Which Flu Shot Should One Receive?

The air is thick with rumors about the swine flu vaccination in Budapest. Some are partially grounded in fact (doctors may be held legally liable for infecting patients if they do not immunize themselves), others are ridiculous (conspiracy theory about injecting computer chips for surveillance along with the vaccination). Even among physicians there is a lot of contradictory advice.

With the wealth of misinformation circulating, it is no wonder the level of doubt and panic is at an all-time high.

To allay fears and misgivings, the pediatricians at Rozsakert Medical Center have compiled a list of the most frequently asked questions regarding the H1N1 epidemic.

What kinds of flu shots are available in Hungary?

The 2009 version of the plain old seasonal flu shot (Rozsakert carries GlaxoSmithKline’s Fluarix brand), is immediately available to all over 6 months of age. This protects against the regular influenza, which circulates from about December to March. It is safe, effective and extensively tested. However, this vaccine does NOT protect against the H1N1 new influenza, otherwise known as swine flu. It is recommended that this vaccine be given in addition to the swine flu vaccine.

The H1N1 (”swine flu”) vaccine produced by a Hungarian pharmaceutical, called FLUVAL P, is a whole cell vaccine, specifically made to prevent the H1N1 virus from taking its toll. This is the only brand that is available in Hungary. It is a new vaccine, as the disease is also new.

Which flu shot should one receive?
Both!

Can one receive both vaccines at the same visit?
There are data supporting the simultaneous injection of the Hungarian brand Fluval P with Hungarian brand Fluval AB (seasonal influenza) in adults. The American Academy of Pediatrics and the Center for Disease Control in Atlanta, Georgia, also recommend giving the seasonal flu shot at the same time as the split virus swine flu preparation available in the States. There is no data concerning mixing of brands, or of simultaneous injection with the Hungarian Fluval P for children under 18 years of age .
In order to better survey the possible side effects of the vaccines, we, the pediatricians at Rozsakert Medical Center, are recommending the Fluval P be injected first, followed in 2 weeks by the seasonal flu shot.

How many shots are necessary?
The Fluval P is indicated for a one-time injection.
The split virus Fluarix is to be given twice, a month apart, if the recipient is under 9 years of age and has never had the seasonal flu shot before. If the child has had the vaccine in years past, only one is needed. Adults need be injected only once.

Is the dosing different for adults and children?
According to the package insert, the dose of Fluval P is 0.25 ml for those under 13 years of age. Older patients receive 0.5 ml intramuscularly.

May children receive the vaccines?
Fluval P has not been tested in those younger than one year of age. There was a very small study (ten participants) of children aged one year to three years of age that collected side effect, but not efficacy data. In other words, Fluval P is probably safe and effective in the infant population but there are no studies to support this.

Fluarix (and other split virus seasonal vaccines) have been extensively studied and used in children as young as half a year, and are deemed safe and effective.

May pregnant women receive the vaccine?
Fluval P is not only indicated, but highly recommended for pregnant women.

What about Fluval P side effects?
Based on a pre-marketing study of over 600 people, soreness at the injection site was frequent, fatigue and low grade fever were occasional. These symptoms were short-lived (1-2 days). No severe reactions were noted.

Can you catch the flu from the shot?
No! Both Fluval P and Fluarix are inactivated (dead) virus vaccines, so it is impossible to contract the disease from the vaccine.

Who should not receive the Fluval P swine flu shot?
People allergic to gentamycin, formaldehyde, neomycin, vancomycin and ciprofloxacin should not get the vaccine. Those who have serious egg allergies should also avoid Fluval P and Fluarix. A current illness with fever is a contraindication, but a mild runny nose is not.

What is the worst case scenario if one receives the swine flu shot?
In 1976 a different swine flu vaccination was temporally associated with an increase in Guillain-Barre syndrome. One in a 100,000 recipients suffered from this disease, which causes reversible ascending paralysis and is rarely fatal. Of note is that during epidemics, the incidence of Guillain-Barre is more common among people who have NOT received the vaccine as well. There have been NO cases of Guillain-Barre syndrome associated with this epidemic, this is just a theoretical possibility.

What is the worst case scenario if one does NOT receive the flu shot?
There is a less than 1% case fatality rate from influenza disease. Specifically, as of November 2009, the overall mortality rate from H1N1 in the USA is 0.4%, and 0.1% for the seasonal flu this year. Even though death is a very unlikely outcome from the disease, it is even more unlikely that one would die of a vaccine side effect.

What about the mercury issue?
Fluval P contains thiomersal, a mercury based preservative. Although heavy metals like mercury can be toxic, thiomersal has been used in vaccines for decades and has never been proven to cause any untoward side effects. In recent years, thiomersal has been removed from almost all childhood immunizations, so today’s youngsters are exposed to much less mercury via vaccination. We do not feel the presence of thiomersal in this one-time vaccine poses a significant risk.

In summary, weighing the risks and benefits of immunization, we recommend universal vaccination for all those over three years of age, and consultation with a pediatrician regarding vaccinating those under three.

Because vaccine distribution has already been an issue, with just a trickle of a supply of Fluval P, it is suggested that parents sign up for free vaccination at schools and work-places, and also call their physician to be put on a waiting list at private clinics like Rozsakert Medical Center. A third option is to request a prescription for Fluval P, and do the rounds at neighborhood pharmacies on your own. Since it is difficult to predict whether the private or public sector will be supplied first, it would behoove one to cover all bases. We at Rozsakert would be more than happy to administer vaccines brought from other sources.

Non-urgent questions, prescription and waiting list requests may be sent to me at jokay@medical-center.hu.
I am also available for urgent consultation at 30 820 1451.

I hope the above information has lifted the fog from the swine flu pandemonium!

Kinga Jokay, M.D.
Fellow of the American Academy of Pediatrics
Rozsakert Medical Center