Today’s narrative is that vaccines need to be mandatory to stop measles and other diseases “making a comeback.”

While philosophical and now religious exemptions are under attack, current triple shots (DTaP/TdaP, MMR) are slated for mandatory use in Mississippi, West Virginia and now Maine, California and New York.

But while we all argue about measles (“it’s deadly!” … “no it’s not!”), and while vaccines that used to be  “recommended” are now becoming required in some states,  new vaccines are rolling onto the market.  And more new technologies are coming. These newer vaccines will no doubt be phased into the vaccination schedules of schoolchildren. Measles vaccine is but one of many.

Usually new technology is a good thing – but how do you feel about a mandatory 6-in-1 vaccine?

Take, for example, the new six-in-one vaccines, slated to hit the US market in 2020, according to Forbes (“How About 6 Vaccines In One? FDA Approves New Vaccine From Sanofi, Merck” – Dec. 28, 2018).

Above from: AAP Vaccine Coding Guide

“In late December, the FDA approved Vaxelis, the first six-in-one vaccine to contain diphtheria and tetanus toxoids and acellular pertussis adsorbed (Dtap); inactivated poliovirus; Haemophilus influenzae type b (Hib) conjugate; and hepatitis B recombinant for use in children aged 6 weeks through 4 years (before their 5th birthday). Given as a three-dose series by I.M. injection at ages 2, 4, and 6 months, the vaccine was developed jointly by Merck and Sanofi and will be commercially available in 2020.” – Pharmacy Today, March 2019.

How do you feel about genetic modification? How do you feel about recombinant and DNA vaccines? Proponents of mandatory vaccines say that how you feel doesn’t matter.

From the FDA:

Product Information

Supporting Documents

Some may feel comfortable with the safety profile – or yet others may see that the testing required to get these products to market was inadequate. Consumers may want to have single shots – not six in one. But they won’t have those choices, if they allow their rights to be abolished with the passage of laws removing “exemptions.”

In Vermont our right to exercise our philosophical objections was red-lined in 2016. Fortunately, legislation that abolishes our remaining right to file religious vaccine exemption has not moved through committee, because an increasing number of our lawmakers understand this is a bad idea. Still others need to hear from concerned constituents.

Many lawmakers do not even know how many vaccines they are green lighting when they say that they need “to get vaccination rates up” ; and the ones that do, are cautious and under heavy pressure from the medial industry to abolish rights and make vaccines mandatory for school.

But the need to hold onto our rights to know and our right to choose could never be more important.

In 2018 In India, the safety record of a different six-in-one vaccine, the Infanrix Hexa vaccine by GSK, was  analyzed and called into question by Jacob Puliyel, Head of the Department of Pediatrics at St Stephens Hospital in Delhi (see:  Infanrix hexa and sudden death: a review of the periodic safety update reports submitted to the European Medicines Agency” by Dr. J. Puliyel in the Indian Journal of Medical Ethics.)

In 2015 in Canada, Infanrix Hexa 6-in-1 vaccine GSK was investigated alongside a 4-in-1 vaccine vaccine for its role an increasing number of large local reactions (“LLR”) defined as local injection site reactions (redness, swelling, pain) reported by a health professional extending beyond the nearest joint or lasting  4 days or sterile or infectious abcess or cellulitis treated with antibiotics. Quebec was the only Canadian province to recommend these combination vaccines at the 18-month visit and a large proportion of patients experiencing “LLR” had received both vaccines in the same limb.

– Jacob Puliyel in Indian Journal of Medical Ethics Vol III No 1 January-March 2018

Are all “adverse events” following vaccination, caused by the vaccinations? Of course not. However, it is not credible to claim that there are no serious adverse effects or deaths caused by vaccines – because consumers report them all the time. But in many cases, the victims of the adverse effects are very young infants, newborns having only just taken their first breath and in perfectly good health prior to receiving the vaccine. This is where listening to the parents, becomes critical. #believemothers. Perhaps the combination vaccines will be easier to pinpoint than the multiple single shots they give in different limbs on the same visit, today.

Back to Infanrix.

When clinical trials are run by the companies seeking license to market the products, they have to follow the participants closely, and alert regulatory authorities (the FDA, the EMA for example), if anything goes wrong. In this case, the vaccine maker GlaxoSmithKline would be collecting and analyzing any “events.” They only administer the vaccine to healthy subjects. There is long list of who cannot get the vaccine. This list should probably be the list of those who should not get the vaccine post-market, too – but that is not how things work. We will save this topic for another post.

Adverse events that occur during clinical trials are rarely known by the public. However, in 2012, a confidential report from GlaxoSmithKline (“GSK”) concerning the 6-in-1 combination shot “Infanrix Hexa” vaccine, was leaked.  According to Initiative Citoyenne, a Belgian watchdog group:

“The document in question details the adverse effects of this vaccine, reported back to the manufacturer from various European countries between the 23rd of October 2009 and the 22nd of October 2011.  We can understand why it is confidential: no less than 825 different types of complication and adverse effect are mentioned.

It is important, first of all, to point out that the list covers a very broad range of adverse effects potentially involving each and every system and organ in the body: the blood, the cardiovascular system, the nervous system, the immune system, the lungs, the skin but also the sensory organs (sight, hearing…), the musculoskeletal system, the joints, the urinary system, the digestive system and the endocrine system.

During this specific period of time, GSK received 1,742 reports of adverse effects, of which 503 were serious effects not listed and 56 were serious adverse effects listed.  The events registered included 36 deaths (over the two-years period), most of which occurred within three days after the child received the Infanrix Hexa vaccine– Source: Initiative Citoyenne Press Release.

View the full “confidential” leaked document concerning Infanrix Hexa Vaccine, here.

It seems these combination vaccines should be the parent’s choice.

 

 

 

written by: Jennifer Stella