Archive for October, 2014

Head of GSK Ebola Vaccine Research: “Can We Even Consider Doing A Trial?”

Friday, October 31st, 2014 (last updated)

GlaxoSmithKline is considered by many a leading contender for delivering an Ebola vaccine at scale. Recent quotes by the Head of Ebola vaccine research for GSK, however, are sobering and indicate the enormous challenges ahead in the race to deliver a safe and effective vaccine in the quantities needed for the unprecedented outbreak in West Africa.

Ripley Ballou

“The thing that is going to have the biggest impact is what is happening to the trajectory of the epidemic curve. If you progress the current trends 2 months into the future are we still in an environment where you can even consider doing a trial?” Dr. Ripley Ballou, Head of Ebola Vaccine Research, GSK.

At the GSK vaccine research facility outside of Brussels, they are working to squeeze 10 years of trial activity into 12 months. The hope is to have 20,000 doses ready to be tested by health workers early next year.

“At the same time we have to be able to manufacture the vaccine at doses that would be consistent with general use, and that’s going to take well into 2016 to be able to do that. I don’t think this [vaccine] can be seen as the primary answer to this particular outbreak. If it does work then to be able to be prepared so that we don’t have to go through this again in five years, or whenever the next epidemic is going to break out.” Dr. Ripley Ballou.


The only right answers when it comes to vaccines

Thursday, October 30th, 2014 (last updated)

You’ve heard the anecdotes: Your friend’s toddler was doing great, just being a totally normal kid, and then all of a sudden he started showing signs of autism. Word has it that he had just gotten his vaccinations. You don’t like fear-mongering and you’re not a conspiracy-theorist, but isn’t this connection just a little too weird to be a coincidence? All you want is to do right by your kid — you want to ask the right questions and make the right decisions. But the whole issue of vaccinations ties your stomach in knots, and you feel neglectful no matter what you do.

I get it. Over the years, I have taken loads of my charges to get their vaccinations. I’ve talked to countless doctors on the subject. I have worked with many parents, and even those who understand the science behind vaccines and the overwhelming evidence supporting their safety have paused at the two-month visit, worrying about vaccine side effects — three pokes and an oral liquid for a baby? Can their system handle that? I am expecting a little baby of my own now, and what to do about her vaccinations will be one of my first parenting decisions.

I’ve seen the vaccination debate from many angles, and I think I can help clear some things up. Above all, I want to make it clear to those frightened parents that there’s nothing to be afraid of. Here are the most common concerns I hear, and some responses.

Hesitant parent: “But I saw a debate between both sides on the news — clearly this isn’t a simple issue.”

Actually, it is. Airing disagreements does not mean that both sides are legitimate, and between the commercial breaks, editing, and theatrics of television, it can be difficult to parse a substantive debate from an emotional one. Yes, there are emotions on both sides of this issue. But there is supporting evidence only on one. And the truth is that when it comes to many decisions, medical science isn’t always conclusive, but when it comes to vaccinations, it is. Vaccinations are life-saving. For user-friendly, evidence-based information, see the highly respected work of the vaccine education center at the Children’s Hospital of Philadelphia. You can also see how many children died or were hospitalized with these diseases before we had vaccines.

Hesitant parent: “Isn’t there scientific evidence linking the measles-mumps-rubella (MMR) vaccine to autism?”

No. There was an article in a reputable scientific journal, The Lancet, in the late-1990s, that linked the MMR vaccine to autism, but it was found to be fraudulent and later it was fully retracted. Many subsequent well done studies have found no link. Unfortunately, this false information has had lasting repercussions for many well-meaning parents.

Hesitant parent: “I’ve heard that it’s sensible to at least put my child on an alternative schedule for vaccinations, so that they’re not getting so many at once.”

I get that the alternative schedule seems like a win-win, but it’s not. What it means, first of all, is that kids aren’t getting their vaccines when they need them, and when the vaccines could protect them. It also means that parents get letters from their kids’ schools saying they cannot attend until their vaccinations are updated. Then the parents who had followed the alternative schedule guidelines from Robert Sears’ vaccine book frantically make appointments with their pediatricians to get caught up. I’ve seen schools require as many as 14 at once, and that is a lot. Even if the parent spaces them out at this point, that’s a lot of trips to the doctor, and pokes aren’t usually an appointment that the child is excited about.

Hesitant parent: “I’m just going to take a day off and read all of the studies I can possibly find, and then I’ll make a decision.”

That’s fine to do, but it also puts an awful lot of pressure on the parent. Of course parents have a role in the medical well-being of their child — they have intuition, and the benefit of knowing their child better than anyone else. But when it comes to vaccines, it’s about the details, and it’s easy for a novice to misinterpret them. Remember that medical professionals spend their careers learning how to read these studies and the data included in them. Why have we moved so far from simply finding a doctor we trust, and then trusting that doctor to do his or her job? We usually rely on experts to build our houses and fix our cars, and we don’t typically understand all of the in-and-outs — because life’s too short to be an expert on everything. But when it comes to vaccinations, relying on others is almost seen as lazy or irresponsible, instead of beautiful and even necessary. So I say take the pressure off. Don’t feel you need to be an expert. Instead, give yourself permission to let your doctor take the lead, provided — and this is crucial — it’s a doctor you trust.

It bears mentioning that as soon as my little bundle is in need of her vaccinations, she will get them. Because while many parenting decisions are complicated, this one isn’t. We needn’t fear vaccines, which have saved millions of lives. I love to evoke my countryman Oscar Wilde’s wisdom that “The only thing to do with good advice is to pass it on. It is never of any use to oneself.” So please, take my advice — vaccinate your children.


Where are we with Tuberculosis vaccine development

Wednesday, October 29th, 2014 (last updated)

Skeptical Meme Society

Next time someone tries to sell you something to cleanse “toxins” from your body, ask them what exact toxins they mean

Tuesday, October 28th, 2014 (last updated)

“Toxin” is a very broad and often misused term. If someone is trying to tell you anything about food, medicine or vaccine and can’t explain what specific “toxins” they are talking about, they are hopelessly unqualified to speak on the matter.


Skeptical Meme Society

A world without vaccines. Play the odds

Monday, October 27th, 2014 (last updated)

Ready to learn what your fate could’ve been? Just answer these 4 quick questions to find out whether you’d have made it to adulthood in a world without vaccines.

world without vaccines Click here

Save the Children

“Diseases don’t have passports”

Sunday, October 26th, 2014 (last updated)

Artist and father Daniel Arsham in support of vaccination.

Project Perpetual

Promising vaccination strategy to counteract RSV

Saturday, October 25th, 2014 (last updated)

Respiratory Syncytial Virus causes severe respiratory tract infections and worldwide claims the lives of 160,000 children each year. Scientists at VIB and Ghent University have succeeded in developing a promising vaccination strategy to counteract this common virus infection.

Xavier Saelens (VIB/UGent): “We discovered a new vaccination strategy that paves the way for the development of a novel approach to vaccination against RSV, a virus that causes suffering in numerous small children and elderly people.”

RSV: an infection that is difficult to combat

The Respiratory Syncytial Virus – abbreviated to RSV – is the most important cause globally of viral respiratory tract infections in young children. Children with a high risk of complications caused by RSV are sometimes treated preventively to avoid the infection, but this treatment is expensive and does not work therapeutically. Children with RSV infections are often hospitalized and primarily receive supportive care.
There is no medicine available yet that can effectively suppress an RSV infection. RSV infections are also common in the elderly and they can become severely ill as a result.

Searching for a RSV vaccine: prevention is better than cure

Previous attempts to develop a vaccine against RSV have failed miserably. A vaccine must prime our immune system so that it can protect us against a pathogen. The starting point in the development of a vaccine is usually the proteins that are present on the outside of the virus.

Many scientists and pharmaceutical companies are targeting the two large envelope proteins – F and G – in the development of a RSV vaccine, but these approaches are have yet to prove clinical benefit against disease caused by RSV.

Bert Schepens, Xavier Saelens and Walter Fiers (VIB/UGent) searched for an alternative strategy to attack the virus. They focused on a small, seemingly insignificant envelope protein of RSV, the so-called Small Hydrophobic protein (SHe). The immune system barely notices this viral protein during an infection with RSV. Therefore, the scientists linked the extracellular part of SH to another molecule. The resulting SHe conjugate did induce antibody production in laboratory animals.

New vaccine offers protection in lab animals

The SHe-specific antibodies do not  neutralize RS virus in vitro. However, mice that were vaccinated with the SHe vaccine were protected against a challenge with the virus. The growth of RSV in the lung tissue of the vaccinated animals was significantly reduced and the animals did not become ill. The experiments were repeated in cotton rats as these animals are naturally more sensitive to RSV infections

The positive results were confirmed: pretreatment with the SHe-vaccine suppressed the replication of RSV in the lung tissue of the infected cotton rats.

Surprising mechanism of action

As no neutralizing antibodies were induced, the vaccine must offer protection via a different mechanism. The scientists also unraveled this mechanism. The SHe-specific antibodies stimulate macrophages (cells that absorb foreign particles) in the respiratory tract to such an extent that they selectively ingest (phagocytose) the virus-infected cells

Bert Schepens (VIB/UGent): “This alternative approach to battle RSV has never been studied before and this is exactly the pathway that is triggered by the new candidate vaccine. The SHe-based vaccine could be linked to other candidate vaccines directed against the larger envelope proteins of the virus, to double hit the virus: with neutralizing antibodies in addition to antibodies that stimulate macrophages to selectively eliminate infected cells”.

News Medical Net

The psychological choice environment of vaccine decision making: two examples, one warning

Friday, October 24th, 2014 (last updated)

When Edward Jenner proposed to the parents of 8-year-old James Phipps the risky idea that rubbing some stuff from sick cows onto the young lad might protect him from small pox, James’ parents faced a choice. It was 1794 and smallpox was ravaging the British population, and in that emotional environment, the fear of smallpox won out over the frightening idea Jenner was proposing.

With no data or experience to go on, James’ parents could only rely on their emotions and instincts. Since then, we’ve learned an immense amount about vaccination, firmly establishing that the benefits of vaccines far outweigh their real but minimal risks. But those facts don’t change the reality that we consider whether to vaccinate in a psychological choice environment shaped far more by our feelings than the facts alone. The modern vaccination program offers two clarion examples of the emotional nature of our risk perception system, and how it can sometimes get us into trouble.

vaccine yes no

1. Childhood vaccination.

Despite lots of alarming news stories about declining childhood vaccination rates, in general those rates remain high. The vast majority of parents worry more about the diseases than the vaccines that prevent them, or trust their health care providers and just follow their advice. (A full list of rates per disease, per state, are in this CDC chart.)

But small groups in some local areas either refuse to vaccinate their children at all (less than 1 percent of children overall in the U.S.) or choose not to vaccinate or to delay vaccination against some diseases. For example, in 17 states, local pockets of vaccine hesitancy have dropped the statewide average rates for measles/mumps/rubella below the 90 percent target.

The facts about the risks of diseases and vaccines are the same for the tiny group of vaccine refusers or the slightly larger group of those hesitant about the recommended schedule as they are for the general public. But the psychological choice environment in which the “refusers/hesitants” are making vaccine decisions is different. Some of those people don’t like the government telling them what to do. Some have particularly high fears of human-made risks, like vaccines. Some live in communities that place high priority on micro-level decision making about parenting. These different emotional risk perception factors lead them to worry more about the vaccines than the diseases, or mistrust the public health system that recommends vaccines, or the pharmaceutical industry that produces them.

As a result of those emotional differences, these people expose their kids and themselves and the public to far greater risk than the minimal danger of vaccines. But these choices are neither irrational, nor “science denialism,” as some academics and doctors and pundits dismissively label them. These choices are based on people’s legitimate and valid feelings. These choices are based on people’s legitimate and valid feelings, emotions and instincts we all we all use to assess the facts and gauge potential risk. The feelings and values and life experiences and circumstances of the refusers and hesitants just lead them to see the same facts about vaccines through different emotional lenses than most people do.

However, valid as those feelings may be, it is undeniable that they put those people, and their kids, and their friends and neighbors and communities, at risk.

2. Seasonal influenza vaccine

Childhood vaccination is getting most of the attention from the news media that now raises alarms about declining vaccination rates but just a few years ago was full of scary stories about the risks of vaccines, helping trigger the very decline about which they are now raising concern. But another form of vaccination offers a lesson about the potential danger of our emotion-based risk perception system; the regular vaccination for seasonal flu, which is now recommended for everyone 6 months old and up.

Childhood vaccination rates in the U.S. are above 90 percent. But in a good season, vaccination rates for seasonal flu hover around 40 percent for adults and 50 percent for children. According to the CDC, influenza kills 1,532 Americans a year directly, and contributes to the deaths of between 3,000 and 49,000. The number of people unvaccinated against the flu dwarfs the number of un- or partially-vaccinated kids. And the numbers of people who get sick or die from influenza, many of whom are young children with still-developing immune systems, dwarfs the number of people who get sick or die because childhood vaccination rates run low in some areas. Between the two, the low vaccination rates for influenza pose a far greater threat to public health in terms of illness and death. Talk about “irrational!”

But the psychological choice environment for whether to get a flu shot is different than the factors influencing concerns about childhood vaccination. When risks to kids are involved, fears almost always run higher. But flu is familiar, and familiarity with any risk reduces concern. The flu shot is always available, so we think that we can always go get one… a reassuring sense of control that seduces some of us into not worrying enough to get the shot in the first place.

We worry more about new UNfamiliar flu, or when there might be vaccine shortages and we lose that sense of control. But in normal times, far fewer of us get flu shots than should. And unless you’ve had a bad case of influenza, you’re like most people; you don’t think getting it is that bad… and when we don’t sense a lot of suffering from a risk, we don’t worry about it as much. (Trust me on this one. You REALLY SUFFER, for weeks or more, when you get a bad case of influenza, as millions do each year.)

Two vaccine issues. Two different sets of numbers, two different sets of emotional factors that cause some of us worry more than we need to, or less than we should. But together, these examples illustrate a single phenomenon; the Risk Perception Gap, the risk we face when our fears don’t match the facts. These examples help make the case that we need to recognize how powerfully the psychological choice environment shapes our judgments and behaviors, and account for those emotional factors as we try to make healthier choices for ourselves and for society.


The vaccine fight becomes a slow trench war

Thursday, October 23rd, 2014 (last updated)

Like any trench war, the fight to protect America’s kids against disease is proceeding only inch by inch. A new report shows why there’s reason for hope—and reason for worry

It’s just as well that no one knows the names of the 17,253 sets of parents in California who have opted not to have their children vaccinated, citing “philosophic” reasons for declining the shots. The same is true of the anonymous 3,097 in Colorado who have made the same choice—giving their far smaller state the dubious distinction of being dead last among the 50 states and the District of Columbia in the simple business of protecting their children against disease.

On the other hand, kudos to you, Mississippi, for finishing number one—with an overall kindergartener vaccination rate in the past school year of 99.7%—and to you, Louisiana, Texas and Utah, for finishing not far behind. Your children, by this measure at least, are the safest and healthiest in the country.

These and other findings were part of the alternately reassuring and deeply disturbing survey from the CDC’s Morbidity and Mortality Weekly Report (MMWR), looking at vaccination coverage for more than 4.25 million kindergarteners and the opt-out rates for more than 3.9 million in the 2013-2014 school year

The report’s top line number seems encouraging. The national compliance rate for the three major vaccines covered in the survey ranged from 93.3% (for chicken pox) to 94.7% (measles, mumps, rubella, or MMR) to 95% (diptheria, tetanus, pertussis).

But even those numbers don’t mean America has aced the test. Vaccination rates need to reach or exceed 95%, depending on the disease, to maintain herd immunity—the protection afforded by vaccinated people to those few who can’t be vaccinated, by giving the virus too few ways to body-surf its way across a population until it finds someone who’s vulnerable. So while a 90% vaccination rate might look like an A, it in fact may be no better than a middling C.

And in some parts of the country, the numbers are much, much worse. As I reported in TIME’s Oct. 6 issue, vaccination refusal tends to be a phenomenon of the wealthier, better educated, politically bluer parts of the country—the northeast, the Pacific coast and pockets around major universities. Those are communities in which folks know just enough to convince themselves that they know it all—which means they know better than the doctors, scientists and other members of medical community at large, who have overwhelmingly shown that vaccines are safe and effective.

That’s part of the reason New York City’s elite private schools have vaccination rates far lower than the city’s public schools, and why, according to a shocking story by the Hollywood Reporter, some schools in the wealthier neighborhoods of Los Angeles have a lower vaccination rate than in South Sudan.

don't wait... vaccinate


Pneumococcal vaccine reduces antibiotic-resistant infections by 62%

Wednesday, October 22nd, 2014 (last updated)

Previous studies have concluded that overall vaccination reduces the risk of non-targeted infections among vaccinated individuals. Now new research presented at IDWeek 2014 suggest that the pneumococcal vaccine dramatically reduces severe antibiotic-resistant infections by as much as 62 percent among children.

IDWeek 2014

Pneumococcal disease is a bacterial infection that causes sepsis, pneumonia, and meningitis as well as hearing loss, vision loss, and death. The infection is also the most common vaccine-preventable bacterial cause of death. The pneumococcal vaccine (PCV) should be administered at 2 months, 4 months, 6 months, and between 12 and 15 months as well as to children and teenagers in high-risk groups between 2 and 18 years old.

Explained lead researcher Sara Tomczyk, PHN, MSc, epidemic intelligence service (EIS) officer for the Respiratory Diseases Branch, Centers for Disease Control and Prevention (CDC), Atlanta: “Pneumococcal infections can cause several clinical syndromes, including ear infection, pneumonia, and more serious infections such as meningitis and blood infections. Last year antibiotic resistance due to pneumococcal infections was deemed a serious threat in a large CDC report. It was estimated that it leads to more than 19,000 excess hospitalizations, 7,000 excess deaths, and $96 million in excess medical costs per year.”

The current pneumococcal vaccine, the 13-valent pneumococcal conjugate vaccine (PCV13, Prevnar 13), induces immune protection against thirteen subtypes of Streptococcus pneumoniae, the bacterium that causes pneumonia, meningitis, blood infections, ear infections, and other health problems. PCV13 replaced the previous 7-valent version, which protected against fewer subtypes, in 2010.

Use of the 13-valent pneumococcal vaccine subsequently reduced the rate of antibiotic-resistant invasive pneumococcal disease by 62 percent between 2009 to 2013 among children under the age of 5, a decrease of nearly two-thirds.

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