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H1N1 Swine Flu Vaccines

What is the 2009 H1NI (swine flu) vaccine?

The Food and Drug Administration (FDA) recently approved the H1N1 vaccine as an injection and an intranasal spray made by CSL, Sanofi Pasteur, MedImmune and Novartis.

How are the H1N1 vaccines manufactured and are they safe?

The H1N1 vaccines are manufactured using the same vaccine manufacturing processes used for the regular seasonal flu vaccines and the H1N1 vaccines should be as safe and as effective as the regular seasonal flu vaccines.

What are the differences between the H1N1 and regular flu vaccine?

The difference between regular flu vaccines and H1N1 vaccines is the virus that is used in the manufacturing process. Regular flu vaccine does not contain components of the 2009 H1N1 virus. Regular flu vaccines do not protect against H1N1, and H1N1 vaccines will not protect against the regular flu.

Who should receive H1N1 flu vaccine?

The following groups should receive H1N1 vaccine as soon as possible:

  • Pregnant women because they are more likely to develop serious illness and death from H1N1
  • People who live with or care for infants younger than 6 months of age in order to prevent transmission of flu virus from caregivers to infants. Infants are susceptible to developing serious complications from the flu virus
  • Health care and emergency medical personnel because they are at risk for contracting the flu from sick patients and if infected may transmit the virus to patients
  • Anyone from 6 months through 24 years of age because individuals younger than 25 years of age have been infected more often than older people
  • Anyone from 25 through 64 years of age with certain chronic medical conditions or a weakened immune system because chronic conditions reduce the ability of the body to fight diseases

Other groups should be vaccinated as more vaccine becomes available.

What is the influenza A (H1N1) 2009 monovalent vaccine (inactivated injectable)?

Injectable H1N1 vaccines are manufactured by CSL, Sanofi Pasteur or Novartis. They are inactivated H1N1 virus vaccines used for immunization of individuals 6 months of age and older against influenza disease caused by H1N1 2009 virus. Injectable H1N1 vaccine will not cause influenza because the virus in it is inactivated though it still stimulates the immune system to form antibodies against the H1N1 virus.

What are risks of adverse events and side effects for the influenza A (H1N1) 2009 monovalent vaccine (inactivated injectable)?

The likelihood of the H1N1 vaccines causing serious harm is extremely small. The risk of adverse events from injectable H1N1 vaccine is similar to seasonal inactivated flu vaccine. Mild adverse events that usually begin shortly after administration and last 1-2 days include soreness, redness, tenderness, or swelling at the injection site, fainting (mainly adolescents), headache, muscle aches, fever, and nausea.

Rarely, some individuals may experience severe allergic reactions that present as difficulty breathing, hoarseness or wheezing, hives, paleness, weakness, a fast heart beat or dizziness. A doctor should be consulted immediately if such symptoms occur. Injectable H1N1 vaccine should not be administered to individuals hypersensitive to eggs or chicken protein (since the vaccine is manufactured in eggs) neomycin or polymyxin (antibiotics that are used in the production of the vaccine), or anyone who has had a life-threatening reaction to flu vaccination.

Who should receive more than one dose of the vaccine influenza A (H1N1) 2009 monovalent vaccine (live, intranasal spray)?

Individuals older than 10 years of age should receive a single shot while children nine years old and younger may require two shots one month apart. Injectable H1N1 vaccine may be adminstered to pregnant or breastfeeding women and also may be administered with other vaccines.

What is the influenza A (H1N1) 2009 monovalent vaccine (live, intranasal spray)?

The nasal spray vaccine is made with live, weakened viruses that cannot grow at normal body temperature. The H1N1 nasal spray vaccine is manufactured by MedImmune in the same way as the seasonal nasal spray vaccine (Flumist), but instead of containing three weakened live flu viruses, it contains weakened 2009 H1N1 flu virus.


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Who should and should not receive the influenza A (H1N1) 2009 monovalent vaccine (live, intranasal spray)?

Intranasal flu vaccine is used for prevention of the flu caused by H1N1 virus in healthy individuals 2 to 49 years of age. It should not be administered to people younger than 2 years or older than 50 years; pregnant women; those with chronic illnesses (for example, chronic heart or lung disease, diabetes or kidney failure); people with reduced immune function, or taking medications that weaken the immune system; and individuals allergic to chicken eggs or any of the components of the vaccine.

What are the side effects of the influenza A (H1N1) 2009 monovalent vaccine (live, intranasal spray)?

Side effects of intranasal vaccine can include runny nose, headache, wheezing, vomiting, muscle aches, fever, headache, sore throat, and cough.

Who should receive more than one dose of the vaccine influenza A (H1N1) 2009 monovalent vaccine (live, intranasal spray)?

Individuals 2-9 years of age require 2 doses while individuals 10 years and older require one dose of intranasal H1N1 vaccine.


CDC Questions & Answers: 2009 H1N1 Nasal Spray Vaccine

Influenza A (H1N1) 2009 Monovalent Vaccine (Novartis Vaccines and Diagnostics Limited), Prescribing Information

Influenza A (H1N1) 2009 Monovalent Vaccine (Sanofi Pasteur, Inc.), Prescribing Information

Influenza A (H1N1) 2009 Monovalent Vaccine (CSL Limited), Prescribing Information

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