Last week Fierce Vaccines posted an article on the top selling flu vaccines of 2012. Novartis’ Optiflu™ was number seven on the list with sales steadily increasing since approval by the European Union in 2007. Worldwide sales in 2009 were at $17 million, 2010 at $27 million, 2011 at $36 million and estimates for 2012 are at $71 million. While use has been increasing worldwide, OptiFlu™ is still not approved for use in the United States.
The U.S. Department of Health and Human Services (USHHS) has been supportive of cell culture based vaccine technology and Novartis has been a leader in this area. In 2005-2006, the USHHS awarded contracts to five companies to improve current vaccine technology and build cell culture based vaccine facilities. Of five companies that received those contracts only one so far, Novartis, has opened a U.S. cell culture vaccine manufacturing facility. The Novartis facility in Holly Springs, North Carolina received Federal approval for the production of influenza vaccines in December 2011. While the one billion dollar facility was the first of its kind in the United States, there are several European facilities approved for cell culture-based vaccine manufacturing.
There are many advantages to using a cell culture-based manufacturing system for vaccines. One of the key advantages is that cell-based manufacturing reduces long lead times required with egg-based production. Egg-based production requires pre-order of eggs in which to manufacture the virus, which limits the ability to scale up quickly. Conversely, cell culture can be scaled up quickly as needed. Cell culture based manufacturing also allows for culture of avian flu virus, which cannot be done in eggs without modifications. Cell based production is important in the case of a pandemic because vaccines can be manufactured more quickly and in larger amounts. USHHS officials recognize these advantages and have stated that the Novartis Holly Springs facility could produce up to 25% of the country’s vaccines in the event of a pandemic.
In addition to manufacturing benefits, clinical trials have proven that cell culture-based vaccines are just as safe and efficacious as their egg-based counterparts. According to a study published in 2010 in Clinical Infectious Diseases, titled “Clinical Efficacy of Cell Culture—Derived and Egg-Derived Inactivated Subunit Influenza Vaccines in Healthy Adults,” OptiFlu™ was just as effective as traditional egg based flu vaccine. The study conducted over the 2007-2008 flu season compared efficacy of OptiFlu™ (manufactured using MDCK cells), Agrippal™ (egg-derived trivalent inactivated vaccine) and placebo in 11,400 healthy adults under 50 years of age from the U.S., Finland and Poland. Compared to placebo, OptiFlu™ was 84% effective against the flu strains contained in the vaccine and Agrippal™ was 78% effective. In both vaccines the side effects were similar.
Cell culture-based flu vaccine manufacturing is faster, more flexible and just as safe and effective as traditional egg-based manufacturing. So it seems that OptiFlu™ and products like it will continue to increased yearly sales, particularly if approval is granted in the U.S.