How can doctors help protect the elderly from influenza? It is a quiet problem, happening one patient at a time—-flaring in winter, to be sure—-but lacking the drama of a pandemic. Year after year, older people die of influenza when, researchers believe, those deaths often are premature and preventable.

According to a new study to be published in the July 15, 2009, issue of  the Journal of Infectious Diseases, there may be a better way to use flu shots on the front end to improve the older person’s resistance. Up the dose for them.

1. They have to get their flu shots. For decades, older people were resistant to the idea but use rates have risen among older adults in recent years.

2. The shots have to work. These shots are not working in the same way they do for younger people, according to the data. In fact, despite higher vaccination rates among older people, hospitalizations and deaths from seasonal influenza among these patients are going up.

3. One possible solution proposed is the use of a higher dose (HD) influenza vaccine, a dose two or three times stronger than that given to younger people.

In an industry-supported, double-blind, phase III study conducted at 30 centers in the U.S. of 3, 876 participants,  the teams gave twice as many patients the HD vaccine instead of the standard dose (SD). The purpose was to see if the antibodies to the viruses in HD patients were any greater than those getting the same dose as everyone else (SD).

The good news: The antibodies were significantly higher. The take-away, then, is that the HD ought to help older people stay out of hospitals and reduce the death rates, which are much higher in this patient population. (Ed Note: A randomized, double-blind, multi-center study findings is the gold standard for studies such of this kind.)

4. If HD vaccines were provided,the real test of them would be in the real world response. How many elderly people hospitalized or die from influenza? There always are “confounding factors,” things doctors cannot control or, sometimes, foresee. An example would be an sudden mutation in the virus, one no vaccine included because of production time needed to make and deliver enough shots to doctors.

Another related question. The so-called “seasonal” flu, the kind that comes in winter, is continuing to affect patients well into summer and with no signs of weakening. Assume this HD vaccine were available today. The CDC weekly update reports both confirmed cases of “seasonal” flu and the pandemic flu strain together. On a world-wide scale, it is not possible to distinguish between seasonal and the novel H1N1 pandemic strains as long the seasonal nor the pandemic strains continue to cause mild illness, for the most part.

The editors of this journal say that the time has come to license and use the HD influenza vaccine. The time needed to develop a vaccine usually takes years. Perhaps, in this case, it would not take so long. The study looked at increasing the dosage to triple or quadruple strength, not inventing a new one.

Still, the process of approvals and licensing always takes time—-also as in years. Perhaps, given the hazards to older people and the comparative costs of vaccination versus hospitalization, the FDA can move more quickly.

The study showed that, while the participants had more localized response to the higher dose, such as more redness around the injection site were mild to moderate. There effectiveness of the vaccine was the same, regardless of responses at the time of the injections.

Journal Watch/Infectious Disease

“Despite increasing vaccination rates among older adults in recent years, the rates of hospitalization and death from seasonal influenza have risen. Reduced influenza vaccine efficacy in this population translates to less-than-optimal protection. One possible solution to the problem would be use of a higher-dose vaccine.” (JW Gen Med Jun 16 2006).

“A total of 3876 participants were randomized in a 2:1 ratio to receive HD or SD vaccine. Serum samples, obtained at baseline and at 28 days postvaccination, were assessed for antibodies to each of the three vaccine components by hemagglutinin inhibition (HAI) testing.

“Prevaccination HAI titers for the three virus strains were similar between the HD and SD vaccine groups. At 28 days postvaccination, a significantly greater proportion of HD vaccine recipients than of SD vaccine recipients had achieved seroprotective HAI titers (i.e., titers 1:40) for all three virus strains. A significantly higher proportion of HD vaccine recipients than of SD vaccine recipients had HAI titers 1:80 and 1:160. Local vaccine reactions — typically mild to moderate — were more common in the HD vaccine cohort; the rate of systemic reactions was similar between groups.

The editors comment:

…”The time has come for licensing and using HD influenza vaccines designed for older individuals. As highlighted in an accompanying editorial, scientists, vaccine manufacturers, policy makers, and healthcare providers should be encouraged in their efforts to achieve this goal. Enhanced protection against influenza is an important step toward improving health in our aging population.”

Source: Journal Watch/Infectious Disease, June 16, 2009

Citation: Journal of Infectious Disease, 2009 Jul 15; 200:172. (Print publication date July 15, 2009).