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I was sent a Mercola article in which he comments on the "risks" of newborn Hepatitis B vaccination. This question is not about autism; I'm purely interested in two of the claims:

  • Risk of adverse effects:

The array of serious health problems people have reported experiencing after hep B vaccinations is quite shocking: Multiple sclerosis (MS), Guillain Barre syndrome, Bell's Palsy, Diabetes, Rheumatoid arthritis, Lupus, Idiopathic Thrombocytopenia purpura, Convulsions, and brain disorders such as encephalitis (brain swelling) and brain demyelination, Immune dysfunction, Visual and hearing impairments, including optic neuritis, Pancreatitis

Citing Barbara Loe Fischer, the founder of the National Vaccine Information Center (NVIC), Mercola writes:

There is no common sense applied to this recommendation and implementation because the child is only at risk for hepatitis B if the mother has the active infection. So why don't we just test the mother for hepatitis to see if the vaccine is warranted, instead of routinely vaccinating all babies? This would not only protect the child from unnecessary harm, it would also be far more cost effective.

"I think cost effectiveness is something that really needs to be looked at in this economic climate that we're in," Fisher says.


So, the first claim is one of safety, suggesting that it's not safe for newborns to receive the Hep B vaccine. Perhaps a helpful statement for formulating a specific claim is (from teh first article):

For most children, the risk of a serious vaccine reaction may be 100 times greater than the risk of hepatitis B.

I found the CDC info brochure on Hep B, which states:

Severe problems are extremely rare. Severe allergic reactions are believed to occur about once in 1.1 million doses.

So, is risk of Hep B something like 1 in 110 million for children? In other words, does the Hep B vaccine produce a higher rate of "serious vaccine reactions" to newborns than the number of Hep B infections in unvaccinated 5-7 year olds (the length of time the Hep B vaccine offers protection per Wikipedia)?

Lastly, is the unanimous vaccination decision for newborns less cost effective than testing suspect mothers and only vaccinating those who test positive?

This might be tricker to answer, as "total cost" might come down to:

  • Less efficient to run ad-hoc tests (requiring lab work) than the cost of all of the vaccines kept on-hand?
  • Total cost of Hep B if acquired by a newborn vs. cost of vaccines + any potential adverse effects?
  • Other factors?
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    So, is risk of Hep B something like 1 in 110 million for children? Fist of all, the risk of getting Hep B is probably much higher than 1 in 110 million, even for children. Although, the rate for children would be lower. The thinking is that getting a vaccine while young is probably the most effective method of getting a lifelong immunity. Each year there are about 46,000 new hepatitis B virus infections in the United States alone. There are about 1.4 million people with chronic hepatitis B infection in the United States, but worldwide, approximately 350 million people are infected. – Larian LeQuella Jul 24 '11 at 18:17
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    @Larian: thanks for the initial stats. I'd be interested in data supporting reduced risk of Hep B by virtue of newborn vaccination. That would definitely assist in putting these types of claims to rest. – Hendy Jul 24 '11 at 19:12
  • not sure that I can easily assemble that data. Only because the time-frame we are talking about. The most analogous data may be a look at pertussis vaccine rates. What is the re-vaccination rate of young adults who should be getting a booster? I wasn't able to find much, although the titles of some papers would indicate it is much lower than it should be. – Larian LeQuella Jul 24 '11 at 23:18
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    Almost anyone with hep b would tell you that the costs assciated with getting it are not the worst part of it. – Chad Jul 25 '11 at 14:50
  • @Hendy see the chart in my answer, newborn vaccination began in 1991 in the US and incidence has been declining since. – John Lyon Jul 26 '11 at 0:24
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Does the Hep B vaccine produce a higher rate of "serious vaccine reactions" to newborns than the number of Hep B infections in unvaccinated 5-7 year olds (the length of time the Hep B vaccine offers protection per Wikipedia)?

First of all, there have been no recorded deaths due to reactions to current vaccines, and the claims of MS (possible increased risk, needs further research), Bell's Palsy (one single case, no causal link proven, patient recovered within weeks), SIDS (not caused by vaccine) and other adverse affects are either fairly flimsy or completely baseless. With so many children being vaccinated, one would expect an increase in the instances of these health problems from 1991 onwards, when universal Hep B vaccination was introduced. I have seen no such research.

On the other hand, Chronic Hepatitis B is incurable, can result in liver cirrhosis, liver cancer, and death, so an instance of Hep B infection and an instance of adverse reaction (normally a severe allergic reaction) should not be compared as though they are equal in severity.

Secondly, selecting the 5-7 age group is flawed for a few reasons:

  • Most infants have been vaccinated in the US since 1991
  • Many infants maintain some immunity beyond the expected 5-7-year efficacy lifetime of the vaccine
  • Some infants are vaccinated at birth, others much later (up to 32 months old), so it's not as though every child is vulnerable to Hep B at ages 5-7,
  • Infection rates would be different for newborns and 5 year olds.

As to the rate of adverse reaction, this page cites Vaccines: What You should know, 3rd edition for the following stat:

The hepatitis B vaccine has few side effects. However, one side effect is serious. About one of every 600,000 doses of hepatitis B vaccine is complicated by a severe allergic reaction called anaphylaxis... Although no one has ever died because of the hepatitis B vaccine... Children are much more likely to develop these severe and often fatal consequences of hepatitis B virus infection if they get infected when they are very young. For this reason, the hepatitis B vaccine is recommended for newborns.

As to the risk of infection for unvaccinated infants, this is extremely difficult to measure, for the reasons stated above - nearly everyone is vaccinated nowadays. Nonetheless, this CDC page states the following infection rate for unvaccinated infants of uninfected mothers before universal vaccination was introduced:

approximately 33,000 children (10 years of age and younger) of mothers who are not infected with hepatitis B virus were infected each year before routine recommendation of childhood hepatitis B vaccination.

This page lists the US birth rate in 1990 at around 4 million, so the chance of contracting Hep B before the age of 10, if universal immunization is not used, is very roughly 1/121.

Infected children are also far more likely to develop chronic symptoms, be carriers, and pass the virus onto others. It is currently recommended that all infants receive the vaccine before leaving the hospital for this reason.

Pregnant women are screened for the virus as the vaccine should be given to infants within 24 hours in the case of an infected mother. In the case of an uninfected mother, the CDC recommends vaccination before hospital discharge.

This CDC page gives the coverage figure for expectant mothers:

Recent estimates indicate that >95% of pregnant women are tested for HBsAg, and case management has been effective in ensuring high levels of initiation and completion of postexposure immunoprophylaxis among identified infants born to HBsAg-positive women. Hepatitis B vaccine has been successfully integrated into the childhood vaccine schedule, and infant vaccine coverage levels are now equivalent to those of other vaccines in the childhood schedule. During 1990--2004, incidence of acute hepatitis B in the United States declined 75%. The greatest decline (94%) occurred among children and adolescents, coincident with an increase in hepatitis B vaccine coverage. As of 2004, among U.S. children aged 19--35 months, >92% had been fully vaccinated with 3 doses of hepatitis B vaccine (8). This success can be attributed in part to the established infrastructure for vaccine delivery to children and to federal support for perinatal hepatitis B prevention programs.

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Is the unanimous vaccination decision for newborns less cost effective than testing suspect mothers and only vaccinating those who test positive?

No.

This question is flawed as explained above - although everyone receives the vaccination within 6 days of birth, children of HB infected mothers require the vaccination within 24 hours of birth, and over 95% of pregnant women in the US are already screened. The reason for vaccinating every child is to eventually eliminate the virus.

As to cost, this study (paywall) is admittedly a bit dated, coming from 1993, but I suspect the cost of vaccinations has dropped considerably since then (citation needed). It compares the cost of vaccinating all newborns with the costs of treating the illness if this wasn't done. It should be noted that universal vaccination has since been adopted in the US and is recommended by the WHO. I don't have full access, but from the abstract:

A decision-analytic model involving a Markov process to model the long-term sequelae of HBV infection was constructed to estimate the expected costs and life expectancies for a cohort of newborns under two strategies: the current screening policy (SELECTIVE), which involves active and passive vac cination of infants born to carrier mothers, and a policy that combines the current screening strategy (including active and passive vaccination of infants born to carriers) with active vaccination alone for children of non-carriers (UNIVERSAL). A hypothetical cohort of children born in either Canada or the United States in 1991 was examined. Cost estimates were derived for Ontario. From a societal perspective, the incremental cost required to achieve one extra life year was found to be $30,347, comparable to the cost-effectivenesses of other health care strategies commonly used in North America. The result is sensitive to the duration of vaccine effectiveness and particularly to the price of the vaccine. Universal vaccination results in net cost saving at a vaccine price of approximately $7 per dose, from a societal perspective. It is concluded that universal vaccination against HBV in infancy is economically attractive, comparable in cost-effectiveness to existing health care interventions. Lower vaccine prices would substantially improve the attractiveness of such a program. Implementation of universal vaccination should be considered in North America, contingent on vaccine price reduction.

It should also be noted that vaccinating all children is not done purely for cost reasons. From this CDC page:

HepB vaccination of newborns also provides early preexposure protection to infants born to uninfected women during a period when, if HBV exposure were to occur, the risk for developing chronic HBV infection is greatest (i.e., during the first year of life). Infants who become HBV infected have an approximately 90% risk for developing chronic HBV infection, and when chronically infected, have a 25% risk for dying prematurely from cirrhosis or liver cancer. Thus, newborn HepB immunization is a key intervention to prevent perinatal HBV transmission and a critical strategy to reduce the global morbidity and mortality associated with hepatitis B.

Infants can contract Hep B from a number of sources (infected persons, latent blood/saliva, needle stick injuries, etc.). The aim of infant vaccination is to eventually lead to the elimination of Hepatitis B.

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    Great answer. Sorry it took me so long to thoroughly read it and respond to you. Fantastic work. I'd +5 if I could. – Hendy Sep 13 '11 at 15:33
  • Odd it is not standard in the UK, yet the UK is very keen on vaccinations. – Ian Ringrose Jun 3 '16 at 14:56

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