{"id":2285,"date":"2019-05-09T10:10:14","date_gmt":"2019-05-08T22:10:14","guid":{"rendered":"https:\/\/blog.waikato.ac.nz\/bioblog\/?p=2285"},"modified":"2019-05-09T11:52:15","modified_gmt":"2019-05-08T23:52:15","slug":"the-package-insert-misunderstood-misrepresented","status":"publish","type":"post","link":"https:\/\/blog.waikato.ac.nz\/bioblog\/2019\/05\/the-package-insert-misunderstood-misrepresented\/","title":{"rendered":"the package insert: misunderstood & misrepresented"},"content":{"rendered":"

UNICEF estimates that in the period 2010-2017, 169 million children missed their first dose of the measles vaccine<\/a> – that’s around 21 million children each year. Sadly, this has simply set the conditions for the measles outbreaks we’re seeing around the world, in high- and low-income countries alike.<\/p>\n

In the first three months of 2019, more than 110,000 measles cases were reported worldwide \u2013 up nearly 300 per cent from the same period last year. An estimated 110,000 people, most of them children, died from measles in 2017, a 22 per cent increase from the year before.<\/p><\/blockquote>\n

The US leads the list of high-income countries with a sizeable pool of kids who didn’t receive that first dose of measles vaccine: 2,593,000 children between 2010 & 2017.<\/p>\n

There, as elsewhere, the UN’s World Health Organisation has identified ‘vaccine hesitancy’<\/a> as a significant underlying reason for this shortfall, And as I’ve said previously, that lack of confidence is at least partly due to the activities of anti-vaccine individuals and organisations.<\/p>\n

Including those who tell anyone who disagrees with them to “read the package insert”, for there we’ll find hidden in plain sight the evidence that vaccines really are bad. Like the individual below<\/a>:<\/p>\n

\"\"<\/a><\/p>\n

Tipene is actually talking about the Vaccine Information Statement from the CDC, which you can find here<\/a>, and which summarises information also presented in the vaccine package insert. In talking about “severe” adverse events, he’s omitted the sentence,\u00a0Severe events occur very rarely<\/em>, which puts a slightly different perspective on things (see below).<\/p>\n

And regarding the nature of adverse reactions, it’s worth going to the actual package insert<\/a> (the one that those opposed to vaccination seem to think that no-one else has read). Right at the top of that section of the (relatively lengthy & detailed document), you’ll find this statement (my emphasis):<\/p>\n

ADVERSE REACTIONS
\nThe following adverse reactions are listed in decreasing order of severity, without regard to causality<\/strong>,\u00a0within each body system category and have been reported\u00b9 during clinical trials, with use of the marketed\u00a0vaccine, or with use of monovalent or bivalent vaccine containing measles, mumps, or rubella:<\/p><\/blockquote>\n

That is, the list is generated from events reported during clinical trials or in post-introduction surveillance,\u00a0whether or not an actual causal relationship has been demonstrated.<\/em>\u00a0Notably, that section on adverse reaction also includes information on the frequency of those reactions; for example:<\/p>\n

Encephalitis and encephalopathy have been reported approximately once for every 3 million doses of\u00a0M-M-R II or measles-, mumps-, and rubella-containing vaccine administered since licensure of these\u00a0vaccines.
\nThe risk of serious neurological disorders following live measles virus vaccine administration remains\u00a0less than the risk of encephalitis and encephalopathy following infection with wild-type measles (1 per 1000 reported cases)<\/p><\/blockquote>\n

Where there is<\/em> a causal relationship, with evidence of harm in some circumstances, that information is included in an earlier section of the document. The one with the big black header,\u00a0WARNINGS.<\/p>\n

Now, here’s a thought. Tipene & others opposed to vaccination are happy to accept that the package inserts are accurate in listing a range of adverse events (albeit conveniently ignoring the caveat about causality or lack thereof). Yet they also argue that vaccines are ineffective, ignoring the material in an earlier section of the insert<\/a>:<\/p>\n

The impact of measles, mumps, and rubella vaccination on the natural history of each disease in the\u00a0United States can be quantified by comparing the maximum number of measles, mumps, and rubella\u00a0cases reported in a given year prior to vaccine use to the number of cases of each disease reported in\u00a01995. For measles, 894,134 cases reported in 1941 compared to 288 cases reported in 1995 resulted in a\u00a099.97% decrease in reported cases; for mumps, 152,209 cases reported in 1968 compared to 840 cases\u00a0reported in 1995 resulted in a 99.45% decrease in reported cases; and for rubella, 57,686 cases reported\u00a0in 1969 compared to 200 cases reported in 1995 resulted in a 99.65% decrease.{3}
\nClinical studies of 284 triple seronegative children, 11 months to 7 years of age, demonstrated that\u00a0M-M-R II is highly immunogenic and generally well tolerated. In these studies, a single injection of the\u00a0vaccine induced measles hemagglutination-inhibition (HI) antibodies in 95%, mumps neutralizing\u00a0antibodies in 96%, and rubella HI antibodies in 99% of susceptible persons.<\/p><\/blockquote>\n

Something of a pro-plague paradox, really.<\/p>\n

 <\/p>\n

 <\/p>\n

\u00b9 The US has the Vaccine Adverse Events Reporting System (VAERS). much beloved by those opposed to vaccination as it “shows” the harm from vaccines. However, this is a voluntary reporting system that makes no conclusions about causation. The VAERS website is here<\/a>, and its front page includes a disclaimer (which you should read before using the site) which ends:<\/p>\n

Note that the inclusion of events in VAERS data does not imply causality.<\/p><\/blockquote>\n

A search for <VAERS ID> + <MMR> + <deaths> for the period 1990-2019 yields 244 results<\/a> – with around 28,000,000 doses of MMR vaccines administered in the US in that period of time<\/a>. While this list contains deaths where doctors felt that vaccination might be or were implicated, it also includes many where they clearly did not, including deaths from mechanical asphyxia (e.g. 252078-1), meningococcal infection (e.g. 207834-1), coronary artery disease (351934-1), and cancer (e.g. 213168-1).<\/p>\n

The mortality rate for measles infection is around 1 in 1000<\/a>, in developed countries with high standards of healthcare<\/em>. In poorer countries, that figure can be as high as 1 in 10.<\/p>\n

 <\/p>\n

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UNICEF estimates that in the period 2010-2017, 169 million children missed their first dose of the measles vaccine – that’s around 21 million children each year. Sadly, this has simply set the conditions for the measles outbreaks we’re seeing around the world, in high- and low-income countries alike. 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