ABOUT PENTA VACCINE
According to Health Canada's own regulations the use of the combination vaccine called PENTA was not compliant with the law. This product had neither NOC nor DIN (Drug Identification Number, a license). Both processes help mitigate risks and allow for closer monitoring of adverse events.
In 1994, the first 5-in-1 to make it into a heavily competitive vaccine market was PENTA (DPT-Polio-Hib PRP-T) by Connaught (North American arm of Institut Merieux of France later bought by Aventis and now owned by Sanofi). It was used only in Canada. Click to see an image of PENTA in its original packaging.
PENTA was a marketing name given to a combination of two licensed vaccines to create the first ever routinely administered 5 vaccines in a single needle. It consisted of: a powdered lyophilized Act-HIB (a Haemophilus b conjugate vaccine made with a tetanus toxoid) that was reconstituted in a liquid DPT-Polio adsorbed (diptheria, whole cell pertussis, tetanus and polio vaccines). According to Health Canada this combined third product was not licensed for use in Canada. It did not have a Drug Identification Number (DIN).
Read the admission by Canadian Biologics and Genetic Therapies Director that PENTA was unlicensed -- it did not have a Drug Identification Number (DIN)
Read a letter to parent Pierre Morin from Canadian Biologics stating it is "illegal to distribute an unlicensed vaccine in Canada".
Nor did PENTA receive approval through a process called Notice of Compliance (NOC). Rather, in January 1994, the Canadian Biologics provided a NOC to revise the package insert to state that the Act-HIB may be reconstituted with Connaught’s DPT Polio Adsorbed vaccine. Read this NOC here. Read the product monograph.
RED FLAGS IGNORED
In addition to being unlicensed, the safety and efficacy of PENTA was questioned: all of which should have been a red flag preventing its use on children.
Never before had children been routinely vaccinated with five vaccines in one needle. And yet, there was just one study on safety prior to the release of PENTA. Click to read this published study.
In this study doctors acknowledged their ignorance regarding the "interactions observed among the components of the pentavalent vaccine". There were systemic reactions to the vaccine and concern regarding its inefficacy.
Health Canada also acknowledged at the time that "there is insufficient information regarding the lot-to-lot variability in immunogenicity or reactogenicity of PRP-T when given in combination with either DPT or DPT-IPV." Read more.
Not only did the manufacturer and government appear to ignore these red flags but also they side-stepped the licensing process.
Why did the manufacturer move so fast to get this unlicensed product to market?
NO LEGAL RECOURSE?
A pharmaceutical company with an unlicensed vaccine was allowed access to children by Health Canada. What does this mean?
We believe that the long term outcomes for many of the PENTA children included life threatening allergies and autism but there was no public follow-up on the children to confirm this. Neither doctor nor government nor corporation followed up individually on these children because there was and is no incentive to do so. There is no legal recourse for vaccine injury (limited in Quebec).
And today, 20 years later what meaning does PENTA have outside of those immediately impacted? Given that the prevalence of life threatening allergy and autism has grown dramatically (4% of boys are now on the autism spectrum) and that there is still no legal recourse for those injured is it reasonable to conclude that the conditions that gave rise to PENTA have not changed?
PENTA is a cautionary tale for Canadian vaccine consumers who remain unprotected.