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Editor's Choice

A tale of two vaccines

BMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k4152 (Published 04 October 2018) Cite this as: BMJ 2018;363:k4152

Pandemrix and Arepanrix vaccine safety analysis and scrutiny fell short

Dr Philip Bryan writes in https://www.bmj.com/content/363/bmj.k4152/rr-11 :
“We believe that the safety of both Pandemrix and Arepanrix vaccines have been scrutinised entirely appropriately”

Not true. Wraith et al.(1)⁠ and Verdier(2)⁠ suggested in 2003 that bioinformatics analysis be performed to avoid antigens in vaccines that have molecular mimicry to human self antigens. Where is the analysis?
Wraith et al. called for autoimmune serology in clinical trials. Where is that data?

The nucleoprotein (NP) sequence for A/Puerto Rico/8/1934, the backbone of X-179A that was used in Pandemrix, became available in 1985(3)⁠. The human hypocretin receptor 2 (HCRTR2) sequence became available in 2000.(4)⁠

Even a quick bioinformatics analysis would have identified autoimmunity risk of NP in the vaccine. A detailed analysis may have even predicted sequence alignment to HCRTR2 as a narcolepsy risk. And this could have been done long before the pandemic because it is relevant to seasonal influenza vaccine safety as well.

References

1. Wraith DC, Goldman M, Lambert P-H. Vaccination and autoimmune disease: what is the evidence? Lancet (London, England). England; 2003 Nov;362(9396):1659–66.
2. Verdier F. Chapter 14 - Preclinical Safety Evaluation of Vaccines A2 - Thomas, John A. In: Fuchs RLBT-B and SA (Third E, editor. San Diego: Academic Press; 2003. p. 397–412.
3. Beklemishev AB, Blinov VM, Vasilenko SK, Golovin SI, Karginov VA. [Synthesis, cloning and determination of the primary structure of a full-size DNA copy of the NP protein gene from influenza virus type A]. Bioorg Khim. Russia (Federation); 1985 May;11(5):636–40.
4. UniProt: the universal protein knowledgebase. Nucleic Acids Res. 2017 Jan 4;45(D1):D158–69.

Competing interests: No competing interests

11 October 2018
Vinu Arumugham
Engineer
San Jose, CA, USA