the B strain remains the same as last year’s seasonal vaccine, but the H1N1 and H3N2 strains are different. However, the H1N1 strain in this year’s vaccine is the same strain as the pandemic (H1N1) 2009 influenza virus.
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