Pregnant Women & Manufacturer's Inserts for H1N1 Vaccine

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/Approv...

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/Approv...

“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/Approv...

“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/Approv...

“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/CommitteesMeetingMa...]

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.

Tags: H1N1, flu, medicine, pregnancy, swine, vaccines

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Great information and reasearch! Thanks!!!
Weigh the risk vs benefit. NO medications involve pregnant women in initial clinical trials. This vaccine is not made any differently than the regular flu vaccine. The regular flu vaccine has a very good safety track and has been used in pregnant women for years, with no signs of risk to mom or baby. Just think critically about this.
Most clinical trials include pregnant lab rats, while the H1N1 vaccine is being given to pregnant women before pregnant lab rats.

For what it's worth, vaccinating pregnant women has not reduced hospitalizations. A 1997-2002 study of 49,585 pregnant women there was no statistically significant difference in rates of illness among vaccinated vs. unvaccinated women (4.5/10,000 vs. 4.4/10,000). There were only two admissions per season for pneumonia.
[REF: Black SB, et al. Effectiveness of the influenza vaccine during pregnancy in preventing hospitalizations and outpatient visits for respiratory illness in pregnant women and their infants. Am J Perinatol 21:333-339. 2004.]

Reviewing all manufacturer package inserts, we can see that both seasonal flu shots and 2009 H1N1 flu shots are labeled “Pregnancy Category C” drugs, meaning:
* Animal reproduction studies have not been conducted.
* It is not known whether influenza vaccines can cause harm to the fetus.
* It is not know whether influenza vaccines can affect reproduction capacity.
* It is not known whether influenza viruses from vaccines are excreted in human milk.

Also from referencing package inserts, we learn that both Tamiflu (oseltamivir) and Relenza (zanamivir) are classified as "Pregnancy Category C" drugs, meaning, there is insufficient information to assess potential risks to the fetus; and also that in lactating rats, Tamiflu was excreted in the milk. It is not known whether Tamiflu is excreted in human milk.
In response to MB's comment

"Weigh the risk vs benefit. NO medications involve pregnant women in initial clinical trials. This vaccine is not made any differently than the regular flu vaccine. The regular flu vaccine has a very good safety track and has been used in pregnant women for years, with no signs of risk to mom or baby. Just think critically about this."

Yes but shouldn't they if they are going to really PUSH them with pregnant women? I think so.

If they can't tell me it's safe, and yet they are telling me to take it then those in power aren't doing their jobs. I can honestly say I believe that they are more concerned with using up the 250 million contracted vaccines then the casualties along the way. Unacceptable.
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]
It should be noted that this holds true for nursing mothers as well. There is a mistake on the CDC webpage for H1N1:

The CDC encourages nursing mothers to receive the vaccine either by the shot or the SPRAY. This is against the manufacturer warnings. The CDC is advising this without scientific basis.

The CDC, on the same page, also encourages new mothers to receive the vaccine either by the shot or the SPRAY. This recommendation is made without fully informing parents...the nasal spray is a live-attenuated viral spray that can be contagious for 21 days, with the average length being 8 days. If the parents receive the nasal spray, they can be direct transmittors of the disease to the newborn.
Excellent information! Thank you so much for posting that.

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