PRODUCTION of the new Pandemic (H1N1) 2009 vaccine is in full swing. With clinical trials completed or on the verge of completion, most manufacturers are waiting for the green light from authorities before the vaccines are shipped out.
With the expected high demand for the vaccine, production has to be ramped up to ensure there is enough to meet global demand. The World Health Organisation (WHO) had earlier identified 24 countries with facilities to produce the vaccine and provided them with the seed virus – weakened form of the virus that will be used in the vaccine.
Malaysia has placed an order of 400,000 doses with pharmaceutical giant GlaxoSmithKline (GSK) and will be obtaining an initial 40,000 doses in October, with the remainder in January next year.
According to Francis Del-Val, vice-president and managing director of GlaxoSmithKline Pharmaceutical Sdn Bhd, the company has more than 10 years of investment in research and development of pandemic influenza vaccines.
“GSK is making rapid progress to produce the vaccine. We are investing heavily in increasing our capacity to help governments and other organisations to respond to a global influenza pandemic,” he says.
Similarly, Sanofi Pasteur (SP) has been well prepared for any pandemic situation. SP, a member of the Sanofi-Aventis Group, is the largest producer of seasonal influenza vaccines in the world, producing 40% of global supply.
“Our organisation has specific plans in place to ensure we can continue production of our vaccines and begin full-scale pandemic influenza vaccine production when directed,” says Sanofi Pasteur medical manager Dr Shree Jacob.
But they do not yet know for sure how many doses can be produced as there are factors yet to be determined, such as the actual effective dosage required.
“We will be able to answer this question better once we have experience with it in a production environment and once clinical studies have been conducted.
“We estimate our contribution will be in line with our current capacity for seasonal vaccine,” she adds.
Says Del-Val: “Volume capacity will depend on various factors such as the manufacturing yield that can be achieved from the strain and the production time required. The manufacturing process for this strain will be stringently evaluated and improved where possible. The total capacity will be determined as a result of these ongoing efforts.”
Both GSK and SP began large-scale production of the vaccine in June, with clinical trial results expected by October for SP while GSK received the results from its first clinical trial on Sept 14 (from Germany). SP’s trial involved 6,000 volunteers and GSKs 9,000.
While production of the H1N1 vaccine is ongoing, the seasonal vaccine is not being set aside.
“Production of seasonal influenza vaccine for both northern and southern hemispheres is still a priority as seasonal influenza is a very serious illness causing an estimated 250,000 to 500,000 deaths per year. The decision to prioritise southern hemisphere seasonal influenza vaccine production over H1N1 should be taken by WHO and the authorities in due time,” says Dr Jacob, adding that the recommendation for southern hemisphere influenza vaccine strains is usually decided by WHO in September.
More importantly, both companies will ensure that their vaccines will be accessible to the poorer countries.
“Once production of the A(H1N1) vaccine begins, SP will reserve 10% of its output as a donation to WHO to help address the threat of a pandemic in developing countries. In the event that Sanofi Pasteur’s manufacturing facilities become fully committed to the production of pandemic vaccine, we will supply this vaccine under a tiered-pricing policy for developing countries,” says Dr Jacob.
GSK is adopting similar steps.
“To ensure that the vaccine is available to developing nations, the company has allocated 20% of production at its Canadian manufacturing site to developing countries. Included within this capacity is GSK’s proposed donation of 50 million doses of the H1N1 vaccine to WHO,” says Del-Val.
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