When a jab doesn’t work, just change the name

In November 2009 an NHS Wales Swine Flu Pandemic Weekly Report stated openly that, in preparing for a pandemic, ‘appropriate trials to assess the safety and the immune responses’ were carried out ‘on vaccines very similar to the swine flu vaccine’ (my italics). In those days, there was at least a modicum of informed consent when a ‘bait and switch’ occurred, as it was publicly acknowledged that the authorised vaccines were only ‘similar’ to the tested ones. Not so, however, when it came to Matt Hancock and the MHRA’s Pfizer/BioNTech vaccine approval.

And it’s the case again today. The idea of testing one version of a vaccine and jabbing another never went away.  On October 10, the FDA Vaccine and Related Biological Products Advisory Committee (VRBPAC) met to discuss the ‘strain change process’ for the allegedly highly pathogenic H5 bird flu preparedness, in fact one of the most overhyped viruses in existence.

Jerry P Weir, the director of the FDA’s Division of Viral Products and adviser to the World Health Organization (WHO) on influenza virus vaccines and vaccine standards, whose department helps select the strains included in annual seasonal influenza vaccines, told the committee that ‘we are all . . . doing everything we can do to be as prepared as possible to shorten the time needed to get a vaccine to market‘. This means they’re testing similar ones again so that updated versions can then be made and rolled out quickly on the assumption they are equally effective.

As non-mRNA vaccine manufacture typically takes six months, manufacturers are told in February/March of each year which seasonal influenza strains to target for the next winter flu season. When these seasonal vaccines miss a strain, pandemic flu vaccines are on standby to plug the gap. In fact a library of prototype pandemic influenza vaccines exists to address the ‘rapidly evolving’ bird flu menace which the VRBPAC committee was told entered North America in 2021.

So far in this year’s winter flu hysteria season, the allegedly ‘highly pathogenic’ bird flu has been a damp squib. In the US, the year-to-date tally is a paltry 20 cases of human bird flu, yet the vaccines will be ready to roll when it’s turned into the next scariant and allegedly spreading asymptomatically. Fifty cases is the harbinger of doom, according to Professor Neil Ferguson’s infamous 2006 modelling of influenza pandemic prevention strategies, and should signal the start of mitigation measures to flatten the curve. It didn’t work for SARS-CoV-2, but any expectations that authorities have learned lessons leading to a revision of current dogma remain worryingly low.

Vaccine manufacturers are poised to cash in from government advance purchase agreements for hundreds of millions of doses should an influenza pandemic be declared by the WHO. Standing at the ready to turn on the pharma profit spigots once again are public health authorities, including the US Center for the Biomedical Advanced Research and Development Authority (BARDA) and the EU Health Emergency Preparedness and Response Authority (HERA). Funny so many are named authorities which, far from inspiring confidence in their pronouncements, has increasingly sinister overtones of enforced obedience to their diktats.

As well as the questionable ‘need’ for these vaccines, their effectiveness once again is doubtful.  A January 2024 Chinese review of real-world effectiveness of seasonal flu vaccines concluded it was ‘moderate’, varied substantially by demographic and by strain, and noted that the products had to be continuously reformulated due to the ‘dynamic and evolving nature of the virus’. Pandemic influenza vaccines, however, are reformulations for strains missing from these seasonal vaccines, yet the FDA says, ‘effectiveness [is] inferred from seasonal vaccine’. This is doublespeak for ‘they are equally useless but we’ll license them anyway because public health authorities are squawking about the sky falling in’. If they were financial products they’d carry a disclaimer saying ‘past performance is no guarantee of future results’; only with vaccines the often-dismal  past performance is a surefire guarantee of future results.

In July 2024, BARDA announced a $174million award to Moderna to develop mRNA pandemic influenza vaccines against H9N7 bird flu. These are not however currently part of US preparedness plans which are based on H5 vaccine candidates from CSL Seqirus, Sanofi and GSK for whom BARDA is funding phase 3 trials. 

The GSK vaccine being trialled is Adjupanrix which, as the European Medicines Agency (EMA) website shows, is a reformulated and rebranded version of Pandemrix, the mock-up vaccine deployed in 2009 and 2010 to six million people in Britain against H1N1 swine flu, and which had a higher level of adverse events than other H1N1 vaccines. Its death knell was the link identified in 2010 with an increase in the chronic neurological disorder narcolepsy, which afflicted dozens of children. The jab was withdrawn after doctors noticed a sharp rise in narcolepsy, which can cause sufferers to fall asleep suddenly at any time during any activity, among those who received it.

The link between the vaccine and narcolepsy was finally acknowledged by UK courts in 2015. As recently as December 2022, a Helsinki court ordered compensation to be paid to a group of Finnish patients who were found to have narcolepsy as a side effect of Pandemrix. Due to the bad publicity over narcolepsy, the demand for Pandemrix H1N1 collapsed and GSK let its marketing authorisation expire in August 2015.

As it turns out, cash cows die hard. Pandemrix had already been repurposed. Beginning in 2012, GSK applied to the EMA for variations to the original 2009 marketing authorisation including changing the name to Prepandrix, and reformulating and testing it for use against H5N1 (Vietnam-strain) bird flu. In December 2015, four months after the authorisation for the H1N1 version lapsed, the marketing authorisation was varied indicating it for use against H5N1. It is now called Adjupanrix.

Each version of the GSK vaccine contains AS03, an emulsified fish-oil (squalene) adjuvant used to stimulate a ‘stronger and broader’ immune response. The EMA notes that there is a risk that this adjuvant or another common ingredient is the cause of narcolepsy.

In April 2023, the UK Health Security Agency (UKHSA) published guidance on its website which it says was issued to support the spring and autumn Covid-19 vaccination campaigns. This guidance downplayed the risk of narcolepsy from Pandemrix, saying it was rare. Ironically a 2015 presentation by Dr June Raine, the outgoing head of the Medicines and Healthcare products Regulatory Agency (MHRA), who was then its head of pharmacovigilance, listed narcolepsy as a ‘landmark’ safety signal for Pandemrix. Yet nine years later the UK Health Security Agency (UKHSA) told the public the reason for the link between Pandemrix and narcolepsy was unclear. Instead of flagging the adjuvant up as being the potential link with narcolepsy as the EMA does, it said the leading theory was that narcolepsy was probably caused by the H1N1 influenza antigen. In propping up the adjuvant it seemingly misses another glaringly obvious problem: if the antigen was causing the Pandemrix safety problem, how can pre-approved mock-ups that swap in new antigens ever be assumed to be safe?

On October 11 2024, UKHSA updated its website to say that the guidance had been withdrawn, but offered no explanation. In fact it was withdrawn in response to a public health misinformation maladministration complaint from a member of the public that UKHSA was misrepresenting the narcolepsy risk for children by stating only the rate in adults: one case per 175,000 Pandemrix doses. But the majority of harm caused by Pandemrix was in under-20s for whom the published incidence rate for narcolepsy following vaccination is around 1 in 30,000. The complainant also took issue with ‘victim gaslighting’ as the guidance was suggesting that narcolepsy victims of all ages were genetically susceptible to harm, thus deflecting from the harm caused by the vaccine.

Responding, UKHSA excused itself by saying that the MHRA had supplied it with the information which was published specifically to support the introduction in 2023 of GSK’s Covid vaccine VidPrevtyn beta which uses the same AS03 adjuvant as Pandemrix. UKHSA said this vaccine was offered only to older adults and is no longer available. Apparently they meant to update the website earlier but the guidance remained public because of a broken link. The complainant is pursuing this maladministration matter further.

In July 2022, the European Commission’s Health Emergency Preparedness and Response Authority (HERA) signed a contract with GSK for 85 million doses of Adjupanrix, previously called Pandemic Influenza Vaccine H5N1, noting it is to be used only in the event that the WHO declares a pandemic. The European Commission says that the vaccine has been authorised under ‘exceptional circumstances’, those apparently being that ‘the vaccine is a mock-up and does not yet contain the strain of flu virus that is causing a pandemic [so] it has not been possible to obtain full information about the final pandemic vaccine’.

The UK government has announced signing an advance purchase agreement with Liverpool-based CSL Seqirus for unspecified millions of doses of its BARDA-funded pandemic vaccine which ‘will be tested, licensed, and approved and tailored to combat the specific pandemic flu strain identified at the time’.  Announcing the deal in September 2023, Dame Jenny Harries, the CEO of the UKHSA, said: ‘We have seen from past pandemic events, including Covid-19, that access to effective vaccines is vital to help save lives and minimise disruption to our lives and livelihoods.’

It seems odd that UKHSA has not announced an advance purchase agreement for GSK’s Adjupanrix. It couldn’t possibly be that the MHRA is doing a little more enabling, could it? Perhaps the limited deployment in 2023 of VidPrevtyn Beta, which GSK developed jointly with Sanofi with funding from US Department of Defense and BARDA, was a real-world test to see on the quiet if the adjuvant causes narcolepsy.