Intended for healthcare professionals

Rapid response to:

Feature

Pandemrix vaccine: why was the public not told of early warning signs?

BMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3948 (Published 20 September 2018) Cite this as: BMJ 2018;362:k3948
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Adverse events: GSK pandemic influenza vaccines

Read all The BMJ's investigations

Rapid Response:

Pharmacovigilance is no substitute for good vaccine design

Prof. Sturkenboom writes in https://www.bmj.com/content/362/bmj.k3948/rr-7 :

"Not all adverse reactions can be predicted, and narcolepsy (a very rare disease) had never been associated with vaccines before: the signal came as a complete surprise in August 2010."

Why did the Pandemrix vaccine contain the H1N1 nucleoproteins in the first place? While narcolepsy specifically may have been difficult to predict, autoimmunity due to molecular mimicry is to be expected especially with an adjuvanted vaccine. The more non-target proteins in the vaccine, the higher the probability of autoimmunity. This is not rocket science.

"As of yet it is unproven what the mechanism was ..."

Not true. Ahmed et al. below have described the mechanism.

Antibodies to influenza nucleoprotein cross-react with human hypocretin receptor 2.
https://www.ncbi.nlm.nih.gov/pubmed/26136476

"Pandemrix, Focetria and Celvapan were licensed faster because of rigorous mock-up data, where the vaccine construct (including the adjuvant) is already tested, but only the strain is replaced. "

If you replace a strain with no molecular mimicry to human self proteins with one that does, how does any previous testing help?

"it was established that Europe should have a sustainable platform for multinational epidemiological research which would allow for rapid quantification of safety signals."

That's the wrong priority. Removing ALL non-target proteins from ALL vaccines immediately will avoid generating these "safety signals" in the first place.

Pharmacovigilance and pharmacoepidemiology are no substitute for good vaccine design practice. Pharmacovigilance and pharmacoepidemiology means you are depending on a lot of people being sickened by a vaccine to generate a "signal". It is then already too late.

"use our energy to further improve big health data collaborations that have demonstrated the ability to provide post-licensure safety data"

Instead, "big health data" that we already have (bioinformatics) could have been used to prevent narcolepsy and numerous other vaccine-induced diseases.

Cancer immunology, bioinformatics and chemokine evidence link vaccines contaminated with animal proteins to autoimmune disease: a detailed look at Crohn's disease and Vitiligo
https://doi.org/10.5281/zenodo.1034776

"Our main concern is that the paper plays on emotions of fear and anger of the public, fostering mistrust and suspicion,..."

As retired pediatrician Allan S. Cunningham asks in his rapid response: "Where is the outrage?"

Unfortunately, vaccine makers and regulators have earned the outrage.

Vaccine safety claims simply do not stand up to scrutiny.

https://www.bmj.com/content/360/bmj.k1378/rr-0

Every aspect of vaccine safety needs an immediate overhaul.

Competing interests: No competing interests

28 September 2018
Vinu Arumugham
Engineer
San Jose CA, USA