More MHRA Responses on the H5 Avian Influenza Vaccine

A response from the MHRA

In our Summary of the UKHSA and MHRA information received about the H5 Avian Influenza Vaccine, we kept our readers updated with the response received and our deciphering of why and how our money is being spent.

Summary of the UKHSA and MHRA information received about the H5 Avian Influenza Vaccine.

And we explained our confusion.

Ruminations of Old Geezers - More on a Confusing Read

On Friday, Tom received more information from a review of the FOI he had requested.

The MHRA reply is the first clear indication of what went on.

The response is quite long and contains a convoluted apology (written in strange prose) for lack of clarity in responding, which is a time-wasting factor in all of these requests.

The two screenshots contain the most essential points.

This childish sketch shows you the nuts and bolts of what the MHRA is saying: EMA and MHRA consider all three current licensed or semi-licensed avian influenza vaccines bioequivalent to Sanofi’s Aflunov, which was licensed 15 years ago.

Our sharp-eyed reader Maurice McCarthy picked up the significance of this hey presto, probably because he is following the exchange on WhatDoTheyKnow. His comments are worth a read.

The MHRA never assessed these vaccines, leaving the job to the EMA 15 years ago. The picture is incomplete as we still await the bioequivalence studies and informed consent for the registration trials.

However, using bioequivalence as a “bridge” between two biologics contradicts one of the basic rules of adjuvanted vaccinology.

The 2008 US National Vaccine Advisory Committee (NVAC) report Dose Optimisation Strategies for Vaccines: The Role of Adjuvants and New Technologies states: “Antigen/adjuvant combination is vaccine specific and no data are available currently that would allow an extrapolation to another antigen or even to the same formulation given by a different route” (Dekker, Gordon, & Klein, 2008). This view was still held in 2013, when the WHO warned that “an adjuvant-mediated enhancement of the immune response to one vaccine antigen, as a rule, cannot be extrapolated to the enhancement of the immune response to another antigen”

(WHO, 2013, p. 20). Second, in its 2007 guideline, the WHO stated that “because of the inherent variability in the assay systems used to measure immune responses, it is unwise to directly compare results from different studies” (WHO, 2007).

However, as we will see in future posts, these rules have seemingly been watered down.

All avian influenza vaccines contain slightly different avian antigens plus the adjuvant MF59, as we showed in tabular form in our post. None of them cross react as the summary of product characteristics reports.

Ruminations of Old Geezers - More on a Confusing Read

All have been assessed using surrogate outcomes (antibody responses), the significance of which is unknown. They are all part of a far bigger effort to improve pandemic preparedness involving WHO and the usual suspects.

We will continue asking if this is the correct use of scarce public funds. We estimated 2024 expenditure on these “just in case” vaccines was around £49.5 million to sit on the shelf. Another tranche of cash will be required to replace it when it expires.

We are still confused about the role of the vaccines and have noted some discrepancies,

Tom is now on first name terms with the MHRA Central Freedom of Information Team’s xxxxxxxxxxxxxxxxxxxxxxxx@xxxxxxxxxxxxxx.xxx, who now sign responses with “Yours Sincerely.” Keep following us in the subsequent efforts to get to the bottom of this saga.

Two angry old taxpayers on first name terms wrote this post.

Readings

Dekker, C., Gordon, L., & Klein, J. (2008). Dose optimisation strategies for vaccines: The role of adjuvants and new technologies. Report (with recommendations)

approved at the 6 February 2008 American National Vaccine Advisory Committee (NVAC) Meeting. Washington, DC: Health and Human Services.

World Health Organization (WHO), Expert Committee on Biological Standardization. (2007). Guidelines on regulatory preparedness for human pandemic influenza vaccines (Adopted 2007). Annex 2 to the Fifty-eighth report. Retrieved from https://www.who.int/biologicals/vaccines/Annex_2_WHO_TRS_963-3.pdf