H1N1 Vaccine Information

Here is some information that I have found helpful in my research regarding H1N1.

Below is information from the manufacturer’s inserts for the H1N1 vaccine, which can be found on the package inserts from each company for the vaccines. The links for these package inserts are listed as well.

All manufactured H1N1 vaccines contain thimerosal (ethyl mercury) except the LiveNasal spray manufactured by Medimune, “the safety and effectiveness of which have not been studied in pregnant or nursing mothers”.

Sanofi Pasteur Vaccine
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182404.pdf

“Safety and effectiveness of [the vaccine] have not been established in pregnant women or nursing mothers or children <6 months of age”

Novartis Vaccines
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182242.pdf

“Safety and effectiveness of [the vaccine] have not been established in pregnant women, nursing mothers or children less than 4 years of age.”

CSL Biotherapies
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182401.pdf

“Safety and effectiveness of [the vaccine] have not been established in pregnant women, nursing mothers or in persons less than 18 years of age.”

“Neither Influenza A (H1N1) 2009 Monovalent Vaccine nor AFLURIA has been evaluated in children. Safety and effectiveness in the pediatric population have not been established.”

Medimmune, LLC (Live Nasal)
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182406.pdf

“Do not administer [the vaccine] to children <24 months of age because of increased risk of hospitalization and wheezing.”

The Seasonal Influenza Vaccine

In Children:

In a recent master study that analyzed all relevant influenza vaccine studies during the past 40 years, researchers found that in healthy children older than 2 years of age, the live flu vaccine was just 33% effective; the inactivated vaccine was just 36% effective. [The Cochrane Collaboration, 2006]

In a recent master study published in The Lancet, researchers found no evidence that influenza vaccines prevent flu in children younger than 2 years old. [The Lancet, February 2005]

In healthy adults:

In a recent master study that analyzed all relevant influenza vaccines during the past 40 years, researchers found that in healthy adults under 65 years of age, flu vaccination did not affect hospital stay, time off from work, or death from from influenza and its complications. Authors of the master study concluded that “universal immunization of healthy adults is not supported” by data. [The Cochrane Collaboration, 2004].

In the Elderly:

In a recent master study that analyzed all relevant influenza vaccine studies during the past 40 years, researchers found that for elderly people living in the community, influenza vaccines were not effective. For elderly people living in group homes, influenza vaccines were found to be 46% effective against pneumonia, but non-significant against influenza.

In October 2006 the British Medical Journal published a paper that analyzed all pertinent influenza vaccination studies and found that flu vaccines had little or no effect on influenza campaign objectives, such as hospital stay, time off work, or death from influenza and its complications.

[Credit: http://thinktwice.com/flu_show.htm]

Below is information from the manufacturer’s inserts for the H1N1 vaccine, which can be found on the package inserts from each company for the vaccines. The links for these package inserts are listed as well.

All manufactured H1N1 vaccines contain thimerosal (ethyl mercury) except the LiveNasal spray manufactured by Medimune, “the safety and effectiveness of which have not been studied in pregnant or nursing mothers”.

All of the vaccine manufacturer’s inserts state that:

“Animal reproduction studies have not been conducted with [the vaccine]. It is also not known whether [the vaccine] can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. [The vaccine] should be given to a pregnant woman only if clearly needed.”

Sanofi Pasteur Vaccine
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182404.pdf

The Sanofi Pasteur vaccine contains formaldehyde.

“Safety and effectiveness of [the vaccine] have not been established in pregnant women or nursing mothers or children <6 months of age.”

Note that the “immune response and safety of Fluzone vaccine was evaluated in 31 children between the ages of 6-26 months.”

Novartis Vaccines
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182242.pdf

“Safety and effectiveness of [the vaccine] have not been established in pregnant women, nursing mothers or children less than 4 years of age.”

CSL Biotherapies
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182401.pdf

“Safety and effectiveness of [the vaccine] have not been established in pregnant women, nursing mothers or in persons less than 18 years of age.”

“Neither Influenza A (H1N1) 2009 Monovalent Vaccine nor AFLURIA has been evaluated in children. Safety and effectiveness in the pediatric population have not been established.”

“Neither Influenza A (H1N1) 2009 Monovalent Vaccine nor AFLURIA has been evaluated for carcinogenic or mutagenic potential or for impairment of fertility.”

Medimmune, LLC (Live Nasal)
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182406.pdf

“Safety and effectiveness of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal have not been studied in pregnant women or nursing mothers.”

“It is not known whether [the vaccine] can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.”

“Do not administer [the vaccine] to children <24 months of age because of increased risk of hospitalization and wheezing.”

Note: the Sanofi Pasteur H1N1 (injectable) vaccine is the one that is recommended by the manufacturer for children ages 6 months and up. You will note the insert states that the “immune response and safety of Fluzone vaccine was evaluated in 31 children between the ages of 6-26 months.”

The immune response and safety of the four vaccines were evaluated in only a few hundred children and adults for only 1-3 weeks prior to the release of the vaccines for public use. [Source: www.NVIC.org, http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM172424.pdf]

These studies are not published in the vaccine inserts because the studies had not been completed at the time the inserts were compiled. This is why the only information in the inserts regarding use of the vaccine for “specific populations” is for the H1N1 vaccine’s seasonal influenza likeness. In the case of the Sanofi Pasteur H1N1 vaccine it is the Fluzone seasonal influenza vaccine, which is made by the same process as the H1N1 vaccine.