Flu seasons are unpredictable and can be severe. Over a period of 30 years, between 1976 and 2006, estimates of flu-associated deaths range from a low of about 3,000 to a high of about 49,000 people. Today, pharma giant Baxter’s Preflucel has demonstrated a new ability to protect against this potentially life threatening ailment.

During 2009-2010, a new and very different flu virus (called 2009 H1N1) spread worldwide causing the first flu pandemic in more than 40 years. It is estimated that the 2009 H1N1 pandemic resulted in more than 12,000 flu-related deaths in the U.S. In contrast to seasonal flu, nearly 90% of the deaths occurred among people younger than 65 years of age.

Complications of flu can include bacterial pneumonia, ear infections, sinus infections, dehydration, and worsening of chronic medical conditions, such as congestive heart failure, asthma, or diabetes.

The study data show nearly 80% protective efficacy against the influenza strains contained in the vaccine and a low adverse event profile. Preflucel is manufactured using Vero cell technology, offering an innovative method of vaccine production compared to conventional embryonated chicken egg production, which has been used for decades.

Vero cell technology uses the natural virus, identical in protein composition to the virus circulating in nature, instead of genetically modified virus strains that are widely used for egg-based vaccine production. The resulting vaccine is of high purity because it is free of preservatives, antibiotics and egg proteins, and is suitable for adult and elderly populations, as well as people with egg or antibiotic allergies.

Professor John Oxford, D.Sc., Barts and The London School of Medicine and Dentistry, Queen Mary, University of London states:

“Seasonal influenza claims thousands of lives every year, but can be very effectively prevented through wide-spread vaccination. This study provides important new information that Baxter’s Vero cell-derived seasonal vaccine is well-tolerated, immunogenic and efficacious and should be considered when planning public health preventive efforts around flu season.”

Study results indicated that participants responded positively to the vaccine, with 78.5% protective efficacy against culture-confirmed influenza infection (CCII) and robust immune responses (measured as seroprotection rates) against the three viral strains contained in the vaccine: A/H1N1- (88.0%), A/H3N2- (93.3%) and B-specific (97.1%).

In addition to protection, study investigators found significantly reduced duration and severity of influenza symptoms in infected subjects in the vaccinated group, as compared with the placebo group in a subsequent analysis. The vaccine was well tolerated, with no treatment-related serious adverse events reported during the trial.

Hartmut Ehrlich, M.D., vice president of global research and development for Baxter’s BioScience business, and senior author of the new study continues:

“Preflucel has demonstrated robust immunogenicity and protective efficacy against common circulating flu strains, and may provide an important alternative to egg-based vaccines in planning seasonal influenza prevention efforts with a shorter production timeline. The positive developments in vaccine cell-culture technologies may help contribute to improved strain selection and more robust vaccine supplies for the growing preventive health efforts around the world.”

Preflucel is available in Austria and Czech Republic for the 2010 to 2011 influenza season. Baxter expects to receive approval of Preflucel in additional countries in Europe in 2011.

On February 24, 2010 vaccine experts voted that everyone 6 months and older should get a flu vaccine each year starting with the 2010-2011 influenza season. CDC’s Advisory Committee on Immunization Practices (ACIP) voted for “universal” flu vaccination in the U.S. to expand protection against the flu to more people.

While everyone should get a flu vaccine each flu season, it’s especially important that certain people get vaccinated either because they are at high risk of having serious flu-related complications or because they live with or care for people at high risk for developing flu-related complications.

Source: Baxter International

Written by Sy Kraft, B.A.