FDA: Fluzone Vaccine Safety

 

 

 

# 5247

 

For all the good they do (which is considerable), influenza vaccines are not perfect. They are drugs that can, and sometimes do, produce undesired side effects. 

 

Most of the time, these adverse reactions are relatively minor; injection site soreness, mild fever, or a day’s malaise. 

 

While it rarely happens, more serious side effects can occur.

 

Which is why the CDC and the FDA monitor adverse incident reports surrounding the receipt of vaccines via several methods, including the VAERS reporting system.

 

Recently the VAERS system has indicated a small – but higher than expected - number of febrile convulsions in children under the age of 2 years, who had recently received Sanofi’s Fluzone Vaccine.

 

According to a Reuters Report yesterday, 42 instances of febrile convulsions had been reported by mid-December, occurring shortly after receipt of the Fluzone vaccine.  Of those 38 happened within 24 hours.

 

In all cases, these children recovered and apparently suffered no long-term effects. 

 

Febrile convulsions are, of course, very common in children under the age of 2.  In it’s Q&A on Febrile convulsions and vaccines, the CDC states (excerpts):

 

• Febrile seizures are not uncommon. About 2%-5% of young children will have at least one febrile seizure.
• Most children who have febrile seizures recover quickly and have no lasting effects. However, febrile seizures often result in a visit to an emergency room and can be very frightening for parents and caregivers.

 

While no direct link to the Fluzone vaccine has been established, investigators will look into these reports further.

 

In the meantime, the CDC continues to advise parents to get their children over the age of 6 months vaccinated against influenza.

 

You may recall that last year in Australia a temporary moratorium was put in place on giving CSL Limited’s 2010 flu shot to children under the age of 5 after an unusual number of febrile convulsions were observed (see Australia Investigating Adverse Vaccine Reactions).

 

As a result, CSL’s exported pediatric vaccine Afluria, was not recommended for use in young children this year in the United States (see FDA Approves 2010-2011 Flu Vaccines).

 

Although these reports will likely be used as fodder by anti-vaccination advocates, it is important to remember that – on average - scores of children die every year in this country due to flu-related illness.

 

Vaccination, while not 100% effective, remains their best protection against influenza.

 

Here is a link, and some excerpts from, yesterday’s FDA notice.

 

Fluzone Vaccine Safety

FDA and CDC Update on Fluzone Influenza Vaccine and VAERS Reports of Febrile Seizures in Children

January 20, 2011

The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) routinely monitor the safety of all U.S. vaccines by using several vaccine safety surveillance systems, including the Vaccine Adverse Event Reporting System (VAERS). VAERS collects and analyzes information from reported adverse events (health problems or possible side effects) that occur after vaccination.

 

FDA and CDC have recently detected an increase in the number of reports to VAERS of febrile seizures following vaccination with Fluzone (trivalent inactivated influenza vaccine or TIV, manufactured by Sanofi Pasteur, Inc.). Fluzone is the only influenza vaccine recommended for use for the 2010-2011 flu season in infants and children 6-23 months of age. These reported febrile seizures have primarily been seen in children younger than 2 years of age. Data from VAERS are preliminary and serve as a sign or indication that further investigation is warranted. Further investigations are under way to assess whether there could be an association between influenza vaccination and febrile seizures, or if other factors could be involved. FDA and CDC have seen no increase in VAERS reports of febrile seizures in people older than 2 years of age following vaccination with TIV, and no increase after live attenuated influenza vaccine (FluMist, the nasal spray vaccine). In the cases reported, all children recovered and no lasting effects have been seen.

 

Recommendations for the use of flu vaccine in children have not changed.

 

FDA and CDC will continue to conduct studies and provide additional information to the public and health care providers as it becomes available.

(Continue . . .)

Vaccines: Weighing The Risk/Reward Ratio

 

 

 

Note: This week is National Influenza Vaccination Week (NIVW).   Today is my attempt to put the risks of vaccination in perspective.

 

# 5122

 

 

Practically every time I mention vaccines in this blog (which is pretty often), I end up with 1 or 2 scathing comments about the `evil’ vaccines do, and links to the usual suspects that peddle vaccine paranoia.

 

Those comments almost always end up deleted, since they offer little more than vaccine vitriol and the same tired arguments. Invariably they contain a reference to someone whose life was seriously disrupted by a flu vaccine.   

 

In the ultimate personification of irony, I know smokers who refuse the vaccine each year because they don’t know what `poisons’ might be in it.

 

But as I’ve pointed out in virtually every vaccine essay I’ve written, vaccines are not 100% safe or completely benign.  

 

 

They can have side effects. Sometimes, albeit rarely, those side effects can be serious.

 

And that is true for all medicines, medical procedures, and just about everything you ingest in life.

 

I almost died at the age of 17 from an anaphylactic reaction to penicillin.  It took a trip to the ER, and IV epinephrine, to alleviate the crisis. That doesn’t make penicillin a bad drug, it is just the wrong drug for me (and others with a similar allergy).

Even aspirin and NSAIDs – sold over the counter – contribute to thousands of hospitalizations and deaths each year.

 

There are risks in just about everything you do.

 

As I’ve said before, if you want a guarantee in  life . . . buy a Craftsman.   

 

Today Fergus Walsh, BBC’s medical reporter and blogger, has a terrific essay called:

 

Aspirin, cancer risk and a personal decision

 

This is an interesting article on cancer and the potential protective effects of aspirin, but I highlight it because it illustrates quite well that we must always consider the downside to every medical decision we make.  

 

Even if it is something as seemingly innocuous as taking an aspirin every day.

 

We must weigh the risks against the potential reward and accept that all medicines are a double-edged sword.

 

Okay, back to the flu vaccine.

 

Last year in excess of 12,000 Americans are believed to have died from the Swine flu, and the CDC estimates there were roughly 274,000 pandemic flu related hospitalizations.

 

Overwhelmingly, those killed or hospitalized were under the age of 65.

 

Despite near-hysterical warnings over the safety of the pandemic vaccine, no deaths were attributed to the Swine flu shot (see CIDRAP VAERS study finds H1N1 vaccine safety similar to seasonal vaccines') and most reported side effects from the vaccine were minor, and temporary.

 

Only 726 serious adverse reactions were reported, out of more than 80 million shots given.

 

• 0 deaths from the Vaccine  vs 12,000 deaths from the flu.
• 726 severe reactions  vs.  274,000 flu hospitalizations

 

That’s the risk reward ratio to consider.  

 

Even if the vaccine were only 50% effective in preventing the flu, a greater uptake could have saved thousands of lives and tens of thousands of hospital stays.

 

The truth is, the benefits of the flu shot far exceed its risks. 

 

 

And that holds true every year, not just during a pandemic. 

Two Vaccine Related Stories From CIDRAP

 

 

# 4912

 

 

CIDRAP news carried two stories last night based two studies that appeared in the journal Vaccine late this week.

 

 

Adverse events following influenza A (H1N1) 2009 monovalent vaccine adverse events reporting system, United States, October 1, 2009--January 31, 2010

From Vaccine, published online Sep 16

Healthy young and middle age adults: what will it take to vaccinate them for influenza?

From Vaccine, published online Sep 15

 

The first is an update on the relative safety of the H1N1 pandemic vaccine rolled out in October of 2009, as measured by VAERS (Vaccine Adverse Event Reporting System).

 

When millions of doses of vaccines are administered, some small number of serious adverse reactions are expected. This is true for all medications, including those you can purchase over-the-counter.

 

All medicines have risks. 

 

Some are known, while others are so rare, we have trouble measuring them.  It is always a balancing act - a risk-reward calculation - when deciding to take any drug.

 

And the same goes for flu vaccines.  Serious side effects are exceedingly rare, but not unheard of. No one can promise you that a vaccine is going to be 100% safe.

 

But on the flip side, we know that somewhere between 12,000 and 18,000 Americans died from the H1N1 flu last year, and most of those were under the age of 65.

 

Which brings us to this first report by CIDRAP News Editor Robert Roos:

 

 

VAERS study finds H1N1 vaccine safety similar to seasonal vaccines'

Robert Roos News Editor

Sep 17, 2010 (CIDRAP News) – The 2009 H1N1 influenza vaccine generated more adverse-event reports than recent seasonal flu vaccines, but this was probably due in part to heavy publicity, and the vaccine's safety profile appears similar to that of seasonal vaccines, according to a new analysis by federal scientists.

 

The researchers, from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), found that serious adverse events (AEs)—particularly Guillain-Barre syndrome (GBS), anaphylaxis, and death—were rare, at less than two of each per-million people vaccinated, according to their early-release report in Vaccine.

(Continue . . .)

 

 

The second story is a news brief, essentially a summation of the the second study’s abstract, on the difficulty in persuading young adults to get a seasonal flu vaccination.

 

Persuading young adults to get flu shots seen as challenge

Healthy adults aged 19 to 49 years are for the first time this flu season (2010-11) among the groups recommended by the Advisory Committee on Immunization Practices (ACIP) to receive annual influenza vaccination. But, as stated by the authors of a study published in Vaccine, "Recommending universal vaccination is one thing; achieving it is another."

(Continue . . .)

 

Which reminds me, I need to get over to my local pharmacy this week and get my flu shot.