Pregnant women in the UK to be offered whooping cough vaccination

The British Department of Health announced last week, that starting from today, pregnant women will be offered the whooping cough vaccine to protect their new borns. The idea is that when vaccinated during pregnancy, the maternal antibodies will be passed through the placenta to the baby before birth and will protect the infant in the first couple of months of their lives, when they cannot yet be vaccinated. This move comes after nine infants, all under three months old, died of pertussis in the UK of 302 under 3 month olds who contracted the disease (yes, that is a mortality of 3 percent, 3 of 100). The HPA welcomes this move, after having received notification of 1230 whooping cough cases in August 2012 alone.

Whooping cough is not a mild disease by any stretch of the imagination - the BBC has several testimonials from mothers of babies, but also older kids:

Nine year old Zara Mummery was seven when she caught whooping cough. One night she was coughing so much she stopped breathing.

"It was very frightening, but I remember that my mum brought me into the bathroom and she called the paramedics.

"She was just screaming on the phone 'my child's going to be dead, please come'."

Her mother Katrina said she couldn't get her daughter to breathe.

"It was like she froze. It was one of the most terrifying things any parent can go through, to think they have lost a child."

Zara spent a week in hospital on very strong antibiotics and is now fit and well.

 While the number of cases in the UK are increasing at an alarming rate,

it is worth remembering what the situation was like before the introduction of the vaccine. 

Before routine vaccination in 1957, whooping cough outbreaks in the UK were on a huge scale. It could affect up to 150,000 people and kill 300 in a single year.

What is already being remarked in vaccine-critical circles is that the dTaP/IPV booster vaccine, Repevax, is not recommended for use in pregnant women in the UK. The package information states:

Pregnancy

The effect of REPEVAX on embryo-foetal development has not been assessed. No teratogenic effect of vaccines containing diphtheria or tetanus toxoids, or inactivated poliovirus has been observed following use in pregnant women. Limited post-marketing information is available on the safety of administering REPEVAX to pregnant women.

In their FAQs for GPs, the reason for the recommendation despite this disclaimer is provided:

Why does the Patient Information Leaflet state that Repevax® should not be used in pregnancy?

This says that the vaccine is not recommended for use in pregnancy because of the routine exclusion of pregnant women from clinical trials, and not because of any specific safety concerns or evidence of harm in pregnancy. Use in pregnancy is not contraindicated.

The CDC recently published the reasoning behind their older recommendation to vaccinate pregnant women against pertussis, and, using data from VAERS and two smaller studies, found that vaccination during pregnancy is safe. There is good indication that vaccine-induced antibodies pass through the placenta and hence would protect the newborn.

This new recommendation could save lives - I'll tell my pregnant friends about it - you should, too.

Non-Medical Vaccine Exemptions: Balancing Parental Rights and Public Health

U.S. Religious and Philosophical Vaccine Exemptions 

Philosophical and religious vaccine exemptions have been a hot topic lately with California's AB 2109 Bill which would require parents who wish to opt out of vaccination obtain an approved healthcare providers' signature that the parents have been advised of the risks of not vaccinating.  And Washington State's recent passing of the same type of bill has anti-vaxx groups in a collective apoplexy.  New Jersey is also discussing tightening their religious exemptions and a new bill S1759 has been submitted to the state Senate for a vote.  New Jersey has no philosophical exemption so its religious exemption has been easily used for parents to opt out of vaccines.

I like others have a problem with just religious exemptions for the reason that there are no recognised religious organisations that oppose vaccines and they also exclude secular beliefs.  In fact, there is no constitutional right or protection requiring religious exemptions to be provided.  There are no constitutional protections from compulsory vaccination for philosophical reasons either in spite of vapid assertions to the contrary.

An Equal Protection challenge to vaccination regulations was denied in Zucht v. King as the U.S. Supreme Court ruled that vaccination laws do not discriminate against schoolchildren to the exclusion of others similarly situated (i.e., children not enrolled in school). (221)  In the case of Adams v. Milwaukee, Justice Brandeis reaffirmed Jacobson's holding that states may delegate the power to order vaccinations to local municipalities, and that broad discretion must be granted in the application and enforcement of the resulting public health regulations. (222)  In Prince v. Massachusetts, the Supreme Court held that the First Amendment's Free Exercise Clause does not allow for the right to expose the community or one's children to harm from disease. (223)  An Arkansas court later affirmed that school vaccination requirements do not deprive individuals of liberty and property interests without due process of the law. (224) Moreover, even where a parent objects to compulsory vaccination, a child does not have an absolute right to enter school to receive an education. (225)  Clearly then, the rights of individuals to be free from unwanted government interference in the form of compulsory vaccinations have been severely limited by the courts where public health is at stake.

But what about the constitutionality of compulsory vaccinations where no exemptions at all are provided--i.e., neither for philosophical nor religious reasons?  Again, the judiciary has held that individual rights may be restricted in the name of the public welfare without violating the Constitution.

States that do offer religious exemptions place themselves in a more precarious position legally.

Some state courts have held that parents must be members of a "nationally recognized and established church or religious denomination" in order to claim an exemption, (229) but others have found that similar regulations violate the Equal Protection Clause of the Constitution by giving preference to certain religions over other. (230)  Moreover, some courts have gone as far as to say that providing any religious exemption violates the Equal Protection Clause because it "discriminate[s] against the great majority of children whose parents have no such religious convictions." (231)

As it stands now, 48 U.S. states allow religious exemptions and 20 allow philosophical exemptions.   Some retrospective analyses of Arkansas, which allowed philosophical vaccine exemptions beginning the 2003-2004 school year have revealed a startling trend which has been observed in other states as well.

Total exemptions numbered 529 in Year 1; 651 in Year 2; 764 in Year 3; and 1145 in Year 4. Between Years 1 and 2, the total number of exemptions granted rose by 23%. After philosophical exemptions were allowed in Year 3, total exemptions granted increased by 17% over the previous year, and by 50% more from Year 3 to 4 (Figure 1).

In Year 3, nonmedical exemptions (including religious and philosophical options) were 1.37-fold higher than nonmedical exemptions in Year 2 (139 versus 64) and 1.67-fold higher than nonmedical exemptions in Year 1 (110 versus 64), when religion was the only option for nonmedical exemptions. In Year 4, nonmedical exemptions (62) were 2.12-fold higher than in Year 2 and 2.58-fold higher than in Year 1. In Years 3 and 4, the majority of the nonmedical exemptions (58% [403 of 700] and 67% [721 of 1083], respectively) were based on philosophical rather than religious (297 and 362, respectively) reasons.

Medical exemptions constituted 21% of all exemptions in both Years 1 and 2. However, with the introduction of philosophical exemptions, the absolute number of medical exemptions dropped by more than half (from 139 in Year 2 to 64 in Year 3 and 62 in Year 4). Thus, medical exemptions accounted for only 8% of Year 3 and 5% of Year 4 exemptions.

Emphasis added.  This is a concerning statistic as it would appear "vaccine-friendly" physicians may have been issuing medical exemptions where they weren't medically-indicated.  This seems to be an unintended finding that should be addressed by public health officials in concert with state medical regulators.

A more recent study conducted by Safi et al. (2012) and includes additional years of data sets has confirmed the previous finding by Thompson et al. (2007).  However Safi et al. included some additional statistics which reveal a number of interesting findings:

Analysis of exemptions by vaccine type revealed that in the 2009 –2010 school year, 70.8% (1922) of exemptions were requested for all vaccines, 9.2% (249) were requested for two or more vaccines, and 20% (543) were requested for a single vaccine. A similar pattern also was seen for previous years. More than 92.8% of single-vaccine exemptions requested were for the measles, mumps, and rubella (MMR) vaccine and 4.6% were for both hepatitis B and varicella. Of 504 single MMR vaccine exemptions, 436 (86.5%) were requested for college students. MMR vaccine is the only required immunization for college enrollment in Arkansas.

The prevalence of children in home schools, not involved in any public school activities, who are undervaccinated is not known, nor of foreign children residing in Arkansas. Even though vaccine exemption–associated outbreaks have not yet been identified during this study period (2001–2010), the increasing trend of exemption in specific colleges in Arkansas raises particular concern because of previous links of infected (symptomatic or asymptomatic) exempted students with mumps and measles outbreaks. ^{[4], [9], [10], [11] and [12]}

Private schools are not included in the collection of these statistics and given the date of the incident, Safi et al. were unaware of this recent Arkansas boarding school measles outbreak. It has also become well-known that Waldorf Schools have become hotbeds for high vaccine exemptions and thus pertussis and measles outbreaks.  The MMR triple jab had the highest number of exemptions for school age and university students which appears to be a shameful repercussion of Wakefield et al.'s fraudulent and retracted Lancet paper even over a decade after the fact.

The recent moves by various states to tighten the ability to acquire non-medical vaccine exemptions are laudable but rather futile efforts that are easily overcome by determined anti-vaxx groups whether it be through convincing credulous politicians to ignore experts in Vermont, lobbying California to include naturopaths as an approved healthcare practitioner to provide vaccine exemption counselling for AB2109 (which is as good as a rubber stamp) and challenging states over the constitutionality of tightening existing religious exemptions such as New Jersey.  Parents who hold these beliefs will not be swayed by a brief meeting with a "healthcare practitioner" who will be undoubtedly shopped for in order to provide a signature needed to be on their way as quickly as possible.  These measures will not increase vaccination rates in any appreciable way.  Political-correctness and pseudo-scientific grandstanding have no business in public health policy, only solid scientific evidence does.

What can States do About Balancing Parental Rights with Public Health?

It's rather easy, in theory at least but would provide parents and public health with the fairest way to balance their respective interests bearing in mind that public health policies are measures to create benefit and protection for the majority of a population.

• Eliminate all religious exemptions and have just philosophical exemptions

States would eliminate, or more realistically reduce the number of legal challenges that can be made by simply providing philosophical exemptions.  There are secular reasons for seeking vaccine exemptions and no religious belief should be deemed superior to another in the matter of exemption from vaccines.

• Enact philosophical exemptions for particular vaccines and all vaccines

Track specific vaccine exemptions rather than make them "all or nothing".  States such as California and Colorado are already doing this (more or less).  This provides more accurate data regarding vaccine uptake and provides schools requisite information to manage outbreaks more fairly and effectively.  As it stands now, any student with a vaccine exemption is required to stay home from school in the event of an outbreak which can mean several weeks out during the school year.  This may be rightfully deserved according to some but ultimately, the children suffer for the parents' actions and tutors are provided by schools at taxpayer expense if a certain number of consecutive days are missed.

Allowing selective exemptions would prevent unnecessary exclusions from school.  For example, a student with an exemption for hepatitis b would be allowed to remain in school in the event of a measles outbreak.  Parents who have an "all vaccines" exemption on file for their children would of course be required to stay home in the event of an outbreak of any VPD.  Outbreak control measures may include requiring students stay out of school for an outbreak of a VPD anywhere in the school district rather than just at the school of enrolment given disease transmission dynamics and incubation periods.

• Standardise criteria for state vaccine mandates

Rigorous criteria for determining which vaccine antigens should be mandated by a state is currently being used in the State of Washington as reported by Lantos et al. (2010):

Washington became one of the first states to develop explicit criteria when its Board of Health convened an Immunization Advisory Committee in 2005 to provide recommendations for how to determine whether a new antigen should be part of the State's required immunizations for entry into school or child care.⁵¹ The Washington State Board of Health realized, in part, that rigorous criteria were needed as it became clear that several vaccines in development were likely to be recommended for children and adolescents and proponents were likely to propose mandates. Indeed, in 2005, the quadrivalent conjugate meningococcal vaccine was licensed, followed by the first human papillomavirus (HPV) vaccine and the first rotavirus vaccine in 2006.

Washington State's 9 criteria are grouped into 3 categories: vaccine effectiveness, public health disease burden, and implementation.⁵² These criteria are meant to sufficiently address the different layers involved in public policy decisions. There are 4 criteria of vaccine-effectiveness; (1) the vaccine containing the antigen has been recommended by Advisory Committee on Immunization Practices; (2) its effectiveness has been established by immunogenicity; (3) it is cost-effective from a society perspective; and (4) it is safe with an acceptable level of adverse effects. The 2 public health burden criteria are (1) that the vaccine containing the antigen prevents a disease that has significant morbidity and/or mortality; and (2) that vaccinating children and adolescents reduces transmission of the disease. The last 3 criteria reflect implementation of the vaccination program: the vaccine must be acceptable to the medical community and the public, the administrative burdens of delivering the vaccine must be acceptable, and the burden of compliance for vaccination is considered reasonable for the parent.

The process for evaluating an antigen for inclusion in school mandates in Washington State involves 3 steps. The Board of Health first does a preliminary review of the antigen of interest to determine whether there is enough information about the antigen for the 9 criteria to be used. Second, a group of representatives from public health, primary care, epidemiology, ethics, and others (such as parents and school administrators) is appointed by the Board. Finally, these appointees review the antigen in question using the 9 criteria and provide a recommendation to the Board. Although these criteria and the process in which an antigen is evaluated against them require some clarifications, they offer a deliberate and informed approach to determining which vaccines should, and should not, be required for school entry.⁵¹ Washington State's Board of Health used these criteria to include the meningococcal vaccine as part of the require immunizations for school entry in 2005. Washington State does not include the HPV or rotavirus vaccines in its school immunization laws.

Other states have come to different decisions. As of June 2009, school mandates exist in 18 states for the meningococcal vaccine,⁵³ and in 2 states (District of Columbia and Virginia) for the HPV vaccine.⁵⁴ No state has a school mandate for the rotavirus vaccines.

Such a process will ensure that an evidence-based approach will be implemented to decide which vaccines should be part of school vaccine mandates.  Such an evidence-based and transparent method may also serve to address some parental fears about vaccinating by addressing individual state's VPD epidemiology.

• Require private and parochial schools to adopt and record the same mandatory vaccines and/or exemptions as public schools

The State of West Virginia (which only has a medical vaccine exemption) requires this already.  Many or most U.S. private and parochial schools do not require vaccines for school entry and/or attract anti-vaxx parents with easy opt outs for vaccines.  Some of these schools have exemption rates of over 80%, particularly Waldorf Schools.  Since schools are the primary sources of disease transmission, there is simply no justification for allowing private and/or parochial schools different standards for vaccine requirements.

• Limit the number of philosophical vaccine exemptions

Given the alarming numbers of philosophical and religious exemptions that some state school districts and counties are issuing, it has become necessary to cap the number of non-medical exemptions for any given school.  These exemptions are based upon pseudo-scientific information that is easily available to credulous parents concerned with vaccine adverse effects; there is no reason to continue to entertain these fallacious beliefs and extraordinary senses of entitlement in the form of high numbers of vaccine exemptions that erode herd immunity.

Herd immunity assumes the equal distribution of susceptible people; this very crucial aspect of herd immunity is compromised by high numbers of non-vaccinated geographically-clustered, particularly at a school level.  In order to achieve herd immunity threshold, the minimum percentage of people vaccinated for a disease is based upon vaccine effectiveness, disease transmissibility or infectiousness (for example measles is far more transmissible than hepatitis b so a higher percentage of people need to be vaccinated for the former than the latter), population mixing and vaccine failure.  For example, measles vaccination uptake to achieve herd immunity threshold is estimated to be 90-93% due to the extremely high infectiousness of measles and an estimated 5% primary vaccine failure rate.  And again, that is also assuming an equal distribution of susceptible people in a large population.

There are several school districts and/or counties throughout the U.S. that do not reach this threshold, California being a glaring example.  Using measles again as an example of how to cap philosophical exemptions and hypothetical school A with a student population of 1000 students, the upper limit for the number of unvaccinated children must be lower than 7% to account for clustering of susceptible children, let's arbitrarily say 4% which would be 40 students.  Medical exemptions would be provided first, next allow selective vaccinators in order of one and two vaccines refused and if the 4% exemption for measles vaccination hasn't been met then full vaccine exemptions can be provided for the remainder.  A higher number of exemptions could be allowed for say, hepatitis a and b but a lower number for pertussis.  Such a system would "reward" those who have their children vaccinated the most according to state mandates and encourage at least some vaccination.

Implementation of philosophical exemptions could be done by lottery and monitoring of medical exemptions which would have the potential for abuse should be considered.

• Requirement of an informed consent statement for philosophical exemptions

This is in line with what Washington State has already enacted and what California may be next in doing.  With all due respect to these state's public health officials, higher standards of informed consent with greater efficiency need to be implemented.  Instead of requiring a signature from a "healthcare provider" which can mean naturopaths who are notoriously anti-vaccine or one of Dr. Bob Sears "vaccine-friendly" doctors, hold public seminars for potential philosophical exemption-seekers with qualified professional scientists and/or physicians.  Said professional scientists and/or physicians would be very familiar with anti-vaccine arguments, websites and purveyors of vaccine misinformation in order to more adequately address parental concerns and objections to vaccines.  A single speaker could reach hundreds of parents at a time taking the burden off of individual providers, disseminate much more relevant information, while dismantling anti-vaccine myths and provide statements of informed consent at the end of the seminar.

Some may ask why even bother to have philosophical exemptions but I feel as though our society can withstand a certain amount of individual freedoms without infringing on the safety of others.  However, there are some areas of the U.S. that appear to have a disproportionate number of parents who feel as though their own entitlements supersede those of the community to the point that once-eliminated or lowly endemic vaccine-preventable diseases are creating outbreaks with their direct actions.

Although philosophical and religious vaccine exemptions are a politically-charged issue, medical science must be the basis for public health decisions and not emotive, politically-motivated ones.  Contrary to popular belief, we do not have a constitutional right to philosophical nor religious vaccine exemptions; the courts have been clear on that.  Such exemptions are a privilege and unfortunately, a privilege which is being abused to the point of endangering society and must be adapted to protect the larger society while maintaining some ability for individual freedoms.

Chicken pox vaccination policy in the UK - did it cost Elana's life?

The UK is often cited in discussions about the chicken pox vaccine. After all, they are a perfectly developed country, they even speak (vaguely) the same language as the US and the NHS's chicken pox policy spells out what (US) vaccine critics have known all along: the disease is harmless in children and vaccinating against it will increase the incidence of shingles in the older population.

The chickenpox vaccine is not part of the UK childhood vaccination programme, because experts think that introducing a chickenpox vaccination for children could increase the risk of shingles in older people. ...

Chickenpox is usually a mild illness, particularly in children. 

This view has been repeatedly challenged. The BBC claimed cost as one major reason the NHS doesn't provide the varicella vaccine and cited Dr David Elliman, immunisation expert at the the Royal College of Paediatrics and Child Health (RCPCH), stating that MMR fears need to be overcome in the UK before a further live viral vaccine could be successfully introduced (more suffering due to the Wakefield/MMR/autism manufactuversy):

"The chickenpox vaccine is definitely desirable, and I think it it will happen, but unfortunately I don't think we are ready for the debate yet - not until we get MMR rates back where they need to be. We need to win that one first."

This is particularly cynical since more patients are dying of chicken pox in England and Wales every year than from pertussis, mumps, measles and hib combined.

Mortality from chickenpox is not negligible. During
1995/­7, 81 deaths were recorded by the Office for
National Statistics. However, we received 119 certifi-­
cates that mentioned chickenpox or varicella. After
detailed inquiries, we estimated that at least 75 were
genuine cases of chickenpox. This suggests at least 25
deaths from chickenpox annually. In 1996/­7 there were
seven certified deaths from whooping cough, mumps,
measles, and Haemophilus influenzae type b (Hib) men-­
ingitis in England and Wales compared with 67 from
chickenpox.

In the meantime, children are either protected by a varicella vaccine purchased privately from a travel clinic (if parents are 1. aware of the option and 2. tenacious enough to find a clinic 3. well off enough to afford this), or they have to suffer through chicken pox. Elana had to have chicken pox and while her brother, who had them first, had a mild case, Elana developed pox in her lungs and died. Just like that:

Elana was three years old when she came out in spots on Easter Sunday 2009. She was fit and healthy and, as her brother had fended off a fairly mild dose of chickenpox the week before, I wasn’t worried. What was to follow has changed my family’s lives forever.

That evening, Elana was a bit tired and wanted to curl up in front of the television but she didn’t seem particularly ill – her spots were not even particularly itchy. But as the week progressed, she seemed to get more lethargic and her condition worsened.

By Thursday, the spots had started to crust over and I thought she should have been getting better but there was no improvement. On Friday night I called the emergency GP and went to a community health centre to have her looked at. The doctor diagnosed Elana with possible pneumonia and recommended that we take her straight to the hospital.

By 11pm on the Friday night we were in hospital and Elana was very unwell. At 6.04am on Saturday morning she suffered a cardiac arrest. Elana was pronounced dead at 7am.

The UK Department of Health touted the party line:

We wrote to the UK government but the Department of Health says severe cases of chickenpox infection are rare and occur mostly in immuno-compromised children. However, I can say from witnessing it first-hand that my daughter was fit and healthy before she picked up the virus. In fact, Elana only ever needed to see a doctor when she was having routine immunisations. I know some other parents who have had the same experience.  

Elana's mum is now spreading awareness of the potential dangers of chicken pox and the availability of the vaccine. It is striking that in the UK, the vaccine is such a well-kept secret that even she, as a nurse, was not aware of it. So: help her - don't let the death of her precious daughter have been wasted. Talk about the vaccine as a real option, tell your neighbours, your GP, your MP, post it on Mumsnet and other fora.

much ado about timing of measles shot

A newspaper snippet is making the round on the interwebz...

Timing of measles vaccine questioned Quebec had a large outbreak of measles in 2011, with more than 700 cases reported. Surprisingly, a number of the teenagers infected had received the recommended two doses of vaccine. A study De Serres did last year showed those who got their first shot at 12 months of age were three times more likely to get infected than those who got their first shot at 15 months of age; his new study put the risk at six times more likely.

We know what will become of this in the claws hands of anti-vaccine vaccine-critical folk. "An outbreak in Quebec where 700 vaccinated teens got measles proves that current vaccination schedule makes teens six times more likely to contract measles". So let's look at the actual study: It analyses measles cases in one high school in Quebec with 1306 students. The index case was a teacher, who imported the measles. This teacher had been vaccinated once. Passive and active surveillance identified 110 students with measles in the following outbreak - I'll bold the notable passage:

Of the 110 student cases identified, 98 were therefore classical (23 laboratory confirmed) and 12 were attenuated (Table 2). Attenuated cases were only found in 2-dose recipients, none of whom had been revaccinated as part of outbreak control.

So out of 1306 pupils, 110 got sick, 12 of them mildly. Mild cases had been vaccinated twice. Have a look at this handy little table:

The overall attack rate among unvaccinated students was 82%,
the overall attack rate among vaccinated students was 4.8%.

Vaccine efficiency was 95.9% for one dose of MMR. It was 95.5% against classical measles and 94.1% against any measles in the 2x vaccinated group. The authors then analysed the 2x vaccinated students to see whether vaccine protection waned with age. That was not the case. Instead they found that for students who were vaccinated at 12 months, vaccine efficiency was 93%, whereas in students who had had their first MMR, it was 97.5%. When you compared those two groups with each other, the relative risk of the 12-months-at-first-vaccination to contract measles compared to the 15 monthers was about 4.35x higher, which was borderline significant (p=0.04). That bit made the news. The fact that measles vaccination offered highly significant protection against measles somehow didn't. Well, now you know.

5 Minutes with Ben Goldacre on what is "bad science" and what is "good science"

Those of you who don't know Dr. Ben Goldacre - go and buy and read his book "Bad Science", now. It may be a bit Britain focussed for the non-Brits out there, but it is a great introduction on how the media and snake oil salesmen and -women take advantage of us and reading the book and understanding its principles will protect you, your health and your wallet. Ben Goldacre takes on the great manufactroversies, like the one about MMR on his blog, his book, in talks he gives, in wonderful short films on health (for example placebo) and in testimony to the British Parliament, and so his debunking work is directly linked to public health (and vaccines). The BBC have interviewed Ben Goldacre in their "5 Minutes with... series" - have a look at the author (and go get the book if you haven't).

Oh, and should you be tempted to comment "pharma shill" or something the like, read one of the below (paperback out on 27 September 2012) on an empty stomach and call me in the morning...

How good is vaccination coverage in your State (US)?

The CDC released the results from their survey of  National, State, and Local Area Vaccination Coverage Among Children Aged 19–35 Months — United States, 2011

Have a browse for the situation in your State - be glad if you are not in the Virgin Islands, I guess. What strikes me indeed is the great inequality between States and also between demographics. Ironically (because anti-vaccine minded parents seem to be concentrated in this group), a white rich child's chance of having been vaccinated age-appropriately are still higher than the chance for a hispanic, black and/or poor child. I was recently discussing vaccine recommendations/mandates and someone argued that only "high risk" children should be vaccinated. The table is a great reminder of how big the United States are and how unequal access to health care is, even when there are uniform recommendations. 

Measlellaneous

Just a short measles miscellaneous of the day. I often come across the notion that it is "immigrants" that re-import vaccine-preventable infectious diseases to the US and that therefore, areas with a high number of immigrants have the highest risk of such diseases. Doctors apparently (achtung: hear say) also like to use that claim to encourage reluctant parents to vaccinate. Two notices appeared on my google feed a couple of days ago:

Fatal outbreak: Measles kills 2 infants in North Waziristan

An 18-month-old girl and one-year-old boy died of measles pneumonitis in Darpa Khel area of tehsil Miranshah, said Agency Headquarters Hospital Miranshah MS Dr Muhammad Sadiq, adding that 25 more people are admitted at the hospital.
The outbreak of measles started in April across the Agency. Sadiq said that in the past week many patients have come from Darpa Khel and Madakhel because the localities have major sanitation problems. “We started vaccinating children but the disease resurfaced after a gap of one month,” he said, adding that most of the vaccines provided by the government have expired because of high temperatures and prolonged power outages.
.../...
The pediatrician said that most of the patients at the hospital were shifted from Khost, Afghanistan. “The Pakistani government could not vaccinate children from Afghanistan and when the epidemic broke there, patients came to Pakistan for treatment, infecting children here.”

These children are not going anywhere. They will get sick and many will die, right where they are, stuck in the middle of nowhere between Pakistan and Afghanistan (or an equally remote place). They do not have the money to make it to the US. So you guys are safe, right? Wrong: the below are the typical import situations:

Officials suspect measles at Arkansas boarding school

LITTLE ROCK, Arkansas (AP) - The Arkansas Health Department says three siblings have been diagnosed with suspected measles and unvaccinated students at a northwest Arkansas boarding school where two of them are students have been sent home.
The agency said Tuesday that one of the siblings had recently traveled to Romania, Italy, and Switzerland. The youth's two siblings became ill while attending Ozark Adventist Academy near Gentry. (my bold)

Voilà - import of measles into the US is essentially a (white) upper middle class problem. Unvaccinated children, exempt from vaccines at their posh fee paying schools, travel to European countries with very high measles incidence (Switzerland has been battling with measles for years, Romania has been the source for US imports before, too), bring measles back to the US and spread it to their siblings and peers (equally unvaccinated). Interestingly, an analysis of vaccine exemptions in Arkansas has just been published, reporting that since the introduction of the possibility of a "philosophical exemption" from immunization requirements in 2003, exemption rates have increased by 23% per year. There has been a drop in medical exemptions at the same time, calling into question the validity of these before the law was changed, however, the overall increase is still striking:

 Even more striking is the authors' prediction (as published in June 2012):

The increases in philosophic exemptions in Arkansas raise concerns that outbreaks of vaccine-preventable diseases may occur in the future.

Outbreaks of vaccine preventable diseases in the United States are very much a "first world", leisure travel-associated problem and therefore, entirely preventable. Check your vaccination status before you travel abroad!

West Virginia Battling Anti-Vaxxers Again

A recent lawsuit was initiated by six West Virginia families against the Department of Health and Human Services (DHHS).  The lawsuit contends:

A half-dozen families are suing the state Department of Health and Human Resources because they say the department is illegally requiring school children to receive certain vaccines.

If successful, the lawsuit could block vaccination requirements for middle and high school students that are in effect this fall for the first time.

The lawsuit was filed late last week with the state Supreme Court. The suit accuses DHHR of improperly adding vaccines to a list of state-mandated vaccines for public school students.

And:

Lane said the lawsuit is not about immunizations in general, but instead about DHHR overstepping its authority. He said DHHR is requiring the vaccine in a rule but that DHHR can't require vaccines without legislative approval.

"I guess, on their own initiative, the agency has attempted to bypass the Legislature and, in our view, illegally add these other compulsory immunization requirements," Lane said. "And the rest of that is if parents do not comply with these additional requirements - the five additional - then their child cannot go to school in West Virginia."

It's about the vaccines; at least be honest about that.  Previously, the West Virginia DHHS required the recommended series of IPV (inactivated polio virus vaccine), DTaP (diphtheria, tetanus and acellular pertussis), MMR (measles, mumps and rubella), Hepatitis B and Varicella.  West Virginia does not allow for religious nor philosophical vaccine exemptions. The DHHS has added:

A recent rule change requires incoming seventh graders in the state to show proof they received one dose of meningitis, tetanus, diphtheria and pertussis vaccines starting in the 2012-2013 school year. Incoming high school seniors must prove they received booster doses after the age of 16. Without vaccination proof from before or shortly after the beginning of the school year, students cannot attend school, Associated Press reports.

That is a booster of Tdap or TD if the child is pertussis exempt for medical reasons and a meningitis (MPSV4 or MCV4) vaccine series of two.  I don't see how Mr. Lane claims it is five additional requirements.

Mr. Lane also refers to a State Code that requires the DHHS to obtain legislative approval for changes in school vaccine requirements.  I cannot find any State Code which specifies this but I am also not a lawyer.  I did find this document which seems to contradict Mr. Lane's claim that the DHHS must acquire State Legislative approval first:

§64-95-7.
Enterers.
Commissioner’s Authority to Change Immunization Requirements for New School

The Commissioner may, by Order filed with the Secretary of State, modify, add or delete vaccines to be required for new school enterers. The Commissioner’s Orders shall be made after consultation with the State Health Officer and shall be consistent with the immunization schedules referenced in section 3 of this rule. The Commissioner’s Orders shall not exceed those recommendations.

In any event, it will be interesting to see what the ruling(s) on this suit will be.

Polio Nearing Eradication

Last week Angola announced there were no new cases of polio since July 2011.

LAUNDA, 10 August, 2012 – Today, Angola marks a year without a new wild poliovirus case, moving the world a step closer to the final global goal of eradicating this contagious crippling disease forever.
After a concerted effort to stop polio transmission the number of polio cases dropped from 33 in 2010 to five in 2011 and no cases registered in 2012. Laboratory results have confirmed that the last case of wild poliovirus was a 14-month-old child from Uige Province in the country's Northwest in July 2011.

This marks a victory for the polio eradication initiative as Angola experienced a resurgence of polio in the last 6 years.

Angola, which eliminated polio from 2001 to 2004, has been plagued by the re-emergence of this crippling disease since May 2005. The disease has since spread from Angola to Namibia (2006), the Democratic Republic of Congo (2006, 2008 and 2010), and the Republic of Congo (2010).

Religious opposition and the U.S. CIA's use of a sham vaccine campaign have caused setbacks in some African and Middle East countries.  However UNICEF is working closely with religious leaders, particularly in Pakistan which has recorded one of the highest number of polio cases in the world.

Several other countries have no polio cases on record thus far for 2012 making only four countries recording polio cases for this year, Afganistan, Nigeria, Pakistan and Chad.  This is good news for global vaccine efforts and the eradication of polio in sight.

♭♩ ♫ what a difference 5 weeks make... ♫ ♬

New Merseyside measles numbers were released Friday and there are now 414 laboratory confirmed cases of measles, plus 173 probably cases. Measles are contagious - so to reiterate from yesterday:

Older pupils, students and adults should check their vaccination records to ensure that they really have had two MMRs, children older than 13 and younger than 41 months could get their second MMR early during an outbreak to reduce the risk.

Consider getting your infant (between 6 and 12 months) vaccinated, if s/he is at "higher risk" (daycare) and there is an outbreak in the area - almost a quarter of cases in this outbreak were in the under one-year-olds, who are at particularly high risk of complications.

Anyone who intends to work/volunteer in the medical sector should have had two MMRs. In this, as in nearly every recent outbreak, transmissions within the medical setting and to medical personnel occurred.

Doctors and nurses need to familiarise themselves with the symptoms of measles, so that they can diagnose them early and limit transmission in the medical setting. 

And finally, all parents need to think long and hard before taking their child into A&E or their GP's practice whether their child could be contagious, especially if the child has not had their MMRs and could be carrying a potentially fatal disease. Call ahead, get an "out of hours" appointment or home visit, if at all possible.

Edited to exchange first link to go to original source

Vaccine Trials: Methods and Best Practices

Time and time again, the strange notion that "vaccines have never been tested in combination" and iterations of that is propagated online and in the media. We had previously addressed this myth, when Dr Bob Sears appeared on Fox Friends. We even presented a handy list of papers, proving how comprehensively vaccines are tested before they can be licensed.

Hexavac with Hepatitis A
Hexavalent vaccine with Rotateq
DTaP with Hib
PCV-13 with all infant vaccines
MMR and Varicella
PCV-7 with MMR, Hib and Varicella
Pediarix with Hib and Infanrix-hexa
New Hib with all infant vaccines
MMR with Varicella
MMR-V with Hib-HepB
MMR-V with all infant vaccines
Meningococcal-C with Hep B and Pentacel
Pentacel with PCV-7

But somehow, it doesn't seem to matter how easily digestible factual information is presented. It is always easier to complain [concerned/enraged/engaged tone on] vaccines have never been tested in combination [tone off; start triumphant gaze].

In my experience, knowledge sticks best when you have honestly worked for it. Here is the chance for anyone who really wants to know how vaccines are tested before licensed - Coursera.org is offering a free online course for anyone interested in the topic, run by experts in Health and Health Education from the Johns Hopkins Bloomberg School School of Public Health.



Go enroll, learn, and the next time you make a claim about vaccine testing you will be equipped to back it up with actual evidence (which is a great feeling).

Meanwhile in London... (with update - day 6)

This boy is on day 3 of fever and chicken pox - new pox are still appearing (usually they do for 5 days after onset) - have a glimpse:



Mum had tried to get her two kids the varicella vaccine,  however,  the NHS does not offer varicella vaccine in their regular schedule. They say

"Chickenpox in children is considered a mild illness, but expect your child to feel pretty miserable and irritable while they have it."

No kidding: have another look at the boy's back - According to the NHS

"The chickenpox vaccine is not part of the UK childhood vaccination programme, because experts think that introducing a chickenpox vaccination for children could increase the risk of shingles in older people."

There are a number of papers, most of them from the same author, "independent computer scientist" Gary S. Goldman, violently arguing that the varicella vaccination programme has led to an increase in the prevalence of shingles, while not really protecting against chicken pox. However, actual data collected in various countries shows a different picture:
In Israel in a partially vaccinated population, shingles were associated with early (especially under the age of 1) infection with wild varicella and varicella vaccine was found to be protective. In Canada, shingles incidence in the vaccinated age group declined slightly, while it remained the same for older age groups. In Taiwan, the incidence of shingles started increasing before the varicella vaccine was introduced. The same was observed in the United States. In Australia, a slight increase on shingles rate occurred over the past 14 years, although this is not as ambiguous as the drop in varicella cases in the same time period, concomitant with the introduction of the varicella vaccine (see box 1 here). And finally, comparing countries with and without general varicella vaccine recommendations showed that shingles incidence seems to be independent of any vaccination programmes.

UK analyses come to the conclusion that a general vaccination programme for varicella may not be cost effective in the first 30 to 50 years after introduction. However, as the picture above impressively demonstrates and systematic studies also show, the impact of varicella on children and cost to carers is not necessarily captured by data available through health service usage.

The positive effect of varicella vaccination on pediatric health is undebated: between the introduction of the varicella vaccine in the US in 1995 and 2006, disease incidence fell by 57% to 90%, hospitalizations by 75% to 88%, deaths by >74%, and direct inpatient and outpatient medical expenditures by 74%. Varicella vaccination reduced the risk of pediatric stroke, a known complication of chicken pox also in the UK, by over 60% (similar observations were made in Italy).

What can I say? Have another look at that photograph - if you are in a country with a varicella vaccination programme, go get the vaccine. If you are in the UK, consider going private for the varicella - it is not fair that you have to pay out of pocket for a vaccination that will ultimately not only benefit your child's health, but also the NHS and your employer, but I would still consider this a good investment. If you are in the UK and you have gotten the varicella vaccine privately, please leave a comment and tell us where and how much it was as a resource for other parents.

ETA (6/6/12): this is day 6 - the young man (6 years old, no history of eczema or any other "condition") is feeling much better, the back is starting to crust over - take a look:

Immunity

I came across this on Ratbags.com - a very short movie by Jasmine Marosvary - this made me think of Nelyn. I met his mum Lynne on ivillage some years ago. The first mother my age, who had lost a child to a vaccine preventable disease. Lynne was lobbying for the licensing of pertussis vaccine for adults, which has since happened. Vaccination saves lives:

Unanswered question

So following my recent post about that paper by Miller and Goldman, which crudely correlates numbers of recommended vaccines with infant mortality rates in the US and any country with a lower IMR, I got mail. Gary Goldman wanted to discuss my criticism with me and explain why they were still right. He actually wanted me to call him, which I was initially tempted to do, but eventually didn't because I was put off by the twisting and turning email conversation. He did request that I keep our exchange private, however, he stopped writing me, so I thought I'd just bring one argument up here and see whether he will answer.

me on 13 May - I (for Germany) and the devine Prometheus (for the US) had asked this earlier:

I see that you are avoiding the most obvious question: why are there fewer and fewer infant deaths when more and more vaccines are given? I gave you the German numbers, where infant mortality dropped by 80% while the number of scheduled vaccines tripled. Every country I look at has the same temporal trend, although in the US it is not as pronounced as in Europe, most likely because of your crappy health system. I would really like to know what your thoughts on this are.

No response to that by Gary on the same day (while was responding to other points)

Me, in response, still 13 May (his points in italics):

I notice you are still avoiding the historical question and if I may make a prediction - you are going to avoid answering this question forever. I would really be interested in your reasoning.

14 May, Gary, at the very bottom of a looong email elaborating on a number of points entirely unrelated to any of my questions:

I am not able to address the specific historical factors concerning infant deaths in Germany upon which you rely to support your contention that no correlation exists. I have seen data where 90% of disease mortality declined prior to vaccinations and this was largely attributed to improved sanitation, nutrition, and water. Other
studies, more longitudinal, and in other populations are reasonably necessary to support the present trend we report.

Now this is really irritating, because we were talking the past 30 years, not "pre all vaccines". Therefore, me, a day later:

Dear Gary,

I should maybe specify

I am not able to address the specific historical factors concerning infant deaths in Germany upon which you rely to support your contention that no correlation exists.

Germany is, of course, not the only country in which infant mortality plummeted over the past 30 years, it did so in every developed country I looked at.

I have seen data where 90% of disease mortality declined prior to vaccinations and this was largely attributed to improved sanitation, nutrition, and water.

Yes, all anti-vaccine protagonists like to refer to such curves. However, I am not talking about disease mortality, and I am talking a period of 1981 to 2011, when sanitation, nutrition and water were not a problem at all in Germany (or any of the other developed countries in which infant mortality dropped over the same time period).

Other studies, more longitudinal, and in other populations are reasonably necessary to support the present trend we report.

But Gary, we already know that infant mortality plummeted while the number of vaccines was significantly increased. I don't think that the kind of crude and error/bias ridden correlation that you have published advance the field at all, or reasonable raises new questions.

What about you? What experiences have you had that have shaped your thinking and views?

Misrepresentation of scientific evidence and dodging of straight forward questions by anti-vaccinationists for example - you wrote many many words, totally side tracking - we were talking German vaccination schedule and how it is not what you wrote about - you have similar misrepresentations for other countries as well - then you write about varicella, which is a second year vaccine - this was not the topic at hand - and you come with "sanitation" when we are talking 1980ies Germany - that is rather lame, you know.

So, given that Germany had great sanitation in 1981 and we are talking infant mortality, not disease related mortality, and they had 9 recommended vaccine doses and 10'000 infant deaths then, while they have 21 to 28 recommended doses and under 2000 infant deaths now, how would number of recommended vaccines correlate with infant mortality at all? Can you give me even an idea, a reasonable notion how your idea would match, umm, reality?

Thanks

Catherina

I had to wait two days to get a response, signed by Miller and Goldman:

Dear Catherina,

Infant mortality rates in all developed nations, including Germany, were much higher in the 19th and early 20th centuries and have continued to decline mainly due to improvements in nutrition (including breastfeeding advocacy), sanitation, and access to healthcare. [This information is not a conspiracy of "anti-vaccine protagonists" as you suggest; it is well-documented in the medical and historical literature.] For example, nearly 300 per 1,000 German infants died in the mid 1800s. By 1950, the German IMR had dropped to 52/1,000—an 83% decline. By 1960, the German IMR had dropped another 33% to about 35 infant deaths per 1,000 live births. These dates and declines in IMR preceded the extensive increases in compulsory vaccinations required of German infants.

Furthermore, Germany’s IMR declined at a rate of 3% annually from 1960 to 1979 during a time when few infant vaccines were required. This rate of decline was much faster than the 2.4% annual "plummet" from 1980 to 2009 during a period when more infant vaccines were required.

Additionally, Germany and other developed nations continued to make medical advances at reducing neonatal mortality during periods of increasing vaccine requirements. For example, from 1970 to 1979 there was a 41% decline in U.S. neonatal mortality. From 1980 to 1989, there was an additional 27% decline in neonatal mortality. Neonatal mortality (deaths in the first 28 days of life) usually accounts for more than 50% of all infant deaths. From 1990 through 2010, neonatal mortality in Germany represented about 68% of all infant mortality. During that period, Germany’s neonatal mortality rate had declined by 55%. Such improvements to the neonatal mortality rate greatly reduce the infant mortality rate yet are unrelated to the number of vaccines administered to infants.

Sincerely,
Neil Z. Miller
Gary Goldman, PhD

So here is my question that I have not gotten an answer for in the past 2 weeks:

Dear Gary,

so if I understand you correctly, infant mortality is dependent on all sorts of factors (hygiene, nutrition, sanitation, access to health care) and still declining, but just not as fast as it would be if we didn't vaccinate. Despite all these factors, which obviously vary tremendously between countries, you decided to only crudely correlate vaccines to infant mortality?

Thank you for clarifying

Catherina

Policy vs. Evidence: Part 1, personal

I have been planning a small series of posts for a while looking at vaccine policy vs. evidence for vaccine policy (i.e. when which vaccine are recommended for which population). This had originally been triggered by the flu vaccine recommendation for under 2 year olds and criticism thereof and some anecdotes on the handling of vaccine recommendations in my own life and online. I will kick off this series with a personal admission:

I am a vaccine refuser/alternatively vaccinating parent - our older child's school holds a current vaccination "non consent" form.

That is the short story. The long story is a little more complex. In the UK, children get their booster shots in school. They are paid for by the National Health Service. So last year, we got a letter home, asking us for consent to a dT/IPV (Diphtheria, Tetanus, inactivated Polio vaccine) booster. Well, it was 9 years after the dT pre-school booster, so the dT was a very good idea. The IPV however, we did not quite see as critical. Polio has been eradicated in the Western Hemisphere (this was before the Russian polio import from Tajikistan. Both children had had 4 polios. More importantly, however, I wanted the kids to be boosted for pertussis (routine on the German teen schedule). First of all, we know that pertussis immunity wanes, whether you had the shots (see also here) or coughed for it, then we know that the booster works for teens, adolescent and adult vaccination was likely to be cost effective, and finally, I had pertussis as a 15 year old (from babysitting an unvaccinated toddler) and I was not keen on anyone in the family living through a summer of relentless choughing. Pertussis is not nick-named "100 day cough" for nothing.

This was an interesting experience. The nurses from the school immunisation service could not help me with a dTaP (aP = acellular Pertussis) or dTaP/IPV. They were nice, though. The GP referred us to the health visitor, who only does babies and toddlers. The nurse from the travel vaccine section of our GP practise hung up on me after I had explained our wishes, with very little patience for something extraordinary. So finally, we landed in a private practise, one of those places that used to make money by selling the single M(easles), M(umps) and R(ubella) vaccines (call me hypocrite). While the nurse was clueless, she was exquisitely friendly, she did not hang up on me, so I could explain which vaccine we wanted, then explained to their resident GP that while that particularly vaccine was not licensed for kids over 10 years in the UK, it was in a lot of other countries (German pdf; I know because DH and I got the same vaccine in 2005). And eventually, after a reasonable office fee and a surprisingly cheap booster shot (£5 a pop), the whole family was back on track. Phew. So when the school sent out another consent form this year, we responded back with another non-consent (and an explanation why we did not consent).

In the end, the whole procedure was extremely sobering. Our decision to vaccinate our school children against pertussis was totally backed by evidence, biologically relevant and followed European recommendations, just not the UK's. In our opinion, the current UK policy was lagging behind the available evidence, even studies from the UK. It required a fair amount of perseverance and the luxury of some dispensable money to protect our children what we considered adequately.