Tuesday, November 03, 2009

Cell Based H1N1 Vaccine versus the Chicken Egg

Trial of Influenza A (H1N1) 2009 Monovalent MF59-Adjuvanted Vaccine — Preliminary Report

In this preliminary report, we present the clinical-event and immunogenicity profiles of the 7.5-µg dose of the monovalent influenza A/California/2009 (H1N1) MF59-adjuvanted surface-antigen vaccine, derived from cell culture, administered to adults 18 to 50 years of age. Two doses of the vaccine were either given concurrently, one in each arm, on day 0 or one dose was given on day 0 and the other on day 7 or 14. We will update this report with findings from subjects given two doses of 3.75 µg or 7.5 µg of MF59-adjuvanted vaccine, or 7.5 µg or 15 µg of nonadjuvanted vaccine, given 21 days apart, once these data are available.


The 2009 H1N1 vaccine virus (New York Medical College [NYMC] X-179A) was generated from the influenza A/California/7/2009 strain with the use of classical reassortant methods. The gene segments encoding the hemagglutinin, neuraminidase, and the polymerase PB1 were derived from the influenza A/California/7/2009 strain, with the remaining genes taken from the influenza A/PR8/8/34 virus used as a backbone for influenza vaccines. The strain was supplied by the Centers for Disease Control and Prevention and is a pandemic vaccine strain recommended for use in vaccine development. The seed virus was grown in Madin–Darby Canine Kidney (MDCK) cell culture by means of standard processes similar to those used for the development of Optaflu vaccines against interpandemic influenza. The vaccine was formulated and produced by Novartis (Marburg, Germany) as an inactivated surface-antigen H1N1 vaccine, with or without MF59 adjuvant, and supplied in 0.5-ml prefilled single-dose syringes. Each MF59-adjuvanted vaccine contained 7.5 µg of H1 hemagglutinin, 9.75 mg of the squalene MF59, 1.175 mg of polysorbate 80, and 1.175 mg of sorbitan trioleate in buffer. Each nonadjuvanted vaccine contained 15 µg of H1 hemagglutinin in buffer. Hemagglutinin content in the final vaccine was determined by means of reverse-phase high-performance liquid chromatography, because single-radial diffusion reagents were unavailable. Vaccine was stored at 4°C until use.

(emphasis added)

However, with the above information that shows the cell-culture process being used to produce the seed virus in MDCK, the news continues to push this.

VALHALLA - Most of the world's H1N1 vaccine started in 30 chicken eggs kept here in a warren of cluttered labs at New York Medical College.

Working seven days a week, microbiologist Doris Bucher and her eight assistants made "seeds" that manufacturers around the globe are using to grow the vaccine used in the swine flu shot.

"It was very intense," Bucher said. "We all knew how important...

The story talks about the [NYMC] X-179A being produced from chicken eggs when it clearly wasn't. It originated from a seed strain that was developed in Europe via the cell culture.

The story then leads you to believe the New York Medical College was where the vaccine started. That is clearly untrue.

This idea that the H1N1 vaccine is being produced using chicken eggs is misleading and was used by the Obama administration as an excuse for the delay in the production of the H1N1 vaccine.

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