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Following the World Health Organization's declaration last week of an influenza pandemic, vaccine makers in Europe and China as well as world health agencies are stepping up efforts toward rapid development and approval of an effective vaccine.
Following the World Health Organization’s declaration last week of an influenza pandemic, vaccine makers in Europe and China as well as world health agencies are stepping up efforts toward rapid development and approval of an effective vaccine for the influenza A H1N1 virus.
Novartis (Basel, Switzerland) this week announced it had produced the first batch of influenza A (H1N1) vaccine. The manufacture of 10 L of wild-type vaccine monobulk, to be used for preclinical evaluation and testing, was completed in the Marburg, Germany, facility using cell-based, rather than egg-based, methods.
The company says it expects to achieve rapid scale-up of the vaccine manufacture with the reassortant seed provided by the US Centers for Disease Control (CDC) at the end of May. Novartis also plans to start clinical trials in July and says it expect licensure in the fall of this year.
According to a company press release, more than 30 governments have requested egg-based and cell-based vaccine ingredients from Novartis. In May, the US Department of Health and Human Services placed a $289-million order for the company’s ingredients, including its proprietary adjuvant “MF59.”
GSK (London) says that in addition to increasing production and supply of it antiviral Relenza (zanamivir), the company continues to work toward developing an aduvanted vaccine candidate at its Canadian and German sites. The company also received a seed strain from WHO and, according to a company statement, “the first doses of the A (H1N1) vaccine antigen are expected to be available in four to six months, subject to regulatory approval.”
In Beijing, China, vaccine maker Sinovac Biotech has begun the production of its vaccine against influenza A (H1N1). The company received a virus seed from CDC earlier this month. Sinovac claims its current annual manufacturing capacity is approximately 20-30 million doses of pandemic influenza vaccine.
Meanwhile, the European Medicines Agency (London) launched its pandemic crisis-management plan to facilitate the rapid assessment of vaccines and antivirals, their availability, and their safe use during a pandemic. EMEA is working with vaccine manufacturers and industry regulators to clarify the necessary requirements for clinical and nonclinical data that would be necessary to support the authorization of influenza A (H1N1) vaccines and the strain that would be recommended for vaccine manufacture.
The European Union has approved four mock-up influenza-pandemic vaccines. As part of the management plan, EMEA is working toward identifying the required data that would allow for the modification of the marketing authorization that would replace the current mock-up virus with one of the A (H1N1)-derived pandemic-like strains recommended by WHO. According to EMEA, the agency is “of the opinion that companies using the mock-up approach would have to provide significantly less data, as important issues such as effectiveness and safety of adjuvants or dosing schedules in defined populations were already established at the time of the authorization.”
See related PharmTech articles:
WHO, GSK Provide Update on Pandemic Flu Production (ePT newsletter)
Continued Steps toward H1N1 Vaccine (blog post)
HHS Order H1N1 Vaccines and Vaccine Antigen (ePT newsletter)
Swine Flu Update (ePT newsletter)
Vaccines Progress Along the Critical Path (blog post)
How to Make a Swine Flu Vaccine (online exclusive Q&A article)
Process Considerations for Cell-Based Influenza Vaccines (April 2006 issue article)