The new facility is 10 times larger than >MedImmune's existing manufacturing facility in Speke, and will allow the company to produce up to 15 million doses per month, or about 90 million doses per influenza manufacturing season, of its trivalent, intranasal flu vaccine, FluMist.
This is a mammoth increase in vaccine production considering the company only produced 3 million doses of FluMist this year and the decision to ramp up production may seem somewhat ambitious.
Launched in 2003, FluMist was the first nasal spray vaccine to gain US approval and it was expected to be a blockbuster drug, however, it has so far had a poor performance in the market.
In the first year of launch only 450,000 of the 4-5 million manufactured doses of FluMist were sold during the winter of 2003-2004.
Again this season only one third of the three million doses have so far been sold even though there is currently a flu vaccine shortage in the US. Some analysts are attributing the disappointing sales to poor marketing of the product.
Delivered as a nasal mist, FluMist is a live virus vaccine that uses a modified attenuated (weakened) form of the influenza virus to stimulate a protective immune response in the body.
MedImmune is one of four manufacturers distributing flu vaccine this year, alongside Sanofi Pasteur, Chiron and GlaxoSmithKline however Medimmune lags well behind the others in terms of production volume and sales.
However, with the latest plant expansion, the company appears to be making a considerable effort to increase its presence in the market and become more competitive.
"The approval of our new manufacturing facility demonstrates MedImmune's ongoing commitment to being a worldwide leader in the influenza vaccine market," said Bernardus Machielse, senior vice president, operations.
And there is plenty of incentive to do so. It is predicted that the global vaccine market could quadruple in size by 2015 to £17-£24 bn from its current level of around £5 billion (€7.4bn).
In particular, global demand of flu vaccine currently grossly exceeds supply and demand is expected to increase dramatically, stemming from worldwide stockpiling of the vaccine amid fears of an imminent bird flu pandemic, and shortages in production due to problems with the manufacturing plant of top supplier, Chiron.
"With this facility, we can substantially ramp up production. The facility could also be used to produce vaccine year round in the event of an influenza pandemic," Machielse said.
The company is also now working with the National Institutes of Health to produce and test attenuated, live intranasal flu vaccines against pandemic influenza strains, using MedImmune's proprietary reverse genetics technology, which allows researchers to remove potentially pathogenic portions of a pandemic virus and make the vaccine and its production safer.
Furthermore, in addition to increasing the capacity for FluMist production, the company also plans to use the new facility to make its novel influenza vaccine, known as CAIV-T (cold adapted influenza vaccine, trivalent) once it receives marketing approval.
Preliminary data from a Phase III study has shown that CAIV-T reduced an influenza illness caused by any influenza strain by 55 per cent compared to the injectable influenza vaccine (TIV).
Unlike the FluMist, CAIV-T does not have to be frozen, making it easier for the medical community to store and administer and MedImmune expects to have it on the market within two years.