For Sanofi Pasteur the preliminary results from a 2-year clinical study involving 126 centers and some 32,000 seniors just presented to the Advisory Committee on Immunization Practices (ACIP) were just what the doctor ordered.
Data showed their new “high-dose” FLUZONE (H-D) flu vaccine formulated specifically for use in seniors did exactly what was intended—boosting the efficacy of that formula for preventing confirmed flu cases by 24.2% compared to the standard dose vaccine used previously.
Older patients suffer more flu illnesses, hospitalization, and deaths compared to younger folks, even if vaccinated, in part because the efficiency of their immune systems declines with age and they don’t respond as well to regular dose flu vaccine. Consequently, an elderly person’s antibody response to the regular vaccine was variable and usually less than that of children and younger adults.
Sanofi’s high-dose formula with 4X the amount of viral antigenic material was designed to “turbo-charge” their immune systems’ responses and produce greater quantities of antibodies thus protecting them more effectively against flu infections…and this study shows convincingly it did just that.
The study was done over two flu seasons—the milder-than-usual 2011-2012 and the much more severe than average 2012-2013 seasons. Moreover, the good results held for each flu season and across both seasons, all flu strains, and all senior age sub-groups. Early results also showed the H-D version provided better protection against pneumonia, hospitalization, and cardiorespiratory conditions. The H-D variety did cause slightly more local reactions at the injection site but overall side effects were similar with the two formulations and there were no indications of serious adverse events.
The Sanofi M.D. presenting the results said using the new H-D product would prevent four to five more flu cases for every 1,000 people vaccinated with the FLUZONE than would be prevented with the regular dose version. [Another way of seeing the difference between the two formulations is that for every 217 people receiving the FLUZONE High-Dose variety, one more flu case gets prevented.]
Doctors on the Advisory Committee who saw all the data alluded to the fact that this new high-dose vaccine could be a “game-changer” in that the previous one-size-fits-all approach needs to be re-examined. Lisa Jackson, MD, MPH, who is a flu vaccine researcher but not an ACIP member said: “This (these new findings with H-D) raises the question of whether everyone could benefit from a higher dose (of vaccine, regardless of age or immune status).” Lots of people at “high-risk’ from flu also have compromised immune systems of varying degrees. If the elderly responded so much better to the H-D formula, perhaps others will also.
Dr. Jackson added: “I don’t know if ACIP will make a preferential recommendation for high-dose flu vaccine, but they should, in my opinion.”
A better flu vaccine this year for seniors who were a group hit hardest by flu last year…well, that really is great news and “just what the doctor ordered” because “Every life matters…every shot counts!”