September 2005 - Pharmaceutical Technology

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September 2005

Pharmaceutical Technology


VACCINES

US Government Orders 2M Doses of Avian Flu Vaccine

The US National Institute of Allergy and Infectious Diseases (NIAID, Bethesda, MD, http://www3.niaid.nih.gov/) announced it will order two million doses of an avian influenza vaccine from Sanofi-Pasteur (Swiftwater, PA and Lyon, France, http://www.sanofipasteur.com/). In April, the NIAID began a Phase I trial to evaluate the vaccine's safety and ability to generate immunity against the H5N1 strain of avian flu, an illness that leads to severe disease and possible death in birds and humans. The government also contracted with Chiron Corporation to make 10,000 doses of similar vaccines, but production has not begun because of contamination found previously in its Liverpool plant (see D. McCormick, "Chiron Continues; Compounding Crackdown," Pharm. Technol. 29 [2], 17 [2005]).

Though the first 115 volunteers of the study's 450 subjects exhibited a strong immune response to the vaccine, NIAID's director, Anthony S. Fauci, MD, cautioned in a recent New York Times article, "We don't have all the vaccine we need to meet the possible demand. The critical issue now is, can we make enough vaccine, given the well-known inability of the vaccine industry to make enough vaccines."

Mass production of flu vaccines has been a challenge for vaccine manufacturers because the supply of chicken eggs (in which the vaccine is made) is limited. To help speed production, the vaccine was developed by reverse genetics using a seed virus "for vaccine production in a matter of weeks, a process that usually requires several months," Fauci said in an article he prepared for The Washington Times in March. The lack of manufacturing capacity is another problem that makes mass production difficult. According to Fauci, the vaccine maker will manufacture flu vaccine in shifts, with next winter's flu vaccine production ending this month and the avian vaccine production beginning in mid-September at the earliest.

Studies will continue on the remaining 335 volunteers, and additional tests are needed to determine the appropriate dosage of the vaccine and whether dose-sparing techniques can be used to stretch available supplies. Though the vaccine is not ready for use by the general public, the government plans to stockpile the vaccine and distribute doses in the event of a US pandemic.

–Kaylynn Chiarello

MANUFACTURING

GSK Releases Flu Vaccine Production Strategies

GlaxoSmithKline (Uxbridge, UK, http://www.gsk.com/) is actively pursuing several strategies for meeting worldwide demand for the development, manufacture, and accessibility of flu vaccines.

As announced in the company's second-quarter report and at a vaccines seminar in June, the company is taking steps to boost its existing "Fluarix" flu vaccine production capacity. GSK also is continuing trials of an "improved" flu vaccine formulation, developing a new cell culture-based production system (for projected introduction in 2010), and preparing for a possible flu pandemic.

During the seminar, Bruce Innis, MD, GSK's vice-president of Clinical Research and Development and Medical Affairs for Vaccines for Virus Diseases, said the company plans to expand its Dresden, Germany facility to manufacture 35 million doses of Fluarix for the 2005–2006 season—up 5 million from 2004. Long-term plans include more than doubling Fluarix production to 80 million doses in the next three years.


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