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Package inserts for Novartis's swine flu jab (below) show that the companies knows very well there is no clinical data on whether "Influenza A (H1N1) 2009 Monovalent Vaccine or FLUVIRIN can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity."

It is not clear why no clinical trials have been carried out on pregnant women to establish this data since they are a target group and have been for months.

One possibility is that Novartis knows that any clinical trials will reveal that the swine flu jab does cause especial harm to pregnant women and children.

By not conducting the trials, Novartis can imply they are safe when there is no such safety data.


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

8.1 Pregnancy 

Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or FLUVIRIN. It is also not known whether Influenza A (H1N1) 2009 Monovalent Vaccine or FLUVIRIN can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Influenza A (H1N1) 2009 Monovalent Vaccine should be given to a pregnant woman only if clearly needed. 

8.3 Nursing Mothers 

It is not known whether FLUVIRIN or Influenza A (H1N1) 2009 Monovalent Vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Influenza A (H1N1) 2009 Monovalent Vaccine is administered to a nursing woman. 

8.4 Pediatric Use 

Safety and effectiveness in pediatric subjects below the age of 4 years have not been established. [see ADVERSE REACTIONS (6) and CLINICAL STUDIES (14)] 

8.5 Geriatric Use 

Since 1997, of the total number of geriatric subjects (n = 397) in clinical studies of FLUVIRIN, 29% of adult subjects were 65 years and over, while 2.1% were 75 years and over.

Antibody responses were lower in the geriatric population than in younger subjects. Adverse events occurred less frequently in geriatric subjects (≥65 years) than in younger adults. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. [See ADVERSE REACTION (6) and CLINICAL STUDIES (14)]. 

11 DESCRIPTION 

Influenza A (H1N1) 2009 Monovalent Vaccine is a sub-unit (purified surface antigen) influenza virus vaccine prepared from virus propagated in the allantoic cavity of embryonated hens’ eggs inoculated with a specific type of influenza virus suspension containing neomycin and polymyxin. The influenza virus strain is harvested and clarified by centrifugation and filtration prior to inactivation with betapropiolactone. The inactivated virus is concentrated and purified by zonal centrifugation. The surface antigens, hemagglutinin and neuraminidase, are obtained from the influenza virus particle by further centrifugation in the presence of nonylphenol ethoxylate, a process which

Vial and Syringe leaflet text Page 12 of 20Novartis Vaccines and Diagnostics Limited BLA 1750 September 2009

removes most of the internal proteins. The nonylphenol ethoxylate is removed from the surface antigen preparation.

Influenza A (H1N1) 2009 Monovalent Vaccine is a homogenized, sterile, slightly opalescent suspension in a phosphate buffered saline. Influenza A (H1N1) 2009 Monovalent Vaccine is formulated to contain 15 mcg hemagglutinin (HA) per 0.5-mL dose of the following virus strain: A/California/7/2009 (H1N1)v-like virus.

The 0.5-mL prefilled syringe presentation is formulated without preservative. Thimerosal, a mercury derivative used during manufacturing, is removed by subsequent purification steps to a trace amount (≤ 1 mcg mercury per 0.5-mL dose).

The 5-mL multidose vial formulation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5-mL dose from the multidose vial contains 25 mcg mercury.

Each dose from the multidose vial or from the prefilled syringe may also contain residual amounts of egg proteins (≤ 1 mcg ovalbumin), polymyxin (≤ 3.75 mcg), neomycin (≤ 2.5 mcg), betapropiolactone (not more than 0.5 mcg) and nonylphenol ethoxylate (not more than 0.015% w/v).

The multidose vial stopper and the syringe stopper/plunger do not contain latex. 

DOSAGE FORMS AND STRENGTHS 

Influenza A (H1N1) 2009 Monovalent Vaccine, a sterile suspension for intramuscular injection, is supplied in two presentations: • Prefilled single dose syringe, 0.5-mL. Thimerosal, a mercury derivative used during

manufacture, is removed by subsequent purification steps to a trace amount (≤ 1 mcg

mercury per 0.5-mL dose) (3, 11) • Multidose vial, 5-mL. Contains thimerosal, a mercury derivative (25 mcg mercury

per 0.5-mL dose). Thimerosal is added as preservative. (3,11) 

CONTRAINDICATIONS 

• History of systemic hypersensitivity reactions to egg proteins, or any other component of Influenza A (H1N1) 2009 Monovalent Vaccine, or life-threatening reactions to previous influenza vaccinations. (4, 11) 

WARNINGS AND PRECAUTIONS 

• If Guillain-BarrĂ© syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give Influenza A (H1N1) 2009 Monovalent Vaccine should be based on careful consideration of the potential benefits and risks. (5.1)

• Immunocompromised persons may have a reduced immune response to Influenza A (H1N1) 2009 Monovalent Vaccine. (5.2) 

ADVERSE REACTIONS

Adverse Reaction information is based on studies conducted with seasonal trivalent Influenza Virus Vaccine manufactured by Novartis (FLUVIRIN).

Vial and Syringe leaflet text Page 1 of 20Novartis Vaccines and Diagnostics Limited BLA 1750 September 2009

The most frequently reported adverse reactions are mild hypersensitivity reactions (such as rash), local reactions at the injection site, and influenza-like symptoms.

To report SUSPECTED ADVERSE REACTIONS contact:
Novartis Vaccines at 1- 800-244-7668
VAERS at 1-800-822-7967
www.vaers.hhs.gov


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