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news.BioDiem, an Australian biopharmaceutical development company, has provided an update on the Pandemic Influenza Vaccine Program with the World Health Organisation (WHO).
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Earlier, in September 2009, the World Health Organisation has entered into two sublicences, under its Global Pandemic Influenza Action Plan for developing countries, with the Government Pharmaceutical Organisation of Thailand (GPO) and the Serum Institute of India (SII).
In October the WHO had signed a further sublicence with Zhejiang Tianyuan Bio-Pharmaceutical. These agreements authorise egg-based manufacturing and distribution of influenza vaccines, made using BioDiem’s LAIV technology, in the public sector of these countries.
The Institute of Experimental Medicine (IEM) in St Petersburg, Russia produced influenza reassortants using the wild-type H1N1 California vaccine strain for the development of a pandemic influenza vaccine.
In accordance with the WHO agreement, the IEM supplied these reassortants to the GPO in Thailand and the SII in India and these companies prepared experimental batches for preclinical and clinical studies in December 2009. Batches of these vaccines were sent to Viroclinic in The Netherlands and were tested in ferrets for quality and efficacy. The results confirmed that they were similar to the Russian product, which has been extensively used in that market for many years.
Reportedly, the Government Pharmaceutical Organisation in Thailand has completed a Phase I clinical trial in healthy adults of its candidate vaccine and it was shown to be safe. The GPO is expected to commence a Phase II clinical trial in April 2010.
Additionally, the Serum Institute of India has also successfully completed a Phase I trial and safety was shown. A Phase II/III clinical trial is now in progress. Subject to results, the vaccine is expected to be ready for public use in April-May this year.
Larisa Rudenko, head of the virology department in the institute of experimental medicine at St Petersburg and director of BioDiem, said: “In the event of an influenza pandemic we need to protect not only the developed countries but also those in developing countries with their vast and often crowded populations, which can only lead to higher infection rates.
“The majority of highly virulent influenza viruses emanate from these countries. Our LAIV technology will accelerate production and increase yield of pandemic vaccine supplies.”