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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2010-2011 Influenza Season Vaccine Questions and Answers

Key Facts

  • 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.
  • 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.
  • The vaccines approved by FDA to protect against influenza have a long and successful track record of safety and effectiveness in the United States.
  • 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.
  • 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.
  • 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.  
  • 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.   
  • 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. 
  • 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. 
  • 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.
  • FDA, in collaboration with CDC, will closely monitor the continued safety of all influenza vaccines.
  • The recent August, 2010, salmonella outbreak in shell eggs for food consumption and subsequent recall does not affect 2010-2011 Influenza Virus Vaccine production, safety or availability.  The eggs used for influenza vaccine production are different from eggs that are used for food consumption in that they are embryonated.  The Influenza Virus Vaccine undergoes extensive testing and the vaccine manufacturing process is highly regulated under FDA's current good manufacturing practice requirements, including annual inspections of the manufacturing processes and facilities.

Detailed Information:

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.  

Why should I get the influenza vaccine?

Influenza or “the flu” is a contagious respiratory illness caused by influenza viruses and occurs most often in the winter and spring.  It is a serious threat to public health and can cause mild to severe illness, and at times can lead to death.  Although no vaccine is 100% effective against preventing disease, vaccination is the best protection against influenza and can prevent many illnesses and deaths.  The best time to get the vaccine is in the fall before influenza viruses start to circulate, but getting it anytime throughout the winter months when flu season often peaks is also recommended.

What are the available forms of influenza vaccine?

FDA has licensed two forms of influenza vaccine for use in the United States:  the inactivated vaccine (sometimes called the "flu shot") and the live attenuated vaccine, which is a nasal spray. 

The inactivated vaccine contains inactivated, or killed, virus and is given with a needle in the arm.  The nasal spray vaccine contains live viruses that are weakened, or attenuated, and is administered into the nose with a nasal sprayer. 

Neither vaccine will cause influenza. 

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) provides annual recommendations for the prevention and control of influenza, including use of vaccines.  As of this year, they recommend that everyone in the United States 6 months of age and older receive the seasonal influenza vaccine.

What vaccines are available for the 2010-2011 influenza season? 

The following vaccines will be available for adults:

  • Afluria
manufactured by CSL Limited
  • Agriflu
manufactured by Novartis Vaccines and Diagnostics
  • Fluarix
manufactured by GlaxoSmithKline Biologicals
  • FluLaval
manufactured by ID Biomedical Corporation
  • FluMist
for adults up to age 49 years of age, manufactured by MedImmune
  • Fluvirin
manufactured by Novartis Vaccines and Diagnostics
  • Fluzone
manufactured by sanofi pasteur Inc.
  • Fluzone High-Dose
specifically for the elderly population 65 years of age and older, manufactured by sanofi pasteur Inc.

The following vaccines will be available for children: 

  • Afluria
manufactured by CSL Limited
  • Fluarix
manufactured by GlaxoSmithKline Biologicals
  • FluMist
manufactured by MedImmune
  • Fluzone
manufactured by sanofi pasteur Inc.
  • Fluvirin
manufactured by Novartis Vaccines and Diagnostics

Why is the H1N1 strain that caused the 2009 pandemic included in the 2010-2011 seasonal vaccine?

The strains that are included in the 2010-2011 seasonal influenza vaccine are based on a review of information gathered from the strains of flu viruses that infected people around the world during the previous year, how they have changed, as well as disease trends.  All of this information is used to forecast which viruses are likely to circulate in the United States in the upcoming influenza season.  This season’s vaccine contains three influenza strains.  One of the three is the H1N1 strain that is the cause of the 2009 pandemic because it still continues to infect people.

Is only one vaccine needed this year?

Yes.  Last year the pandemic influenza virus emerged after the seasonal influenza vaccine was made, so an additional vaccine was needed for the new influenza virus that caused the pandemic.

Do I need to get influenza vaccine again this year?

Yes, influenza viruses can change from year-to year, so it is important to get the vaccine every year for the new influenza season.

Some years the vaccine may not exactly match the influenza viruses that cause disease in people, but it does not mean that the vaccine is not benefiting people.  It can still be helpful by causing milder illness, preventing flu-related complications, and by providing some protection over following years. 

Since the 2009 H1N1 pandemic influenza strain is included in this year’s seasonal vaccine, if I already received the vaccine during the pandemic, is it okay to get it again?

In addition to the H1N1 strain, the vaccine also contains an influenza B strain and a new influenza H3N2 strain, so the vaccine is needed to protect against these additional influenza viruses which are predicted to cause illness this year.  Receiving the H1N1 strain again, in the context of this year’s new seasonal vaccine, is important to continue protection against this particular strain.  

Why was the Warnings and Precautions section of the prescribing information changed for Afluria?

Southern Hemisphere countries are currently experiencing their 2010 influenza season. 
An increased number of fevers and febrile seizures have been reported in children, predominantly among those less than 5 years of age, following administration of the influenza vaccine manufactured by CSL Limited, which is approved as Afluria in the United States.

The Warnings and Precautions section of Afluria’s prescribing information has been revised to include a statement to inform healthcare providers about this increased incidence of fever and febrile seizures in young children, mainly less than 5 years of age, following administration of the Southern Hemisphere formulation of CSL’s influenza vaccine.  This change is based on information gathered after the vaccine was given in Australia and New Zealand.
Various investigations into the cause(s) of these febrile seizures are still ongoing. FDA is collaborating with Australia’s regulatory authority (Therapeutic Goods Administration), other international regulatory counterparts, and CSL to obtain additional information, stay apprised and take part in the investigations.
What are “Warnings and Precautions” in vaccine labeling?

A Warning or Precaution is added to the labeling of a vaccine to make the healthcare provider aware of important information, such as a potential adverse event and to advise the health care provider how to use the vaccine most safely and effectively.

Will Afluria still be available in the United States?

Yes, although the manufacturer will not be supplying the 0.25 mL presentation to the United States that is used in children 6 months – 35 months of age, the 0.5 mL single dose, prefilled syringe and 5 mL multi-dose vial presentation will be distributed.  The Indications and Usage section of the prescribing information has not changed.

Specific recommendations for the use of Afluria will be made by the ACIP.

Does this change to Afluria’s Prescribing Information also affect other seasonal influenza vaccines? 

No.  The available data regarding the safety of other childhood influenza vaccines used in the Southern Hemisphere do not suggest an increased rate of fever or febrile seizures in children less than five years of age.

What other seasonal influenza vaccines are approved by FDA specifically for use in children?

  • Fluarix, manufactured by GlaxoSmithKline Biologicals, is approved for use in individuals 3 years of age and older
  • FluMist, manufactured by MedImmune, is approved for use in individuals 2-49 years of age
  • Fluvirin, manufactured by Novartis Vaccines and Diagnostics, is approved for use in individuals 4 years of age and older
  • Fluzone, manufactured by sanofi pasteur, is approved for use in individuals 6 months of age and older

Were there similar reports of adverse events for the other influenza vaccines?

FDA has contacted all of the manufacturers who are licensed by FDA to produce inactivated influenza vaccines for the United States for information about adverse events in pediatric populations for any seasonal 2010 trivalent influenza vaccine distributed in the Southern Hemisphere.  Included in the request was information about: febrile reactions, febrile seizures, and all seizure events from clinical studies and/or commercial distribution.  

GlaxoSmithKline and Novartis did not supply influenza vaccine to the Southern Hemisphere for the 2010 influenza season.  Sanofi pasteur supplied the Southern Hemisphere 2010 formulation of its U.S.–licensed vaccine, Fluzone, to Brazil.  They also distribute a vaccine that is not licensed in the United States (Vaxigrip) in Australia, New Zealand and other Southern Hemisphere countries.  We are not aware of reports of febrile seizures in young children from countries using either of these vaccines.   

What are febrile seizures?

Febrile means "relating to a fever” or an unusually high body temperature.  In some children, having a fever can cause a seizure.  During a febrile seizure, a child often has spasms or jerking movements and may lose consciousness.

Although febrile seizures can be frightening for the child's caregivers, most are harmless.  The majority of children who have febrile seizures recover quickly and have no lasting effects. Nearly one-half of children who have one febrile seizure will have at least one more.

Approximately 1 in 25 (4%) young children will have at least one febrile seizure, usually between 6 months and 5 years of age.  The peak age for febrile seizures is 18 and 24 months of age.

Febrile seizures usually last only a minute or two.  They are most common with fevers that go up fast and reach 102° F (38.9° C) or higher, but can also occur when a fever is going back down.  Febrile seizures may happen with any condition that causes a fever, including common childhood illnesses like ear infections and viral infections, such as influenza or roseola and sometimes vaccinations.

If a member of a child's immediate family has febrile seizures, that child is more likely to have a febrile seizure.

What are FDA’s plans to monitor the safety of Afluria and other seasonal influenza vaccines?

FDA has requested additional data from Australia’s Therapeutic Goods Administration and New Zealand, and is working with the Pan American Health Organization (PAHO) and CDC to gather additional information on febrile seizures following use of 2010 seasonal formulations of influenza vaccines in other countries in the Southern Hemisphere.

Additionally, FDA is requiring CSL Limited to conduct a study of Afluria in children to obtain additional information regarding the febrile events that were seen in the Southern Hemisphere.
Furthermore, as with all vaccines, FDA in collaboration with CDC, will continue to monitor adverse events associated with the administration of vaccines and reported to the Vaccine Adverse Event Reporting System (VAERS). VAERS is a program created as an outgrowth of the National Childhood Vaccine Injury Act of 1986 (NCVIA) and is administered by FDA and CDC. VAERS accepts reports of adverse events that may be associated with U.S. licensed vaccines from health care providers, manufacturers, and the public. FDA and CDC continually monitor VAERS reports for any unexpected patterns or changes in reporting rates of adverse events.