Why Do People Fear the New Flu Vaccine?

[David Baxter PhD]

2 flu shots at same time OK in U.S.
CBC News
Friday, October 9, 2009

Getting both the H1N1 and seasonal flu shots at the same time seems safe and effective, a U.S. health official said Friday.

Clinical trials in the U.S. are testing the vaccines on 400 healthy adults and 400 seniors.

The first results on 50 people who were given both the seasonal flu shot and the pandemic vaccine at the same time ? one in each arm ? showed both vaccines worked effectively at immunizing people, Dr. Anthony Fauci of the U.S. National Institute of Allergy and Infectious Diseases, told reporters.

"The vaccine when given simultaneously does not impair the immune response to either of those [shots]," Fauci said.

"That I believe is going to be important as we roll out the vaccination program. And individuals will go to their offices and would like at the same time to get both vaccinations."

Other findings suggested a single,15-microgram dose of the vaccine "would be sufficient for the adults and elderly," he said.

And there were no serious side-effects, just the usual redness and soreness in the arm that is often seen with injected vaccines.

Fauci also announced that the institute is launching new trials to study the safety and effectiveness of the vaccine in people with asthma, pregnant women and people who are HIV positive.

The U.S. started inoculating healthy people against H1N1 this week using a nasal spray form of the vaccine that is not approved for use in Canada.

Canada may start vaccinating people against the pandemic strain in two weeks, if regulators are satisfied the shot is safe and no quality control issues are found.

 

[Retired]

5 Reasons Some People Fear the Swine Flu Vaccine
By Daniel J. DeNoon
WebMD Feature

Fear No. 1: Getting Swine Flu From H1N1 Swine Flu Vaccine
Family doctors hear it all the time -- it's the No. 1 fear of flu vaccines, says Ted Epperly, MD, president of the American Academy of Family Physicians.

"The public has a large fear that somehow flu vaccine gives people the flu," Epperly tells WebMD. "They have this fear they will get the disease this vaccine is aimed at preventing."

We've all heard this. Many of us have experienced it firsthand. Flu season comes, so you get your flu shot. A day or two later, you come down with "the flu." It had to be the flu shot, right?

Scientists know that just because two events happen in sequence doesn't mean one caused the other. But that isn't how it feels when it happens to you.

All the same, flu is caused by a virus -- and there's no virus in the flu shot. As for the FluMist nasal spray vaccine, there is a live virus, but it can't cause full-blown flu.

"There is no scientific evidence for -- absolutely no truth -- to the urban myth that vaccine will give you the flu," Epperly says.

So why do so many people report getting the flu after a flu shot? The answer is that the flu isn't the only flu-like illness going around during flu season. In fact, influenza accounts for less than a third of flu-like illnesses during flu season. We just tend to call them all "the flu."

But since people who are vaccinated don't get the real flu, they actually suffer less flu-like illness than people who don't get their flu shot or sniff.

"Some people ask, how do you know that what they perceive is not true?" Omer says. "But we do know flu vaccine doesn't cause flu because the better comparison is to look at what happens to people who get the vaccine vs. those who don't -- and there are far fewer flu-like illnesses among the vaccinees

Fear No. 2: Swine Flu Vaccine Is Too New to Be Safe
People who worry about the safety of the H1N1 flu vaccine are doing just what medical experts have always told them to do -- weigh the real risks of any treatment against the real benefits you can expect.

How is that possible with a new vaccine? The answer is that the H1N1 swine flu vaccine is not as new as it seems.

If the H1N1 swine flu vaccine were a truly new product, it would have to go through years of safety testing before getting FDA approval. The fact that there already is an FDA-approved H1N1 swine flu vaccine doesn't mean corners were cut, says Frieden.

"The concern is that the vaccine may not be safe, that corners may be cut, that short cuts may have taken, that it's a new or different vaccine," Frieden says. "In fact, none of that is the case. The vaccine is made in the same way it's made each year. ... It's made in the same production facilities with the same companies with the same methods as it is made each year. Hundreds of millions of doses have been given."

What's different about the H1N1 swine flu vaccine is that the viral particle recognized by the immune system -- the vaccine antigen -- comes from the "H1" part of the swine flu virus rather than the "H1" part of the seasonal flu virus. H1 can't give you the flu and is not toxic.

But what about the swine flu vaccine of 1976? As many people now recall, there was a flu vaccine in 1976 that might have had safety issues. That vaccine may have triggered a rare but devastating neurological syndrome called Guillain-Barre syndrome (GBS) in as many as one in 100,000 vaccine recipients -- and 44 million people got that vaccine.

"In the mid-1970s, when that swine flu vaccine was given, there were about 25 to 50 cases of GBS," Epperly says. "GBS is a demyelinating neuropathy. People don't know what that is, but it's left a lingering fear the 2009 H1N1 vaccine may do more harm than good."

It's still not clear what happened in 1976. Some scientists say the vaccine wasn't linked to GBS, others say it was. But there have been huge improvements in flu vaccine production since 1976. There's much better testing for contaminants such as the suspected bacterial contaminant in the 1976 vaccine. Viral particles are purified differently. And quality testing is greatly enhanced.

Moreover, the 2009 H1N1 swine flu is a very different bug than the 1976 swine flu. For one thing, it's causing a very real pandemic. The 1976 virus never broke out of the army base where it was first detected. Historians have called it "the pandemic that never was."

No matter how small the risk of the 1976 vaccine, there was zero benefit. That's not the case now. Hundreds of Americans already have died of 2009 H1N1 swine flu, and the bug already has circled the globe. Nearly every nation on earth would like to have as much of the vaccine as the U.S. has.

Vaccine supplies in many nations -- Canada and the U.K., for example -- have approved the use of a substance called adjuvant to boost immune responses to the vaccine. This oil-in-water emulsion is approved by European regulatory agencies, but not yet by the FDA.

Consequently, no adjuvant is being used with the U.S. H1N1 swine flu vaccine. The U.S. does have a large supply of adjuvant. It might be used if the virus mutates and a broader immune response is needed for vaccine protection. But that has not happened yet, and may never happen at all.

Fear No. 3: I Never Get the Flu and Besides, It's Just the Flu
Some people say they never get the flu. It's hard to argue that they will -- although studies find that very few people have any pre-existing immunity to the 2009 H1N1 swine flu.

"I can't look at you and say what is your risk profile by how many times you say you wash your hands and so on," Omer says. "But on average, flu vaccine benefits people by preventing infection or at least preventing more severe consequences of flu. It helps -- especially among the groups for whom the vaccine is particularly recommended."

The Harvard poll shows that 61% of Americans planning to refuse the H1N1 swine flu vaccine don't think they're at risk of a serious case of swine flu.

"Actually, on average, flu is not a mild illness. It can make you pretty sick; knock you out for a day or two or three," Frieden says. "And for too many people, it ends up sending them to the hospital or to the intensive care unit -- and, tragically, some people may die from it. ... It can be very serious. And even for those for whom it's an average case, it's no picnic."

Fear No.4: It's Too Late: H1N1 Swine Flu Already Is Here
Even if you haven't been paying much attention to the news, you can't miss the fact that swine flu already is sweeping the nation. The average American won't get the vaccine until mid-November. Isn't that too late?

"It's too soon to say it's too late," Frieden said.

How can that be? The reason is that not everyone gets the flu at the same time. Even in areas where there's been widespread swine flu, studies suggest that about 5% to 10% of the population has been infected.

"That leaves 90% to 95% of the population still susceptible," Frieden says. "We can't predict what the future will hold and we know that vaccination is our best tool to reduce the impact of flu."

Fear No. 5: Ouch! Everyone Hates Shots
It's a dirty little secret that nobody likes getting jabbed in the arm.

"People just don't like getting shots," Epperly admits.

Indeed, 35% of people in the Harvard poll listed this as a reason they won't get their H1N1 swine flu vaccine.

There's no real answer to this, except to say that it only hurts a little -- and that the FluMist spray vaccine is also available for the H1N1 swine flu.

 

[Andy]

I don't mind needles myself but is that FluMist spray vaccine allowed in Canada? I was under the impression that it wasn't. That mist sure would be great though, for those with a fear of needles.

 

[Retired]

is FluMist spray vaccine allowed in Canada?

*Astra Zeneca has filed a "New Drug Submission" (NDS) with Health Canada in August 2009.

The status of that submission is not clear at this time, but we will follow the news to report information as it becomes available.

FluMist is available in the U.S.

*Source: The Medical News

 

[David Baxter PhD]

So why do so many people report getting the flu after a flu shot?

Additional reasons:

1. It takes time for you to develop immunity after a flu shot (perhaps 2-4 weeks, give or take). Even if you do come down with the flu a few days or a week after a flu shot, all that means it that you got the vaccination too late: You really need to be getting the shot before the "flu season" starts.
2. There are many variants of the flu virus. In any given year, health officials with the help of epidiomologists try to evaluate global trends and predict which are the most prevalent strains for the coming season. If you are exposed to a strain that is quite different from the ones in that year's vaccine, you may not be protected against that specific strain or variant.

 

[Retired]

I got my seasonal flu shot today, and will get the H1N1 vaccine as soon as it becomes available.

It's just not worth the risk to myself and to others.

:2thumbs:

 

[David Baxter PhD]

 

[David Baxter PhD]

As Flu Vaccine Arrives for the Season, Some Questions and Answers

As Flu Vaccine Arrives for the Season, Some Questions and Answers
By TARA PARKER-POPE, New York Times
October 10, 2009

The first doses of vaccine for the H1N1 2009 influenza, commonly called swine flu, began arriving at hospitals and doctors? offices this week. But fear and confusion about the vaccine are spreading almost as quickly as the virus itself.

The earliest vaccine shipments came in the form of a nasal spray, which is now a priority for health care workers and children. The number of children who have died of the new virus climbed rapidly to 76 this week, already nearing the 88 child deaths for the entire 2007-8 flu season. A flu shot form of the vaccine is expected next week.

Web sites and talk shows are abuzz with worries that the government rushed the vaccine. The comedian Bill Maher recently told his 60,000 Twitter followers that people who took flu shots were ?idiots.? Consumer Reports recently released a poll showing that only 35 percent of parents surveyed would definitely have their children vaccinated. Undecided parents said they worried that the vaccine was new and untested.

So what are the facts? Here are answers to some commonly asked questions about the new flu virus, regular seasonal flu and the two flu vaccines intended to prevent them both.

Q: What?s the difference between the seasonal flu that occurs every winter and this new H1N1 flu virus?

A: Seasonal flu comes back in slightly different forms each year. But the H1N1 2009 is an entirely new combination of four genetic elements: a bird flu, some human flu genes and two types of swine flu. The H1N1 2009 virus, which has spread worldwide, was surprisingly robust during the spring and summer months. Right now, about 90 percent of the circulating flu is H1N1, although seasonal flu, which typically peaks in winter, has also been detected.

Q: What is the difference between the two flu vaccines?

A: The H1N1 2009 vaccine contains only the novel H1N1 virus. This year?s seasonal vaccine contains three influenza viruses ? one A (H3N2) virus, one regular seasonal A (H1N1) virus unrelated to the swine flu strain and one B virus.

Q: I?ve heard that the new flu strain circulating this fall is mild. Why should I have my child vaccinated?

A: When it became clear last spring that the pandemic H1N1 strain would not be as deadly as once feared, health officials reassured a nervous public that most H1N1 infections had been ?relatively mild.? It created the false perception that H1N1 is not a life-threatening illness. While most people who get H1N1 are sick for three or four days and then recover, a recent New England Journal of Medicine study showed that among Americans hospitalized with swine flu last spring, one in four ended up in intensive care and 7 percent of them died. In the Southern Hemisphere, 14 percent of flu patients in intensive care died.

Since Aug. 30, at least 936 Americans have died of flu symptoms or flu-associated pneumonia, and it appears H1N1 2009 flu will be at least as deadly as seasonal flu, which kills about 36,000 people annually.

Q: How is this flu season different from every other flu season?

A: The new flu strain is preying on children and young adults and appears to have a disproportionately high fatality rate in pregnant women. Older people, typically most vulnerable to flu, appear to have some immunity. Since April, 76 children have died of H1N1, including 19 last week, according to the federal Centers for Disease Control and Prevention. During the first four months of the outbreak, 100 pregnant women were hospitalized with the virus, and 28 died. The C.D.C. reports that 37 states now have widespread influenza activity, highly unusual this early in the season. Hospitalization rates for influenza also are higher than expected for this time of year.

Q: Since the vaccine for H1N1 is new, how do I know it is safe?

A: Every year, the seasonal flu vaccine is tailored to match the viruses circulating at the time, and the H1N1 vaccine was made exactly the same way.

Q: Was the H1N1 vaccine subjected to the same testing and clinical trials as seasonal flu vaccine?

A: The FDA does not require a new round of human clinical trials to study minor changes in the flu vaccine each year. However, clinical trials were conducted on the H1N1 2009 vaccine to determine the adequate dose. In addition, because H1N1 is a pandemic, we now have more information from other countries. Of the first 39,000 Chinese to get shots, only four had side effects, including muscle cramps and headaches. ?You could argue that this is better tested than seasonal flu vaccine,? said Dr. Paul A. Offit, chief of infectious diseases for Children?s Hospital of Philadelphia.

Q: Were manufacturing shortcuts taken to rush this vaccine to market?

A: Secretary of Health and Human Services Kathleen Sebelius has lauded the government?s quick response to the pandemic threat and the fast turnaround of the new vaccine. That has created perceptions that the vaccine was rushed. The reality is that in 2005, worries of a bird flu epidemic prompted the Bush administration to increase flu vaccine production capacity. It typically takes five to six months to make flu vaccine, and that is about how long it took to produce the H1N1 2009 vaccine. The H1N1 virus itself grows more efficiently than some past flu strains. ?We have cut no corners,? Dr. Thomas R. Frieden, the C.D.C. director, said at a news conference. ?This flu vaccine is made as flu vaccine is made each year, by the same companies, in the same production facilities with the same procedures, with the same safety safeguards.?

Q: How is flu vaccine made?

A: The C.D.C. identifies and tests a viral strain, then distributes a version of it to vaccine manufacturers, who inject it into millions of eggs, where it multiplies. Then the virus is harvested, purified and developed into a vaccine.

Q: What is the difference between the nasal spray and the flu shot?

A: The injectable vaccine or flu shot is made from a killed influenza virus that is highly purified and broken into tiny pieces. It cannot recombine in the body to produce flu, but it can still stimulate the immune system to evoke a protective response.

The nasal vaccine, called FluMist, is made of an attenuated live virus. This is a weakened version of the virus that has been tamed in the laboratory so it cannot cause illness. (The measles and chicken pox vaccines also are made from a live attenuated virus.) The attenuated virus can multiply only in the cooler temperatures of the nasal passages, and cannot survive in the higher temperatures of the respiratory tract, said Dr. William Schaffner, chairman of the department of preventive medicine at Vanderbilt University School of Medicine. When the vaccine is sprayed into the nose, it multiplies on the mucous membranes in the nose and throat, triggering the body?s immune response without causing any illness. Some studies suggest the nasal mist is more effective than the traditional flu shot.

FluMist is not approved for people with asthma, pregnant women or people with underlying medical problems like heart disease and diabetes.

Q: How long after vaccination does the body develop immunity to the H1N1 2009 virus?

A: In general, immunity to H1N1 2009 kicks in about seven to eight days after the vaccine, slightly faster than the 10 to 14 days typical of seasonal flu vaccine. However, a child below the age of 10 will need two doses of the H1N1 vaccine, spaced about a month apart, and full immunity will not occur until about a week after the final dose. ?Kids get two doses because they don?t develop as high of a protective antibody response from the first dose,? said Dr. Gregory A. Poland, an infectious disease specialist at the Mayo Clinic in Rochester, Minn.

Q: Can seasonal flu vaccine and H1N1 2009 vaccine be taken at the same time?

A: It depends on the formulation. A patient can receive two flu shots or a combination of nasal spray and flu shot. But patients who want both vaccines in nasal spray form must wait at least two weeks between vaccinations so the attenuated viruses do not compete against each other.

Q: If I?ve already had the flu this year, do I need either flu shot?

A: Unless your case was officially confirmed by a laboratory test as H1N1 2009, there is no way to be sure you are protected. If you did have confirmed H1N1, you are still vulnerable to seasonal flu.

Q: Can you get vaccinated against flu if you have a fever or a cold?

A: The flu vaccine is typically not recommended for patients with any signs of illness, so that symptoms are not wrongly misdiagnosed as side effects of a flu shot.

Q: Can people who are allergic to eggs get the flu vaccine?

A: The vaccine typically is not given to people with egg allergy. People at high risk for flu complications may be able to work with an allergist to be desensitized so they tolerate the vaccine.

Q: Why are pregnant women at higher risk of complications from H1N1 flu?

A: A woman?s immune system is compromised during pregnancy. Late in the pregnancy, the fetus pushes up against the thoracic cage and decreases a woman?s lung capacity, putting her at risk for respiratory complications if she contracts flu. A New England Journal study found that pregnant women with swine flu were nine times more likely to be in intensive care.

Q: Is flu vaccination an option for people with suppressed immune systems?

A: A flu vaccine works by stimulating the body?s immune system to produce antibodies against the virus. A person with a suppressed immune system cannot generate an immune response and does not benefit from vaccination. This includes many cancer patients undergoing chemotherapy, asthma patients who require large doses of steroids and those taking immune-suppressing drugs after an organ transplant. Patients who are immune-compromised should talk to their doctor about whether they should get a flu shot.

Q: Do adjuvants added to flu vaccine increase risk of an autoimmune reaction?

A: This is a myth perpetuated on some health web sites. Although substances called adjuvants are sometimes added to vaccines to make them more effective, no flu vaccine sold in the United States, including the H1N1 2009 vaccine, contains any adjuvants.

Q: Does the new vaccine contain the mercury compound thimerosal?

A: Flu vaccine packaged in a multidose vial contains thimerosal, a preservative that prevents contamination of the vial during repeated use. One dose from a multiuse vial contains about 25 micrograms of mercury. By comparison, a tuna fish sandwich contains about 28 micrograms of mercury. Repeated studies have shown thimerosal to be safe. However, people who want to minimize mercury exposure can ask for a vaccine in a single-dose package, which has only trace amounts. Thimerosal is not used in the production of FluMist.

Q: What about the severe complications associated with the 1976 swine flu vaccine?

A: A 1976 swine flu vaccine was associated with Guillain-Barr? syndrome (pronounced ghee-YAN bah-RAY), in which the body damages its own nerve cells, causing weakness and sometimes paralysis. The data on flu vaccine and Guillain-Barr? syndrome are not conclusive. One study suggested the 1976 vaccine posed a 1 in 100,000 risk. Another study found flu vaccine in general carries a 1 in one million risk for Guillain-Barr? syndrome. By comparison, 1 in 8,300 Americans dies of flu each year.

Q: If I think I have H1N1 2009, should I see a doctor?

A: Most people will recover without needing a doctor. High-risk patients should see a doctor at the onset of flu symptoms and may be treated with the antiviral drug Tamiflu.

 

[Retired]

You may find this attached release from the CDC informative,

Inactivated Influenza Vaccine, What You Need To Know