Focus on Flu

Our guest blogger is Norman H. Edelman, MD, the American Lung Association’s Chief Medical Officer for 25 years. Dr. Edelman also provides patient care as a teaching clinic supervisor and is a Professor of Preventive Medicine, Internal Medicine, and Physiology and Biophysics at the State University of New York at Stony Brook. He is also a national spokesperson for Faces of Influenza, a national influenza awareness initiative conducted in collaboration with the American Lung Association and Sanofi Pasteur..

During this time of year, questions start to crop up about the flu and I hear a lot of confusion and misinformation spreading around about the virus and the vaccine. Here are the more common questions and myths I hear:

“I never get the flu, so why should I get the flu shot?”

“I had the flu last year and it wasn’t that bad.”

“I don’t want to get the flu from the vaccine.”

The fact is, influenza is a serious infectious disease that can lead to hospitalization and death. Everyone is at risk of contracting the virus. And everyone 6 months of age and older is recommended for vaccination every year.

The key to understanding the flu is to educate yourself early. Go to reputable sources such as your own physician, the American Lung Association’s Faces of Influenza website, WebMD,  or the Centers for Disease Control and Prevention (CDC) to get the facts.

Vaccination is safe and effective, and the best way to help prevent influenza and its complications.

Our guest blogger, Julie Bowen, stars in the acclaimed hit ABC comedy Modern Family as harried suburban mom “Claire,” opposite Ty Burrell and Ed O’Neill. She is also the national spokesperson for Faces of Influenza, a national influenza awareness initiative conducted in collaboration with the American Lung Association and Sanofi Pasteur.

It is stories like Lisa Amoroso’s that remind me of my responsibility to protect my children and myself during flu season

Last fall, Lisa, age 40 and a mother of three, thought she had a bad cold.  But when it got worse after a few days, Lisa went to the doctor and was rushed to the emergency room.  Her organs started failing and Lisa was put into a coma to help save her life.  An otherwise healthy and active woman, Lisa had influenza and was severely ill for several months.

Lisa survived, but had a difficult recovery. Now, she and I are among many people who have teamed up with the Faces of Influenza educational initiative to help raise awareness about the importance vaccination against this potentially deadly disease.

I want to do everything possible to be the best mom I can be, including protecting myself and making sure I’m healthy enough to be there for my kids.  Looking out for my health has become as important as looking out for theirs — especially when it comes to influenza.  I would hate to think that something as easily preventable as the flu could keep me from my family.

That’s why I make sure we all get the flu shot every year.  By vaccinating, we take a simple step to help protect us against the flu, so we can get on with our very busy lives.

Learn from Lisa’s experience so you and your family don’t have to suffer the hardship that she and her family went through. Get vaccinated.

To read more about Lisa’s story and other Faces of Influenza, visit www.facesofinfluenza.org.

Our guest blogger, Julie Bowen, stars in the acclaimed hit ABC comedy Modern Family as harried suburban mom “Claire,” opposite Ty Burrell and Ed O’Neill. She is also the national spokesperson for Faces of Influenza, a national influenza awareness initiative conducted in collaboration with the American Lung Association and Sanofi Pasteur.

Hopefully by now you all know me as Claire on Modern Family.  But what you may not know, is that I’m also a “face” of influenza.

If fact, we all are “faces” of influenza and it is recommended that we all get vaccinated this and every year. Influenza is a serious health threat that can cause hospitalization and death. It’s easily spread, so we’re all at risk of contracting the virus.

If I get sick, I’ll have to miss work and the last thing I want is to pass the flu on to my husband and three little boys.  That’s why I make sure everyone in my household gets vaccinated.

If you haven’t gotten your flu shot yet, do it now.  It only takes a minute and in about two weeks you will be protected against the flu virus.

And for those of you who are afraid of getting shots — it really doesn’t hurt.  I was so proud of my boys this year as they each got the vaccination without one tear.  The pediatrician made it super easy for us too — he vaccinated my husband and me when we took the boys for their shots.  But these days, you can get the flu shot practically anywhere.

To learn more about Faces of Influenza, visit www.facesofinfluenza.org.

Our guest blogger is Kathleen Sebelius, Secretary of the Department of Health and Human Services (HHS). As Secretary, she leads the principal agency charged with keeping Americans healthy, ensuring they get the health care they need, and providing children, families, and seniors with the essential human services they depend on. As the country’s highest-ranking health official, she has been charged by the President with coordinating the response to the 2009 H1N1 flu virus.

This week is National Influenza Vaccination Week, and it’s a great time to get vaccinated against the H1N1 flu.

Flu is unpredictable, and this flu season is far from over. Flu season typically lasts until May, and we don’t know whether there will be additional waves of flu illness. H1N1 is still circulating, it’s still dangerous, and there are still lives to be saved. That’s why it’s so critical for everyone to get vaccinated.

While over 60 million people have received the H1N1 vaccine, over three-fifths of Americans have not yet gotten it. It’s easy to find a flu vaccination location near you. Simply visit Flu.gov and type your zip code into the flu vaccine locator tool.

One of the many goals for this week is to engage at-risk, unvaccinated audiences who are concerned about vaccination or unsure about where to find vaccine. In an effort to reach more Americans, each day this week we will highlight the importance of getting a specific group vaccinated:

General Public and Health Care Workers
Monday, January 11 is the official vaccination day for both health care workers and the general public. Now that more H1N1 vaccine is available and high-risk groups have had the opportunity to get vaccinated, anyone 6 months or older in the general public is encouraged to get vaccinated against H1N1 flu. Health care workers are among those at higher risk of getting and spreading the flu.

People with Chronic Health Conditions
Tuesday, January 12 is the designated vaccination day for people with chronic health conditions. Because of their underlying conditions, they’re at higher risk of serious influenza-related complications. Those high-risk conditions include asthma, diabetes, heart disease, kidney and liver disorders, neurological disorders, blood disorders, cancer, HIV or AIDS, and others. The flu can make chronic health problems worse.

Children, Pregnant Women, and Families
Wednesday, January 13 will highlight the importance of getting H1N1 vaccine for pregnant women, children, and caregivers of children less than 6 months of age.

2009 H1N1 flu is very serious for these three groups. A woman who is vaccinated during her pregnancy can reduce the risk of influenza for her and for her baby. Children of all ages are at high risk for contracting the influenza illness, especially children under the age of two. The best way to protect these children is to make sure their caregivers and other adults and children who live with them get vaccinated.

Young Adults
Unlike seasonal flu, the H1N1 virus has spread quickly among young adults age 19 to 24. Thursday, January 14 will focus on vaccinating people in this age group. Young adults have been hit extremely hard by 2009 H1N1 this year. Since many young adults have regular contact with a large number of people – whether it’s their families, workplace, or classrooms – they are more likely to expose themselves and their loved ones to this virus. Vaccination is important not just for their health, but for the health of those around them.

Seniors
The CDC now recommends that senior citizens get the H1N1 flu vaccine. While seniors are less likely to be infected with the H1N1 virus than younger people, there have been severe infections and deaths from H1N1 in every age group, including people 65 and older. Friday, January 15 has been designated Seniors’ Vaccination Day, a reminder that older Americans who want to lower their risk of infection and flu-related complications should now get the 2009 H1N1 vaccine.

Thank you for helping us spread the word about National Influenza Vaccination Week. Together we can fight the flu, and keep our families, neighbors, coworkers, and communities healthy. If you would like to get involved in this event, visit the NIVW website.

Guest blogger Matthew Hoffman, MD, has written for WebMD since 2006. He is a board-certified internist and is currently a fellow in pulmonary and critical care medicine at Emory University, where he also completed medical school and residency.

It’s surprising – and to me a bit exhausting – to realize that H1N1 influenza has been with us for 10 months now. Unlike those daily minor health scares that sometimes seem invented for the 24-hour news cycle, H1N1 influenza has become a persistent serious public health problem. And although we’re seeing a drop in cases of H1N1 flu, there’s still no end in sight.

As we start 2010, let’s catch our breath. Take a look back with me at the time line of H1N1 influenza’s path from discovery to worldwide pandemic in 2009:

March: Doctors take specimen samples from three children in Mexico and southern California with respiratory infections. (All three children recover completely.)

April: Centers for Disease Control and Prevention realize the children were infected with a never-before seen flu virus. The same day, the first recognized death from H1N1 influenza occurs in Mexico.

May: H1N1 flu spreads to every region of the U.S., affecting more than 1,000 people here and 10,000 worldwide. Work on a vaccine begins; the government plans its response.

June: A global pandemic is declared as H1N1 spreads to 74 countries. The World Health Organization (WHO) declares the virus “unstoppable.” The known worldwide death toll reaches 144.

July-August: Clinical trials of an H1N1 vaccine begin in Australia and the U.S. The U.S. Department of Health and Human Services (HHS) allocates $350 million in grants to state and local health agencies. H1N1 cases among students rise as they return to school.

September: The FDA approves four vaccines against H1N1 influenza, and initial clinical trial results show one dose of the vaccine is effective (except in children aged 9 and under, who need two doses).

October: H1N1 explodes in the U.S., spreading from 26 states into 46. The death toll in U.S. children and teens reaches at least 95. HHS releases for distribution 300,000 doses of Tamiflu, an anti-influenza drug. President Obama declares H1N1 a national emergency, allowing states and hospitals to take special measures to prevent and treat H1N1 flu.

November: Confirmed deaths in children and teens with H1N1 influenza reach 198, but CDC estimates the true total to be more than 500. Demand for the vaccine rises – but production problems limit supply, creating widespread shortages.

December: More than 60 million doses of H1N1 vaccine become available, just as H1N1 flu activity begins to decline in many areas of the U.S.

Although H1N1 flu will soon have been with us for a year, it’s still unpredictable. For example, (according to my research) experts still can’t explain why H1N1 influenza persists throughout the seasons, unlike seasonal flu’s predictable cycles. So far, no one is predicting H1N1 flu will be with us permanently, but the CDC is expecting (or at least planning for) further surges in activity in 2010.

So if you haven’t yet, make a resolution to get to your local pharmacy or doctor’s office and get your H1N1 influenza vaccine. There’s plenty to go around now, the vaccine can save your life, and no one knows what’s coming from H1N1 flu in 2010.

SOURCE: “H1N1: Meeting the Challenge.“

by Rod Moser PA, PhD, a primary care physician assistant with more than 35 years of clinical experience.

Cases of H1N1 influenza in my office have diminished. We were getting several dozen cases a day in early December, but now only seeing a few, random people with characteristic symptoms of influenza. We are not rapid testing “obvious cases” but will test for Type A influenza if there are any diagnostic doubts or if the patient or family insists. Experts hope that this lull in cases will be permanent, but also fear that this may be the calm before the storm – the next wave of cases expected after the busy, travel holidays. As always, diseases are as unpredictable as the people who get them.

I can’t say that we have seen the usual, garden variety, seasonal flu strain yet, but I do not doubt the virus is lurking around out there. Since the seasonal strain historically causes most of the cases and deaths, it is important to keep on high alert. Last year, seasonal strains did not rear their ugly heads until February in our practice. It hung around causing havoc for a month or so then went away. I hope this will the case this year as well.

I think we are more prepared now than ever before. We have hand sanitizing stations everywhere in our office, maybe a hundred. We have a “flu station” with masks, information, and more sanitizers. We isolate suspected cases from others. I see medical assistants scrubbing off chairs, tables, door knobs, faucets, etc. all day long. After each patient leaves the exam room, the room is sanitized. I have to say, that before H1N1, these expected hygienic practices were not as diligent and thorough. There is nothing like a good pandemic to get your attention and challenge your customary practices.

If the H1N1 Pandemic did anything, it raised public awareness of this stealthy killer among us. The population at large sees the importance of vaccination, and for the most part, trusts these public health efforts. There were no flu vaccines in 1918 when the Spanish Flu Pandemic swept across the globe, killing the young and old with lightening speed. Now, we have the means of preventing influenza, but the science is far from perfect, namely because viruses are so terribly unpredictable. We do tend to learn from our past mistakes. If we don’t we get to do those wrong things again…and again.

Because I am on the front line (a large percentage of my available appointments are for same-day, urgent visits), I needed the break from working these 14 hour days. I was tired of making excuses as to why we didn’t have any vaccines…or enough vaccines….or the right vaccine (mist or injection). Our supplies have increased now, so most people who want the vaccines will be able to get them. We had a huge waiting list needing vaccines; vaccines that were not delivered to us in a timely manner.

I heard stories of patients going from pharmacy to pharmacy trying to fill Tamiflu prescriptions. One pharmacy (one that I will not be using anymore) charged some of my patients a “compounding fee” of $75 extra per prescription when they ran out of the liquid formulation of Tamiflu for children and had to open an adult capsule and mix it with some cherry syrup! That was so exploitive. Yes, compounding takes a little more time, but in a pandemic, it should have been a criminal offense to hold medicines captive in order to make a few extra bucks. I bet that some parents on a tight budget in this economy gave up a lot of things just to pay for these prescriptions.

It broke my heart to see people – old people in walkers or pregnant mother’s pushing strollers and holding children’s hands – standing in long lines for vaccinations. We are a rich country. We are a smart and proactive country. We are also a country that tends to be caught time and time again with our pants down, from breaches of airport security to our public health efforts. I love when the experts jump in AFTER the fact, explaining what went wrong. Great, now fix it.

I am not a big fan of fully, socialized medicine, but I am a fan of a socialized public health system. Immunizations should be free (paid for by the government) for everyone, and readily available. Money spent in these efforts to have an ample supply of safe, well-tested vaccines will save thousands of lives, and umpteen millions in health care costs. Don’t they see this? Vaccines are condoms. Vaccines are seat belts or motorcycle helmets. Vaccines are policemen and firemen. Vaccines are the brave men and women in our military.

There will always be wackos out there claiming that vaccines are a government plot to control us, or that even the flu vaccine causes autism. Perhaps we can’t shove vaccines into the arms and up the noses of all people in a free-society, but we can do better. We can try harder next time through ongoing, well-funded, scientific research and public education.

For the militant, vaccine-refusers, I wish them the best. I hope they don’t get sick, or die. If they do get sick, I hope they don’t freely share it with innocent people who will get sick and/or die. And, I hope I don’t have to pay for their paranoia and mistrust, directly or indirectly. I hope that someday they will do their part – their share – to protect the population from unnecessary illnesses. For those of us who do get vaccines, who do see the benefits, who do take those tiny risks of vaccine side effects, I hope we get the “thanks you’s” for doing an important part in strengthening our human herd.

by Anthony Fiore, MD, MPH, medical epidemiologist for the Influenza Division of the CDC.

What a difference a few weeks makes!

Influenza activity has decreased by all measures from the national perspective, although some communities are still seeing widespread flu, almost all of it 2009 H1N1 flu. This means that fewer people are getting sick, and fewer are getting hospitalized, than we saw in September through November.

Is the virus gone? Certainly not yet. In fact more than 99% of flu viruses isolated in December were still the 2009 H1N1 virus. Furthermore, influenza viruses are predictably unpredictable. Flu will probably continue to circulate through the winter months, caused by either 2009 H1N1 viruses or regular seasonal flu viruses. If the 2009 H1N1 virus behaves like other new flu viruses, it intends to stick around.

The good news is that the supply of 2009 H1N1 vaccine has increased dramatically, and in many areas vaccination is being offered to anyone who wants it. As of December 18 the number of doses available had increased to more than 100 million, and manufacturers project another 10 million to 15 million doses each week through January. In some areas however, public demand among priority groups has stayed high, so not every area has been able to open 2009 H1N1 vaccination up to all-yet. That has happened in part because public interest in getting vaccinated has varied a good bit state-to-state.

We still have a long way to go before everyone who wants to be vaccinated has a chance to. Many people, including many among those who were designated to get the limited doses that were initially available, have not been vaccinated yet. As of early December, an estimated 46 million people (15.3% of the population) had been vaccinated against 2009 H1N1 flu. This represents 28 million adults (13% of the total) and 18 million children (24% of the total) who have received the 2009 H1N1 vaccine.

Now that vaccination has been expanded in many areas to include most or all of the population, let’s review what we know so far about who is most at risk if they get 2009 H1N1 influenza:

1. Infections, including severe infections, among children and young adults continue to be more common than we usually see with seasonal influenza.
2. While people 65 or older are less likely to get flu caused by 2009 H1N1 flu, those that do become infected are at greater risk of having serious complications from their illness. Some outbreaks among older people living in long-term care facilities also have been reported. Sometimes these outbreaks have also involved health care workers in the facility – a reminder that regardless of what population a health care worker provides care for, vaccination is very important.
3. Adults younger than 65 years old who have chronic medical conditions such as asthma, heart disease, or neuromuscular conditions are at higher risk of severe illness. There have been many more deaths among persons aged 18-64 than any other age group, and most of those persons have had one or more chronic condition.
4. Data from several studies suggest that obese people (particularly those who are very obese) are also at increased risk of severe flu complications. This group has not previously been recognized to have a higher risk of severe flu.
5. American Indians/Alaskan Natives also appear to be at higher risk.

It’s not yet clear why the higher risk for severe illness in these last two groups, but possible reasons may include being more likely to also have a chronic medical condition that increases their risk of severe illness, less access to early medical care, or something else unique about this virus for those groups. Regardless of the cause or causes, those who are obese or who are an American Indian or Alaskan Native should get vaccinated as should others recommended for 2009 H1N1 vaccine as vaccine becomes available.

Finally, I want to remind everyone about two other groups of people we have been focusing on since the start of the vaccine campaign: children and pregnant women. For 2009 H1N1 vaccine, children younger than 10 years old need to get 2 doses of vaccine.

No doubt pregnant women and their families are weary of hearing about their need to get vaccinated. But we still are seeing severe illness in pregnant women, and it has been shown that when Mom gets vaccinated both mother and infant benefit. We don’t have a vaccine for children less than 6 months old, so anything that can be done to protect them is important.

Now, with a greater supply of the 2009 H1N1 influenza vaccine, it’s quite likely that you can get vaccinated at your doctor’s office. Or, go to one of the retail pharmacies or your local health department. Some large retail stores now have 2009 H1N1 vaccine also. CDC recommends that anyone who wants to be protected from the 2009 H1N1 virus be vaccinated, regardless of age, as soon as vaccine is available for all in their community. The flu season is not over yet.

Our guest blogger is Georgina Peacock, MD, MPH, Medical Officer Senior Service Fellow with the Prevention Research Branch in the Centers for Disease Control and Prevention’s National Center on Birth Defects and Developmental Disabilities.

As parents, we are always on our guard. But if our little ones are living their lives, going to school or playing at the playground, insistence on hand washing and covering coughs may not be enough to protect them against the 2009 H1N1 flu virus. Children under six months are too young to receive the flu vaccine, and they are among the most vulnerable to developing serious complications from flu, including hospitalization and sometimes even death. And if your child has an underlying health condition like asthma, a neuro-developmental disorder or diabetes, you need to take extra precautions because they are also at high risk for complications. Vaccination against 2009 H1N1 is key to protecting them, and as a pediatrician, I urge families to make sure their children get vaccinated, and if they’re too young (under 6 months) – then vaccinate family members and caregivers to ‘cocoon’ them from the virus.

Here’s why: flu takes a big toll on children, especially young children. Each year in the United States, an average of 20,000 children younger than five years old are hospitalized, and around 100 children die because of complications from seasonal flu. With the spreading of the 2009 H1N1 influenza virus, the Centers for Disease Control and Prevention (CDC) estimates that roughly 10,000 people may have already died from complications related to 2009 H1N1 – and many have been children and young people. Vaccination against 2009 H1N1 is recommended for all children, teens and young adults, ages 6 months to age 24 and is increasingly available through state health departments, pediatrician offices and health clinics.

And if you’re wondering about the safety of the vaccines, know that they are safe and cannot give your child the flu. Over the years, hundreds of millions of Americans have received seasonal flu vaccines and have an excellent safety record. So far, the 2009 H1N1 flu vaccine has the same safety record as the seasonal flu – and it’s produced just like the seasonal flu vaccines that are made every year. The CDC and the FDA closely monitors all vaccines for safety and has done so for many years. For more information on the safety of the vaccine against 2009 H1N1, please visit the CDC’s vaccine safety page.

You may have heard last week that some batches of pediatric vaccine against 2009 H1N1 that were in pre-filled syringes have been recalled because their potency had decreased, something that is still being looked into. Please be assured that this is NOT a safety recall – and that if your child had received a dose from the recalled batch that they do not need another dose and that they are still protected. For more information about this, please visit CDC’s Q&A; page on the topic.

For the 2009 H1N1 flu vaccine, all children under 10 should receive two doses to be fully protected. The second one should be given four weeks after the first dose.

It’s impossible to predict what will happen with the 2009 H1N1 virus and how long it will be around – so please don’t risk it. With most of the fatalities being children and young adults, we need to make sure we protect them. So keep informed, wash your hands often, cover your coughs and sneezes, keep sick children at home and vaccinate your family against 2009 H1N1.

For more information about the flu vaccines, contact your state public health department, visit www.flu.gov or www.cdc.gov/flu or call CDC at 1-800-CDC-INFO (800-232-4636).

Our guest blogger is Ari Brown, MD, a fellow of the American Academy of Pediatrics. She works full-time in private practice in Austin, Texas.

When the newswires reported Tuesday that 800,000 doses of the H1N1 vaccine, my office’s phone lines started ringing off the hook. If you have a child who received the H1N1 vaccine, keep on reading.

First of all, this was NOT a recall for safety issues. The particular vaccine, made by Sanofi-Pasteur, was recalled because it may not be potent enough for a person receiving the vaccine to mount an adequate immune response. So, any unused doses sitting in doctors’ offices and clinics need to be discarded.

Specifically, there are four batches or “lots” of single-dose, pre-filled syringe thimerosal preservative-free Sanofi brand vaccine intended for children ages six months to three years of age that are being recalled. The batches (lots) are: UT023DA, UT028DA, UT028CB, and UT030CA.

Now, the next natural question is, what do you do if your child did receive one or two doses of this particular H1N1 vaccine? Nothing. Don’t worry about it. Officials at the Centers for Disease Control believe that kids who got this vaccine likely have adequate protection because the potency of the vaccine is only marginally less that the desired level found to be effective in vaccine testing. So, you do not need to call your child’s doctor and ask if your child received one of these vaccine batches or request that your child receive an additional H1N1 booster shot to ensure protection. (Maybe I should put that last sentence in bold print!)

The 800,000 doses of this H1N1 vaccine is only about 1% of the entire vaccine manufactured. There are other H1N1 vaccine products that are available to use if your child still needs to get a first/second dose.

And yes, I still recommend that your child get vaccinated against H1N1 disease. I’m concerned that the holiday travel season may enable this germ to spread around.

Speaking of which, here are a few tips during winter travel season:

1. Be obsessive about hand washing, especially with air travel. Take hand gel or antiseptic wipes in your carry-on bag so you and your kids’ hands can be cleaned before they munch on those yummy on-board snacks.
2. If your child has a fever, isolate him from others until he is fever-free. If you have family gathering for holiday celebrations, taking home an illness is one gift everyone can live without.
3. If you are leaving town, find out if your child’s doctor has a colleague she can refer you to in your destination-just in case. Kids always pick weekends, holidays, and exotic destinations to get sick! You don’t have to head to an ER or minor emergency clinic just because you are visiting from out of town.

by Anthony Fiore, MD, MPH , medical epidemiologist for the Influenza Division of the CDC.

Like everything having to do with 2009 H1N1, there has been lots of attention on 2009 H1N1 vaccine safety – and now that the vaccine has been available for a while, it’s a good time to check in with the vaccine safety experts responsible for monitoring the reports of health problems (“adverse events” is the official term) after getting the H1N1 vaccine. These initial reports are very reassuring.

On December 4, CDC and FDA released the first of several planned comprehensive studies of safety information available so far. The bottom line: the types and frequency of health problems reported for the 2009 H1N1 flu vaccines are about the same as those we typically see among people who get seasonal influenza vaccines. The safety information we have so far is based on the first 46 million doses of 2009 H1N1 vaccines that were distributed in the United States through November 24, and the number of reports is quite low considering how many doses have gone out.

The studies have found:

• Up to November 24, 2009, the U.S. Vaccine Adverse Event Reporting System (VAERS) had received 3,783 adverse event reports following 2009 H1N1 vaccination.
• Nearly all (95%) of adverse events reported to VAERS after receiving the 2009 H1N1 vaccine were typical short term side effects (e.g., soreness at the vaccine injection site).
• Of the 3,783 reports, 204 (5%) were reports that involved what would be considered serious health events (defined as life threatening or resulting in death, major disability, abnormal conditions at birth, hospitalization, or extension of an existing hospitalization).
• The percentage of reports involving serious health events is not substantially different between 2009 H1N1 and seasonal influenza vaccines. Additionally, no new or unusual events or pattern of adverse events have emerged. VAERS reports continue to be monitored as more vaccine is administered.
• The 13 VAERS reports that involve deaths are under review by CDC, FDA and the states where the reported deaths occurred. Preliminary findings do not indicate a common cause or pattern (such as similarities in age, gender, geographic location, illness surrounding death, or underlying medical conditions) to suggest that these deaths were associated with the vaccine. These might have just been due to chance or bad luck – for example, 1 death that occurred after vaccination was due to a motor vehicle accident. These cases are under further review pending additional medical records (e.g., autopsy reports, medical files).
• VAERS received 10 reports of Guillian-Barré syndrome (GBS), and follow-up assessments are underway. An additional 2 reports describing neurologic events are also under review as possible GBS. Remember that GBS can occur for a variety of reasons. In the United States, about 80-160 cases of GBS are expected to occur each week, regardless of vaccination. So it’s not clear that any of these cases of GBS were due to the vaccine.

So what does this mean?

The most reasonable interpretation is that 2009 H1N1 vaccines are not substantially any more or less safe than the seasonal flu shot or nasal spray vaccines available every year. The number of reports is quite low considering that nearly 50 million doses have gone out.

How is the vaccine safety information gathered?

The CDC and FDA review vaccine safety results from two different monitoring systems that have been used for nearly two decades. First, data from reports received through the VAERS are analyzed. VAERS is a voluntary reporting system established in 1990 through which anyone can report an event that happened after vaccination. Approximately 30,000 VAERS reports are filed each year.

Experts also analyze data that comes through the Vaccine Safety Datalink (VSD) which includes 8 large managed-care organizations that provide care for about 9.5 million people around the country. Reports received through VAERS can be thought of as a way to look for signals that might need to be investigated further, and many reports of serious adverse events are reviewed quite thoroughly, including looking at medical records.

Experts suspected that more people than usual would report things that happened after getting the vaccine, and CDC and FDA had encouraged reporting this season because they did not want to miss any early signals. This might explain why there are more VAERS reports per persons vaccinated for the 2009 H1N1 vaccines than for seasonal vaccines. But the very low number of serious events, and the lack of any signal in the VSD- which is our “gold standard” system for comparisons – is reassuring.

There is also another group working to independently evaluate 2009 H1N1 vaccine safety called the National Vaccine Risk Assessment Working Group. Members include people outside of the Federal government who are experts in internal medicine, pediatrics, immunology, or vaccine safety. The group is meeting every two weeks and will provide reports to the public after considering data from the many safety monitoring systems. To keep following the vaccine safety story, check back every week or two with the Vaccine Safety page at CDC.