H1N1 Vaccine Production and Update

USA Today’s headlines on Sunday, October 25 read: “Obama: Swine Flu a National Emergency”, bringing even more attention to a topic that has taken over media outlets for the past couple months. Whether the “Emergency” declaration is overkill or not is a political debate, but the vaccine shortage that has contributed to it affects GSK directly since they are a producer of the H1N1 vaccine. The government initially estimated that as many as 120 million vaccine doses would be available by mid-October, an optimistic prediction that has been met with a deliverance of only 11 million.

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The production of a vaccine is a complicated process, both scientifically and due to regulatory restrictions. The process begins with the World Health Organization (WHO), who must identify the virus and provide production companies such as GSK with a ‘seed strain’. The ‘seed strain’ is a version of the virus that has been adapted so it no longer causes the disease, and is the starting point of production. GSK then develops its own ‘seed bank’ to draw from that is an optimized version of  the ‘seed strain’. There are several ways to proceed from here, GSK has reported that it will go the traditional route and use fertilized chicken eggs to produce the vaccine. Eleven days after the eggs are fertilized, the ‘seed bank’ virus is injected, incubated and harvested over the period of several days. After harvesting the virus is purified and broken down to separate out the antigen, the part used in the vaccine. It is then vialed, labeled, and ready for quality testing (source).

Between one and two eggs are needed to produce one dose of vaccine and the entire production process lasts about six months (source).

A visual summary of the vaccine production process can be viewed HERE.

GSK began production of the H1N1 vaccine in June after receiving the seed strain from the WHO. It is currently being manufactured at specific sites in Canada and Germany (source).

Although egg-based vaccine production (which GSK is using) is a tried and true method that has the double benefit of being cost effective. There are disadvantages, however, that have been magnified due to the demand this flu season. The extensive logistical planning required to produce the vaccine (think millions of eggs) could be a huge impedance on production with an exponentially increasing demand. Not only would GSK have to procure mass amounts of eggs, but also safely store them and validate them for use.  The inflexibility of supply caused by the egg production method has been strikingly apparent this flu season with the skyrocketing demand. Other risks to using the current production system include potential impurities in the eggs as well as patient allergy to egg albumin. The detection of impurities in one dose of the vaccine could void an entire batch, creating a substantial loss for the company(source).

An alternative, and less common, way to produce the vaccine would be to do so using cell or tissue cultures. This method is fairly new but all major companies in the vaccine industry have been involved in its development. The concept for the production process would be fairly similar to that using eggs: inject, incubate, harvest, purify,separate, and vial. The difference is that mammalian kidney cells would be used as the host instead of a fertilized egg.One major advantage culture based systems have over egg based systems  is the ability to rapidly scale production. However,  the cost of production equipment is much higher and the yield time may be slightly slower (source).

The video below shows an animation of culture cell production created by one of GSK’s competitors, Novartis.

The question of if and when GSK will shift vaccine production from egg based to culture based is one that will ultimately be answered by financial means. In lamens terms, the benefits will have to trump the costs. Although the statement is simple, the factors involved in validating it are incredibly complex. Analysts at GSK will first need to determine the amount of capital they are willing to invest in developing the project. These investments will include things like the purchase of specialized  equipment, research funding, and availability of inputs. They also must consider the opportunity costs of development such as dedication of production space and personnel resources at a time where the flu vaccine is in such heavy demand and these resources could be utilized in other parts of the company.

The short term investments GSK will have to make are important factors to consider, but equally so is the long term forecast for vaccine demand. For example, having an operating culture based production system at present would have given GSK a huge advantage over the competition. They would have been able to re-allocate resources toward production of the H1N1 vaccine much more quickly and therefore increased profits. The question is, will having a more scalable production system create a great enough future benefit to cover the up-front costs? This question has no concrete or verifiable answer, and must be based on current information and prediction of future trends. It would be a gamble, one that could either pay off big or create a substantial loss for the company.

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