Officials with Protein Sciences Corporation announced this week that the US Food and Drug Administration has approved the 2016/17  formulation of Flublok®  influenza vaccine. 

In a post-marketing clinical study of 9,000 adults 50 years and older during the 2014/15 flu season where H3N2 influenza was dominant, people who received Flublok were 40% less likely to get cell culture confirmed influenza than people who received an egg-based influenza vaccine. FDA approval of the 2016/17 formulation of Flublok means that Flublok is on track to ship to healthcare providers in early August, according to a prepared statement from the company.1

Just weeks ago, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) recommended against using the FluMist® Quadrivalent Live Attenuated Influenza Vaccine in the US for the 2016-2017 influenza season after reviewing some effectiveness data, which AstraZeneca officials said contrasted with data seen in other countries. 


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In a statement released to the media after that recommendation, officials with the Centers for Disease Control and Prevention noted: “The ACIP vote could have implications for vaccine providers who have already placed vaccine orders. The ACIP recommendation may particularly affect pediatricians and other vaccine providers for children since data from recent seasons suggests nasal spray flu vaccine accounts for about one-third of all flu vaccines given to children.  CDC will be working with manufacturers throughout the summer to ensure there is enough vaccine supply to meet the demand.” 

Reference

1. Protein Sciences Corp.  2016/17 Formulation of Flublok® Influenza Vaccine Receives FDA Approval. 2016; Press release, package insert.