FLUAD, The Next Generation Vaccine?

One thing you can count on seeing every winter is a flu outbreak. Influenza is a viral respiratory illness that has been the cause of worldwide epidemics (“pandemics”). In 1918, the Spanish Flu spread throughout the globe and killed close to 100 million people.

 
Even non-pandemic influenza can turn deadly in some cases. The Centers for Disease Control and Prevention have limited information on official death counts from flu each year, but it can be anywhere from a few thousand to fifty thousand in the U. S., mostly among those over 65.

So many people get the flu yearly (one in five to one in twenty in recent years) that modern medicine has worked diligently to try and prevent it. This has led to the development of vaccines. Vaccines work by exposing you to the previous year’s virus in the hope that you will develop immunity to this year’s version. Now, the Food and Drug Administration has approved a new type of flu vaccine with a “booster” meant to improve the immune system, especially in the elderly. This new vaccine, called Fluad, claims to translate into better outcomes among older people.

Fluad’s main target is people over 65 years of age. The elderly typically do worst if they get the flu, so much so that influenza has been called the “Old Man’s Friend” because it ends their suffering, and I mean permanently. According to an FDA spokesperson: “Immunizing individuals in this age group is especially important because they bear the greatest burden of severe influenza disease and account for the majority of influenza-related hospitalizations and deaths…”

Fluad contains MF59, a mixture that includes squalene, an oily nutrient produced by the liver but also seen in sharks, certain birds, and amaranth seeds (it also includes some preservatives). When incorporated into vaccines, MF59 increases the number of immune cells that are activated.

From a pandemic standpoint, there’s another benefit: Adding MF59 can help extend vaccine supplies. People might need a lower dose of vaccine, thus allowing more to receive it.

The government actually considered using MF59 when the Swine Flu arrived in the U.S. in 2009. But, although vaccine supplies were short, MF59 wasn’t used due to the expected resistance to the new ingredient.

U.S. government officials have been wary about using MF59 in vaccines because of public suspicion of new ingredients in medical treatments in the U.S. Fluad, however, has been in use in Europe and Canada for close to 20 years; the FDA now declares it to be safe and effective.

Vaccine effectiveness is a big issue, because last year’s vaccine was only around 20% effective in preventing the flu in those who took it. Normally, you want a flu vaccine to be 60% effective or more.

There are two reasons why last year’s vaccine failed, relatively speaking. The formulation may not be effective against a particular virus if the virus mutates or a new virus arrives. Also, if the vaccine doesn’t activate a person’s immune response, it won’t work to produce antibodies against the virus.

Tests show Fluad works at least as well as the vaccines already on the market, and may boost a senior’s protection from H3N2, one of the currently circulating strains of influenza.

(DID YOU KNOW: Type A (the most common) Influenza viruses are categorized by certain proteins on their surface called HA (Hemaglutinins) and NA (Neuraminidases). For example, Swine Flu is H1 N1.)

The CDC recommends that everyone over 6 months of age receive the vaccine. Despite this, only 148 million doses get distributed in the United States, a country with a population of more than 300 million. This is because of concerns on the part of many of adverse reactions. Some believe that reluctance is also due partly to the injection required, so a nasal mist was developed. Unfortunately, shortages are commonly reported.

Another concern is the possibility of  an adverse reaction to something in the vaccine. Ill effects of flu vaccine can be minor or major. Minor problems following a flu shot include pain, redness, and swelling at the site of injection, plus flu-like symptoms. If these occur, they usually last 1 or 2 days.

This doesn’t mean, however, that serious problems can’t occur with vaccines. One in a hundred thousand to a million people may develop a disorder called Guillain-Barre syndrome, which can cause long-term damage to nerves. Children may, rarely, experience seizures due to high fever from a flu shot. Of course, anyone could be allergic to a component of the vaccine, causing a mild to serious reaction. Major reactions seems to occur in one in a million cases.

You won’t find Fluad on pharmacy shelves this year but it should be available next year. Will it decrease flu-related deaths among older citizens in the U.S.? We’ll have to wait until 2016 to find out.

Joe Alton, MD

To find out more about influenza, check out our classic 4 part series of articles, or get a copy of our bestseller The Survival Medicine Handbook, with over 250 5-star reviews.

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