Vaccines 4/09-10/09

Vaccine. 2009 Oct 3.

Small fiber neuropathy following vaccination for rabies, varicella or Lyme disease.

Souayah N, et al.

Department of Neurology, New Jersey Medical School, Newark, NJ

Neuropathy following vaccination has been reported; however, biopsy-confirmed small fiber neuropathy has not been described. We report five patients who developed paresthesias within one day to two months following vaccination for rabies, varicella zoster, or Lyme disease. On examination, there was mild sensory loss in distal extremities, preserved strength, normal or minimally abnormal electrodiagnostic findings, and decreased epidermal nerve fiber densities per skin biopsy. Empiric immunomodulatory therapy was tried in two patients and was ineffective. All patients' symptoms have improved, but persist. We conclude that an acute or subacute, post-vaccination small fiber neuropathy may occur and follow a chronic course.

Looking forward to reading the whole paper. But from the abstract, it doesn’t sound like a common adverse event. They found only five patients. Rabies vaccine shouldn’t be much of a concern since it’s seldom used and then only in life-or-death situations. The Lyme vaccine went off market years ago. The only concern then is varicella, which all children receive, and which many aging adults may get boosted against to prevent recurrent shingles.-

From Medical News:Study reveals that most Americans will refuse FDA authorized emergency use H1N1 flu vaccine According to a University of Pittsburgh Graduate School of Public Health and University of Georgia study fewer than 10 percent of people surveyed said they would be willing to take such a vaccine or drug and nearly 30 percent remained undecided. [snip]

Several drug additives, or adjuvants - sometimes added to vaccines to strengthen the immune response and stretch the quantity of available vaccines in the event of a pandemic - have been ordered and stockpiled by the federal government in case they may be needed. But adding them to H1N1 vaccines would trigger an EUA, which is one of the reasons the federal government has chosen not to use them.

The study was based on a survey that focused on attitudes toward H1N1 and willingness to accept flu vaccines and drugs not officially approved by the FDA, but authorized for emergency use. Of the 1,543 adults questioned in June 2009, 46 percent of people surveyed said they were concerned about getting swine flu. However, nearly 86 percent said they thought it was unlikely or very unlikely that they themselves would become ill.

'Communication about the H1N1 vaccine is enormously challenging,' said study author Sandra Quinn, Ph.D., of the University of Pittsburgh Graduate School of Public Health.

In the event an emergency-use adjuvant is required to stem the H1N1 pandemic, public health professionals will need to articulate a strong case for the vaccine and aggressively address myths and misinformation to increase understanding and acceptance.

It was the second wave that really hurt in 1918-19.

Boston Globe: Second wave of swine flu pandemic begins to hit US

By Rob Stein, Washington Post, September 28, 2009

WASHINGTON - After months of warnings and frantic preparations, the second wave of the swine flu pandemic is starting to be felt around the country. Doctors, health clinics, hospitals, and schools are reporting rapidly increasing numbers of patients experiencing flu symptoms.

[snip]

The government is starting an unprecedented system to track possible side effects as mass flu vaccinations begin next month. The idea is to detect any rare but real problems quickly, and explain the inevitable coincidences that are sure to cause some false alarms.

In just a few months, health authorities hope to vaccinate well over half the population against swine flu, which doctors call the 2009H1N1 strain. No more than 100 million Americans usually get vaccinated against regular winter flu, and never in such a short period.

The last mass inoculations against a different swine flu, in 1976, were marred by reports of a rare paralyzing condition, Guillain-Barré syndrome, a sometimes fatal paralysis. Other possible side effects could potentially include heart attacks, strokes, seizures, and miscarriages.

On top of routine vaccine tracking, these government-sponsored monitoring projects are planned:

Harvard Medical School scientists are linking large insurance databases that cover up to 50 million people with vaccination registries around the country for real-time checks of whether people see a doctor in the weeks after a flu shot and why. The huge numbers make it possible to quickly compare rates of complaints among the vaccinated and unvaccinated, said the project leader, Dr. Richard Platt, Harvard’s population medicine chief.

Johns Hopkins University will direct e-mails to at least 100,000 vaccine recipients to track how they’re feeling, including the smaller complaints that wouldn’t prompt a doctor visit. If anything seems connected, researchers can call to follow up with detailed questions.

The Centers for Disease Control and Prevention is preparing take-home cards that tell vaccine recipients how to report any suspected side effects to the nation’s Vaccine Adverse Event Reporting system.

“Every day, bad things happen to people. When you vaccinate a lot of people in a short period of time, some of those things are going to happen to some people by chance alone,’’ said Dr. Daniel Salmon, a vaccine safety specialist at the Department of Health and Human Services.

But how many will really understand what “chance” means? “Chance and Necessity”—to borrow a phrase and a title—are not concepts the public, the press or the politicians easily grasp.

More about all this from today’s NYT.

The government “is right to expect coincident deaths, since people are dying every day, with or without flu shots,” said Dr. Harvey V. Fineberg, president of the Institute of Medicine and co-author of “The Epidemic That Never Was,” a history of the 1976 swine flu vaccination campaign.

[snip]

In the opening days of the 1976 vaccination campaign, which eventually vaccinated 45 million Americans, three elderly Pittsburgh residents died soon after receiving their shots at the same clinic. Though scientists believe it was just a freakish coincidence, some news reports suggested the vaccine had killed them.

“Press frenzy was so intense it drew a televised rebuke from Walter Cronkite for sensationalizing coincidental happenings,” Dr. David J. Sencer, who was then the director of the C.D.C., wrote in 2006 reflections on the vaccination campaign.

[snip]

Other changes since 1976 worry officials. The 24-hour cycle of news on television and the Internet did not then exist; public health officials now must be ready to respond to rumors instantly. In 1976, the C.D.C. did not hold news conferences, and it took it five days to respond to the Pittsburgh deaths, Dr. Fineberg said.

[snip]

Complicating the challenge for officials, some experts argue, is that health news coverage has suffered since 1976.

“I’ve seen the rise and fall of experienced medical reporters,” said Dr. Michael T. Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. “I can’t tell you how many reporters have come to me since last spring who don’t really know what flu is.”

Also, antivaccine activists are far more powerful now. Thirty-three years ago, vaccines were enthusiastically welcomed; many parents or grandparents still remembered children dead of smallpox, measles or polio. The minority opposing them were often followers of natural healing or traditional chiropractic beliefs.

[snip]

And, in the rancor over health insurance reform, unfounded rumors are spreading that the Obama administration will make swine flu shots mandatory. Administration officials have emphatically denied that. But a recent decision by New York State to make them mandatory for all hospital employees has reinvigorated those rumors on the Internet.

To defend itself, Dr. Butler said, the C.D.C, has compiled data on how many problems like heart attacks, strokes, miscarriages, seizures and sudden infant deaths normally occur. And it has broken those figures down for various high-priority vaccine groups, like pregnant women or children with asthma. When vaccinations begin, it plans to gather reports from vaccine providers, hospitals and doctors, looking for signs of adverse events, so it can detect problems before rumors grow.

“Then we’ll try to verify the signal, see if it’s real,” Dr. Butler said. “Then we’ll try to see if it’s associated with the vaccine. If it is, we’ll say so. The process will be as transparent as we can make it.”

It won’t matter.

-

The other half are waiting to faint on cue.

By Daniel J. DeNoon

WebMD Health News

Sept. 23, 2009 - Half of American adults say they'll get the new H1N1 swine flu vaccine, a RAND survey shows.

The Internet-based survey of a nationally representative panel of 2,067 U.S. adults took place in early June.

At that time, 49.6% of those surveyed said they were likely to get the H1N1 swine flu vaccine. If they do, it means nearly 115 million U.S. adults will seek the vaccine when it becomes available.

[snip]

But does that mean the cup is half full or half empty? The survey suggests that more than half of Americans will not want a shot -- even if there's plenty of vaccine to go around.

"Our findings ... caution against taking high uptake rates for a potential novel H1N1 vaccine for granted," Maurer and colleagues warn. "Achieving high rates of uptake of novel H1N1 vaccine will likely require a very aggressive and culturally appropriate public information campaign and strong recommendations from health care providers."

Such a campaign may not help. In fact, it could reduce overall vaccine coverage by increasing the number of complains about alleged vaccine adverse events by members of anti-vaccine and anti-science groups, and by people who are susceptible to the nocebo effect.

From New Scientist magazine:

“Though the mechanism remains a mystery, but at least now this kind of phenomenon has a name. The "nocebo effect" is the lesser-known opposite number of the placebo effect, and describes any case where putting someone in a negative frame of mind has an adverse effect on their health or well-being. Tell people a medical procedure will be extremely painful, for example, and they will experience more pain than if you had kept the bad news to yourself. Similarly, experiences of side effects within the placebo groups of drug trials have shown that a doctor's warning about the possible side effects of a medicine makes it much more likely that the patient will report experiencing those effects.”

More about the nocebo effect:

Issues about the nocebo phenomena in clinics.

The placebo, which in Latin means “I shall please”, has received more and more attention from clinical researchers; while its flip side nocebo, which in Latin means “I shall harm”, still lacks the recognition it deserves.

The nocebo effects are usually presented by the subjective symptoms; for example: nausea, headache, drowsiness, etc. But objective symptoms like heart rate, blood pressure and skin rash can also be used to indicate nocebo effects. These symptoms could be temporary and mild, but also could be chronic and deadly. Similar to the placebo effect, the nocebo effect could be significant, too. In the same trial, 80% of hospitalized patients, given sugar water and told that it was an emetic, subsequently vomited. An extreme example of nocebo effect is described as “voodoo death”, the person who was cursed by a local witch doctor and died several days later of no obvious organic cause. The cursed one dies because of fear, nervousness and some other negative expectations.

More and more attention has been paid to the nocebo effect, since it was first proposed in 1961. There have been a total of 99 papers recorded in PubMed from 1961 to February 19th, 2009, using “nocebo” as the keyword for the search; 72 of these were published after 2000, and only 10 before 1990.

FACTORS INFLUENCING THE NOCEBO EFFECT

Negative expectations

Patients who have doubts about their treatments have more chance to suffer the nocebo response.

History of adverse reaction

A study held in 3 cities in Italy indicates that 162 patients (27%) out of 600 outpatients with exact past experience of adverse drug reaction developed side-effects. The major symptoms occurred were subjective: itching, dizziness, discomfort etc. Objective symptoms, such as tachycardia, cough or skin lesions, only happened in 50 patients.

Gender

Females more frequently have nocebo responses.

Personality

Although empirical evidence is lacking, depressed patients also seem to be particularly prone to medication side effects.

Age

Elderly people are more likely to experience nocebo effect.

Psychological factor

Moreover, the public's attitudes towards drugs also play an important role in the occurrence of nocebo phenomena, even if these attitudes may not be true. Take penicillin for example, people always believe that it is an easily allergic drug, and in clinical practice, approximately 10% patients would be allergic to it. However, one study including 132 patients who had been classified as allergic to penicillin found that only 4 (3%) were actually allergic.

Social influence

When a person in a certain population has terrible symptoms, the rest may observe, realize and even be affected by this situation. Thus, these symptoms prevail over the whole population, namely “mass hysteria” in population.

I suppose it may be possible to blame the Internet—or at least some of its users—for creating a kind of “virtual hysteria” through online POSTINGS about alleged medicinal or vaccination side effects, opinion disguised as fact, misinformation, deliberate disinformation, conspiracy theories, and all-around fear-mongering. The Internet’s information is only as reliable as the expertise and honesty of its authors, and any resulting Internet-based nocebo effect is going to be proportional to the intelligence of its readers.

In a word, modern public health faces an insurmountable communications problem.

Pulling for a one-dose vaccineFrom Revere’s Effect MeasurePosted on: September 19, 2009

It's a virus that kills someone every 20 minutes in this world, usually a child. A vaccine is on the way but isn't here yet. The good news is that what usually requires multiple doses may only require a single dose. It's big news. It's also not about swine flu vaccine:

A replication-deficient rabies virus vaccine that lacks a key gene called the matrix (M) gene induced a rapid and efficient anti-rabies immune response in mice and non-human primates, according to James McGettigan, Ph.D., assistant professor of Microbiology and Immunology at Jefferson Medical College of Thomas Jefferson University.

"The M gene is one of the central genes of the rabies virus, and its absence inhibits the virus from completing its life cycle," Dr. McGettigan said. "The virus in the vaccine infects cells and induces an immune response, but the virus is deficient in spreading."

The immune response induced with this process is so substantial that only one inoculation may be sufficient enough, according to Dr. McGettigan. In addition, the vaccine appears to be efficient in both pre-exposure and post-exposure settings.

[snip]

Once bitten by a rabid or potentially rabid animal there is about a month to get a series of rabies shots. In the US it's a series of six shots, five with vaccine and one with rabies immunoglobulin. The standard vaccine is inactivated virus, but the new vaccine removes the M gene and is a live virus. Presumably that's why it is so immunogenic.

[Note: One night in Massachusetts, a friend of mine stepped out into his garage. He startled a raccoon and it bit him. That minor bite necessitated a trip to the ER, 5 shots of vaccine, some gamma globulin, a tetanus shot and antibiotics. Now he turns the light on before he steps into the garage.]

Who knew they all shared so much common ground. But I suppose no one group has a monopoly on ignorance, conspiracy theories and anti-science beliefs.

First the Taliban…

Polio, a legacy of the Taliban

September 15, 2009

Scripps Howard News Service

Here’s another reason not to let the Taliban take over Afghanistan or any other country for that matter.

In a spectacularly misguided effort at bringing peace to the Swat Valley Pakistan’s central government let the Taliban take over and install their own harsh and extreme version of Islamic rule, causing 2 million people to flee what had once been a prosperous resort area.

One of the Taliban’s more bizarre and cruel acts was to outlaw polio vaccinations on the grounds that they were both un-Islamic and a Western plot to sterilize Muslim children.

Now that the Pakistani army has retaken the region and restored a semblance of normality, the government has set out to immunize some 215,000 children.

[snip]

The people of the Swat Valley want the vaccinations for their children, and it is to be hoped Pakistani public health officials get to them in time.

And on the Christian Right we have….

Teen Rejects Vaccine on Moral Grounds; Denied Citizenship

By Jennifer Riley

Christian Post Reporter

Sep. 15 2009

Time is running out for a British teen seeking U.S. citizenship after she refused to be injected with a vaccine that protects against a sexually transmitted virus linked to cervical cancer.

Simone Davis, who turns 18 next January, turned down the vaccine Gardasil because she says she is not sexually active and believes the vaccine comes with the risk of adverse health effects.

“I am only 17 years old and planning to go to college and not have sex anytime soon,” Simone, a devout Christian who believes the Bible prohibits premarital sex, told ABC News. “There is no chance of getting cervical cancer, so there’s no point in getting the shot.” U.S. law, however, requires immigrants seeking to become U.S. citizens to receive a list of vaccinations, Gardasil being among them.

[snip]

Apparently, she’s afraid of alleged adverse events (I don’t recall my daughter complaining of any), but not of cancer. Frankly, it’s cheaper to take the shot than to pay for cancer treatments, which may ultimately cost one’s life. As for the Bible prohibiting premarital sex, she had better study the Not-So-Good Book a little more closely. I seem to recall quite a lot of polygamy, rape, incest, prostitution, extracurricular fornication, etc.

On to the anti-vaccine, anti-science, conspiracy groups…..

Vaccine skepticism is in the air; With the healthcare debate storming on, a study on attitudes over the flu vaccine shows a clear distrust in government. For some, such as blacks and immigrants, suspicions have deep roots.

By Melissa Healy

The LA Times

September 14, 2009

[snip]

Vaccine refusers have long decried vaccine mandates and campaigns as an unwarranted intrusion of parents' and local school boards' rights. And against the backdrop of charges that a "public healthcare option" would hijack patients' choices, such complaints have taken on new resonance for some.

[snip]

And for a new generation of vaccine skeptics, there are new objects of distrust. For some, it lows from a suspicion of the multinational corporations that develop and manufacture vaccines. For others, it comes from a belief that media outlets have hyped the pandemic flu story to secure the attention of readers and the revenue of advertisers. And many simply doubt the competency and independence of government agencies, which they believe are too inept, overwhelmed or co-opted by corporate interests to secure the safety of the nation's drugs and food supply.

[snip]

This is largely why there are only two vaccine manufacturers left in the U.S. Frankly, I’m surprised there are that many. It’s an expensive, thankless, low-profit task making the dozen vaccines that ended polio, smallpox, diphtheria, tetanus, hepatitis, measles, rabies, etc.

It’s hard to protect people from themselves. I guess that’s why there are so many daily victims of financial scams and quack medical treatments. How do you explain to people the benefits of routine vaccination who have no knowledge of medicine or science, have never seen a case of measles or polio, and have little sense of the impact of vaccines on history?

It’s the marriage of ignorance and arrogance all over again.

v

Buzz Aldrin, sick of the conspiracy nuts who kept insisting his walk on the moon was faked, finally hauled off and punched one of these poor fools in the face. No doubt it was more effective—not to mention satisfying—than any reasoned argument could have been. Such people simply are beyond the reach of reason.

Likewise the Lyme conspiracy nuts who think a common bacterial infection is the work of some vast government-insurance plot.

Apparently, many of them are convinced the Infectious Diseases Society of America is “suppressing” information showing that “chronic Lyme disease” is actually a persistent infection, and not mere post-infection damage, inflammation, autoimmunity, etc. The activists seem to believe that a Lyme vaccine will activate their latent and persistent B. burgdorferi infections, thereby making it dangerous to use in Lyme-endemic areas. Further, their irrational thinking leads them to conclude that many people in the IDSA are involved in vaccine research and would lose a great deal of money if the possibility of persistent infection is made known. Consequently, they are suppressing any evidence of persistent infection. That’s why it’s not mentioned in the IDSA treatment guidelines for Lyme disease. Moreover, they are blocking the development of new diagnostic tests that might reveal persistent infection.

I’m not going to pick through this nonsense line by line; it would be like picking through week-old garbage with your bare hands. Suffice to say; the IDSA comes off sounding like that secret society Homer Simpson belonged to: the pervasive, persistent, all powerful Stone Cutters manipulating currencies, hiding Martians, electing presidents. Hell, if the IDSA can do pretty much the same things maybe I should just pay the annual dues and join. I wonder if they have cool (but secret) tattoos?

Buzz is probably too busy to stop by and punch out these nuts. Too bad, because the fluoride and other mind-control substances in the national water supplies don’t seem to be working very well.

Final thought: what if the IDSA really is working on vaccines? Maybe therapeutic vaccines?

URI wins $13-million federal grant for vaccine research

Wednesday, July 29, 2009

By C. Eugene Emery Jr.

PROVIDENCE — Dr. Annie De Groot and her colleagues think they have a better way of speeding the development of vaccines against Lyme disease, hepatitis and stomach cancer.

The federal government apparently believes their ideas are worth a $13-million investment.

The University of Rhode Island, where De Groot works, announced Tuesday it will receive a five-year grant from the National Institutes of Health to throw new resources at De Groot’s vision of using computer software to design lean, mean, more potent vaccines, and then use a faster process for testing their effectiveness in humans.

[snip]

At URI’s main campus in South Kingstown, Thomas Mather will be trying to fine-tune a vaccine that will protect people against Lyme disease and other tick-transmitted illnesses, not by directly vaccinating them against those diseases but by sensitizing the immune system to attack tick saliva.

The hope is that if the body can be sensitized to tick saliva, it will block the nasty bugs that come with it.

That’s one reason why guinea pigs don’t get Lyme disease, De Groot said.

[snip]

-

Arthritis Rheum. 2009 Mar 30;60(4):1179-1186.

HLA type and immune response to Borrelia burgdorferi outer surface protein a in people in whom arthritis developed after Lyme disease vaccination.

Ball R, Shadomy SV, Meyer A, Huber BT, Leffell MS, Zachary A, Belotto M, Hilton E, Bryant-Genevier M, Schriefer ME, Miller FW, Braun MM.

Center for Biologics Evaluation and Research, FDA, Rockville, Maryland.

OBJECTIVE: To investigate whether persons with treatment-resistant Lyme arthritis-associated HLA alleles might develop arthritis as a result of an autoimmune reaction triggered by Borrelia burgdorferi outer surface protein A (OspA), the Lyme disease vaccine antigen.

METHODS: Persons in whom inflammatory arthritis had developed after Lyme disease vaccine (cases) were compared with 3 control groups: 1) inflammatory arthritis but not Lyme disease vaccine (arthritis controls), 2) Lyme disease vaccine but not inflammatory arthritis (vaccine controls), and 3) neither Lyme disease vaccine nor inflammatory arthritis (normal controls). HLA-DRB1 allele typing, Western blotting for Lyme antigen, and T cell reactivity testing were performed.

RESULTS: Twenty-seven cases were matched with 162 controls (54 in each control group). Odds ratios (ORs) for the presence of 1 or 2 treatment-resistant Lyme arthritis alleles were 0.8 (95% confidence interval [95% CI] 0.3-2.1), 1.6 (95% CI 0.5-4.4), and 1.75 (95% CI 0.6-5.3) in cases versus arthritis controls, vaccine controls, and normal controls, respectively. There were no significant differences in the frequency of DRB1 alleles. T cell response to OspA was similar between cases and vaccine controls, as measured using the stimulation index (OR 1.6 [95% CI 0.5-5.1]) or change in uptake of tritiated thymidine (counts per minute) (OR 0.7 [95% CI 0.2-2.3]), but cases were less likely to have IgG antibodies to OspA (OR 0.3 [95% CI 0.1-0.8]). Cases were sampled closer to the time of vaccination (median 3.59 years versus 5.48 years), and fewer cases had received 3 doses of vaccine (37% versus 93%).

CONCLUSION: Treatment-resistant Lyme arthritis alleles were not found more commonly in persons who developed arthritis after Lyme disease vaccination, and immune responses to OspA were not significantly more common in arthritis cases. These results suggest that Lyme disease vaccine is not a major factor in the development of arthritis in these cases.

See the FDA/VAERS data on Lymerix from January 31, 2001.