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Is the newly FDA approved influenza vaccine the game-changer we need?

photo: USACE Europe District via flickr

Last month, Justin Paquette wrote about a U of M-led analysis, which found an urgent need for new, game-changing influenza vaccines.

According to the report by University of Minnesota’s Center for Infectious Disease Research and Policy (CIDRAP), the current influenza vaccines offer less protection against seasonal influenza than previously reported.

Fast-forward to today. According to the Wall Street Journal, the Food and Drug Administration (FDA) has approved the first seasonal influenza vaccine produced without the use of fertilized chicken eggs.

Is this the game-changing vaccine CIDRAP researchers are calling for?

I met up with Nicholas Kelley, Ph.D., preparedness program coordinator at CIDRAP and co-author of the center’s recent report.

He had this to say:

This vaccine was licensed in the Europe in 2007, and is only now approved in the U.S. today. A mammalian-cell-culture–based inactivated influenza vaccine is an incremental – not a game-changing – advancement for influenza vaccines.

 The use of mammalian-cell culture to produce influenza vaccines is a change in manufacturing technology, not a change in the way the vaccine protects the recipient from developing influenza infection.

 In short, cell culture manufacturing technology uses the same antigen as traditional egg-based inactivated influenza vaccines; therefore, a similar level of vaccine effectiveness is expected as with our current licensed inactivated influenza vaccines*.

So, if not a more effective vaccine, why was this vaccine licensed?

In theory, this kind of manufacturing technology can improve the speed in which the first dose of a vaccine is available by a few weeks and boost the total number of doses produced.

However, during the 2009 influenza pandemic, mammalian-cell-culture–based vaccines were used in Europe and much like in the U.S., the vaccine arrived too little, too late to have a significant public health impact.

What can we learn from this recent licensure?

Since 2005, the U.S. government has invested more than $1.7 billion in domestic cell-culture–based influenza vaccine production. The licensure of this vaccine serves as a reminder of the time and investment necessary for an incremental change to occur.

It is also a reminder of how difficult it will be to bring a game-changing influenza vaccine to market without significant changes to the influenza vaccine enterprise.

It appears that this new vaccine is not the game-changing vaccine we need, however, it is a  small step  in the right direction. Hopefully, the next time large quantities of flu vaccines are needed; this technology will step up to the challenge.

*Author’s note: This point was noted in the final report of the CIDRAP Comprehensive Influenza Vaccine Initiative (CCIVI). 


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