The Avian Influenza Trilogy

The procured vaccine

We are now in the third and last part of the trilogy. Here we try to answer the question of what the UKHSA purchased with our money and what its properties are.

We preface this post by stating that answering the question should be the UKHSA’s job. Not the two old geezers’.

Before Christmas, we had a first go at identifying the product:

The H5N1 vaccine UKHSA purchased from CSL/Sequirus LTD

And the likelihood of viral transmission:

The UKHSA review of influenza H5N1 Incubation and Infectiousness

This is the content of the vaccine according to the EMA (remember, in the EU it’s called Incellipan):

Incellipan was licensed in the EU on 9 October 2023. The FDA licensed its US counterpart (Audenz) on 24 April 2024.

We asked the UKHSA about the vaccine's performance and benefit-risk profile. The UKHSA’s answer was we don’t know. We only issued the tender and paid for the stuff; we are only here for the beer; ask the MHRA. We are waiting for an answer, if you recall.

A third answer to our questions to the UKHSA about the bird flu vaccine

So, who SHOULD get Incellipan if we have a zoonotic pandemic?

• Adults aged 18 or more

  Who SHOULD NOT get it?

• Youngsters below the age of 18

• Those who have a history of allergy to any of its components.

• Those with a history of bleeding

• Probably pregnant women or in reproductive age

• Probably the elderly, especially with pre-existing medical conditions and/or immune problems

Also, take care if you work with machinery or drive. In light of the Pandemrix story, this is a very worrying warning.

The effectiveness (capacity to prevent infection and transmission) of Incellipan is unknown, but it is inferred from its H5N1 and H1N1 stable mates, and so are the harms.

The correlates of protection, as usual, are antibody rises following immunisation, which is widely not understood. The duration of protection is unknown, and we have concluded that the title “H5” of the UKSA’s tender is due to the assumption that Incellipan will protect against H5N1: take two and (you) pay for one. Hence the “whatnot” title; now we get it!

Analogy logic is a very hazardous practice when dealing with biologics, as the Pandemrix story has shown. It is especially hazardous when generalising from a product that hasn’t been field-tested for effectiveness.

Why would mortality data by vaccine exposure be withheld from Parliament and Jane/Joe Public?

The alchemy of biologics, especially vaccines, is usually fully played out only when you vaccinate very many people.

We have many worries about what we read. The list of potential harms is one, but it refers to other influenza vaccines, not Incellipan. For Incellipan, we simply do not know.

One of the other aspects that we find worrying is the very high rate of deaths in the “analogous” H5N1c intervention arms. Our reader Bryan Tookey commented on this, and it is worth clicking on the link to read what he has to say.

To finish, a note on the use of antibody responses as a correlate of protection in vaccine trials (especially influenza). We have covered this topic many times, for example, in the MHRA papers series.

As influenza viruses mutate and procurement takes a long time (6-9 months), registration has to be based on a forecast of effectiveness, essentially a surrogate. Unkindly, we could call it a vaccine against yesterday’s virus.

 There is nothing manufacturers and regulators can do about that; it’s called microbiology.

However, the dubious significance of antibodies as correlates of protection has been known for decades, and nothing has been done to narrow the precision of the forecast effectiveness.

In addition, the public has not been told this fundamental fact, which explains why influenza vaccine coverage bears little relationship to field protection. The “safe and effective” mantra still rules supreme.

So, what do you make of the trilogy?

This post was written by two old geezers who think Parliament should urgently oversee the H5 vaccine contracts and similar ones using experts not tied to the UKHSA, any branch of government, or pharma. To be clear, the two old geezers recuse themselves.