Influenza A (H1N1) 2009 Monovalent Vaccine - influenza A/California/7/2009 (H1N1)v-like virus vaccine; monovalent pandemic (H1N1) 2009 influenza vaccine; swine flu vaccine
Status: supplemental BLA approved in Sept. 2009; acquired by the U.S. government for the 2009/10 flu season; different but very similar vaccine used in Europe
Organizations involved:
Novartis Vaccines and Diagnostics Ltd. – Manuf; R&D; Tech.;World mark.
Novartis Pharmaceutical Corp. – USA mark.
Novartis AG – Parent
Centers for Disease Control and Prevention (CDC) – USA mark. [to public health programs]
Cross ref.: See the Influenza H1N1 Vaccine Products and Influenza Vaccine Products entries. See the entry for Focetria (H1N1) for the European and international version of this vaccine, essentially this same vaccine but with MF59 adjuvant (not approved in the U.S.).
Description: Influenza A (H1N1) 2009 Monovalent Vaccine from Novartis is an aqueous subunit split (purified surface antigen) formulation of influenza A/California/7/2009 (H1N1)v-like virus cultured in embryonated hens’ eggs, inactivated with beta-propiolactone (BPL) and disrupted (split with nonylphenol ethoxylate. An analogous vaccine, Focetria (H1N1), is approved in the European Union, with the major difference being that this contains MF59 adjuvant.
The virus is conventionally cultured in the allantoic cavity of embryonated hens’ eggs inoculated with influenza A/California/7/2009 (H1N1)v-like virus suspension containing neomycin and polymyxin. The influenza virus strain is harvested and clarified by centrifugation and filtration prior to inactivation with beta-propiolactone. The inactivated virus is concentrated and purified by zonal centrifugation. The virues are disrupted and surface antigens, hemagglutinin and neuraminidase, are obtained from the influenza virus particle by further centrifugation in the presence of nonylphenol ethoxylate (a detergent), which removes most of the internal proteins. The nonylphenol ethoxylate is later removed from the surface antigen preparation.
Influenza A (H1N1) 2009 Monovalent Vaccine is formulated to contain 15 µg hemagglutinin (HA) per 0.5-mL dose of A/California/7/2009 (H1N1)v-like virus.
The vaccine is packaged in prefilled single dose syringes and multi-dose vials. The syringed contain 0.5-mL. Thimerosal (mercury derivative; see related entry) is used during manufacture, but is removed by subsequent purification steps to a trace amount (≤ 1 µg mercury per 0.5-mL dose), and the vaccine is often cited as being "thimerosal-free."
The 5-mL 10-dose vial formulation contains thimerosal added as an antimicrobial preservative. Each 0.5-mL dose from the multidose vial contains 25 µg mercury.
Each dose from the multidose vial or from the prefilled syringe may also contain residual amounts of egg proteins (≤ 1 µg ovalbumin), polymyxin (≤ 3.75 µg), neomycin (≤ 2.5 ≤g), beta-propiolactone (not more than 0.5 µg) and nonylphenol ethoxylate (not more than 0.015% w/v).
Nomenclature: Influenza vaccine, H1N1/Novartis [BIO]; Influenza A (H1N1) 2009 Monovalent Vaccine [FDA]; influenza A/California/7/2009 (H1N1)v-like virus vaccine {SY]; monovalent pandemic (H1N1) 2009 influenza vaccine [SY]; swine flu vaccine [SY]
NDC 66521-200-02; NDC 66521-200-10 [NDC]
Companies.: In July 2009, Novartis received an order from the Centers for Disease Control and Prevention (CDC) for $346 million of bulk antigen and $343.8 million of MF59 adjuvant totalling $690 million. If needed, the government plans to contract for further formualtion, finishing and packaging of vaccine, either nonadjuvants or adjuvanted (if a truely serious emergency situation develops). Vaccine will also be distributed through normal private s
FDA class: Biologic BLA
Approvals: Date = 20090915; sBLA; approval letter reports BLA supplement BL 103837/5514 (while the product insert at the FDA Web site is inexplicably labeled with "BLA 1750")
Status: On Sept. 15, 2009, FDA granted this H1N1 vaccine (and 3 others) supplemental BLA approval, based on the presumption that the vaccine is substantially similar, including manufacturing process and specifications, to the comparable Novartis seasonal vaccine, Fluvirin, except for being monovalent and using an H1N1 strain.
Novartis began deliveries of vaccine to the CDC in the U.S. in Oct. 2009.
Indications: [Full text of the "Indications and USAGE" section of the product insert/labeling];
Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons 4 years of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.
Trials: Clinical trials suggest that just one dose of this vaccine with MF59 adjuvant can protect healthy adults, which means that the vaccine can be provided to twice the number of people than if two doses were needed.
Medical: Since they have never encounted this strain before, children 4 through 9 years of age receive two 0.5-mL intramuscular injections ~1 month apart. Children ten year of age and older and adults receive a single 0.5-mL intramuscular injection.
Market: As with most H1N1 vaccines, most finished doses were being purchased by governments worldwide, generally at around $10/dose.
The author's crude estimate for total 2009 (2009/10 flu season) worldwide sales of finished vaccine and bulk vaccine and adjuvant sales to governments is $750-900 million,
Companies involvement:
Full monograph
483.3 Influenza vaccine, H1N1/Novartis
Nomenclature:
Influenza vaccine, H1N1/Novartis [BIO]
Influenza A (H1N1) 2009 Monovalent Vaccine [FDA]
H1N1 2009 influenza vaccine [SY]
influenza A/California/7/2009 (H1N1)v-like virus vaccine [SY]
monovalent pandemic (H1N1) 2009 influenza vaccine [SY]
swine flu vaccine [SY]
NDC 66521-200-02; NDC 66521-200-10 [NDC]
FDA Class: sBLA
Year of approval (FDA) = 2009
Date of 1st FDA approval = 20090915
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
chicken source materials
nonoxynol 101 (Triton N101)
vaccines, inactivated
vaccines, subunit
vaccines, viral
chicken embryo (egg) culture
infertility treatment
influenza virus
virus culture
beta-propiolactone (BPL; beta propiolactone)
Edmonston strain, measles virus
hemagglutinin (HA) antigen, influenza A virus
neomycin
nonoxynol 101 (Triton N101)
osteoarthritis
polymyxin
sodium succinate
thimerosal (mercury derivative)
EU000 Not yet/Never filed with EU
UM100 Controlled/Gov't Distribution in US
US000 never filed/no plans
EM999 Not Available/Not Marketed in EU
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