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Extract from World Health Organization (WHO), CSR, Disease Outbreak News, Mon 4 Oct 2004 http://www.who.int/csr/don

Status of vaccine development for an influenza pandemic

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A vaccine could reduce the high morbidity and mortality normally associated with influenza pandemics, if available sufficiently early. Significant efforts are needed to expedite vaccine development to take advantage of this preventive option.

Progress is needed on 3 fronts. Firstly, countries experiencing outbreaks need to rapidly share human and animal viruses with laboratories in the WHO Global Influenza Surveillance Network. Analysis of these viruses determines the possible need for changes in the prototype vaccine "seed" strains which WHO makes available to the pharmaceutical industry.

Secondly, companies need to engage in research on pandemic vaccine development that includes pilot production of small batches for clinical testing. National licensing agencies in Europe and North America have developed regulatory guidelines for industry.

Thirdly, public health agencies need to engage in discussions with pharmaceutical companies to explore areas of common interest in vaccine development and to identify areas where support is needed. Since 2003, when 2 cases of human H5N1 infection occurred in Hong Kong, WHO has worked to identify and resolve problems in order to pave the way for rapid development and production of a pandemic vaccine.

Vaccine manufacturers respond to market forces. Companies may be reluctant to produce a vaccine for an event, such as a pandemic, that cannot be predicted with any certainty and might not be caused by currently circulating strains. Some uncertainty has also centered on rights to use the special technique of reverse genetics, a patented procedure, that is needed to produce the prototype "seed" vaccine against H5N1.

At the beginning of April 2004, WHO made the prototype seed strain for an H5N1 vaccine available to manufacturers. To date, only 2 of the world's roughly 12 major companies producing influenza vaccines have taken work on a pandemic vaccine significantly forward. These 2 companies, Aventis Pasteur Inc. and Chiron Corp., both located in the USA, have produced small batches of vaccine for use in clinical trials. These trials, which require several months for the compilation and analysis of data, are needed to fine-tune vaccine composition, test safety, and to meet other licensing requirements. Trials are not expected to begin before the end of the year [2004].

(This extract was taken from the ProMed mail website.)