Swine Flu Vaccine - Order out of Chaos


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Novartis begins shipment of swine flu vaccine to US
Business News
October 6, 2009

Geneva - Swiss drugmaker Novartis said Tuesday it has started shipping vaccines against the A(H1N1) virus, better known as swine flu, to the United States.

The company began sending doses last week from a production seed strain provided by the World Health Organization. This strain had a low yield, but Novartis said it has switched to a higher yielding one to allow for larger production volumes.

The Basel-based pharmaceutical giant also shipped 27 million doses of its seasonal flu vaccine ahead of schedule, in what it said was anticipation of 'demand for earlier vaccination with seasonal influenza vaccine created by the current global A(H1N1) influenza pandemic.'

The shipment was its largest ever to the US.
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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 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).
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