Zealots in Zealand, Tragedy in Denmark

This post by Peter Selley flags a growing menace.

Denmark has a tradition of public trust. Some say it stems from the rapid introduction of Jenner’s smallpox vaccination in the early 1800s. In just seven years, smallpox was eradicated from Copenhagen. Fast forward two centuries, half a million Danes are taking part in a trial of Pfizer’s Abrysvo RSV vaccine – DAN-RSV. RSV can cause occasionally severe chest infections in the young and the old – with no problems in between.

The Gold Standard for a clinical trial is that it should be a randomized controlled trial (RCT). DAN-RSV is an “investigator-sponsored, pragmatic, open-label, individually randomized clinical trial”.

Something’s Rotten…

Of course it was not “investigator-sponsored”. According to the study protocol, Pfizer coughed up $22m to reward the Danish researchers. And donated 345,000 free vaccines for use in the trial.

This vaccine’s main ingredient is the PreF protein of the RSV-A and RSV-B Respiratory Syncytial Viruses, in equal amounts.

Vaccines against RSV have already been extensively promoted to paediatricians and respiratory physicians. But Pfizer have identified a gap in the market. Cardiology. An awareness campaign was needed for heart specialists, whose patients have an unmet need for Abrysvo. This trial would put RSV on cardiologists’ horizons.

This ongoing massive trial and some of its first outcomes were briefly covered last year in Ground Control to RSV – RSVP and in the comments.

The study started in winter 2024, originally comparing outcomes in >130,000 adults aged >60, half of whom were given the RSVpreF vaccine. Why Denmark? Individual-level “raw” participant data stemming from Danish health registries cannot be shared?

The results have been presented at the European Society of Cardiology (ESC) Congresses in 2025 and 2026. They were published behind a paywall by the NEJM to coincide with the congresses. [Pfizer of course can afford, if it wants to, to make any published journal article open-access – i.e. free for all to read. But it chose not to. The results may explain why. The Danish team has kindly uploaded one of the NEJM articles.]

ESC is an annual beanfeast, this year attracting nearly 34,000 healthcare professionals and more than 230 journalists to a four-day event in Munich “sponsored” by the pharmaceutical industry to the tune of £14m including £400,000 from Pfizer.

ESC is where international cardiac guidelines are drawn up.

DAN-RSV 2025

The volunteers were randomised to two groups, which were claimed to be well matched, but the (unvaccinated) control group had 20% more Serious Adverse Events (SAEs) in the first six weeks. Could the vaccine have protected recipients from injury- and cancer-related serious adverse events – SAEs?

An interim analysis in August 2025 suggested that among adults 60 years of age or older, the vaccine reduced the incidence of hospitalisation for RSV-related respiratory tract disease as compared to control. While hospital admission with confirmed RSV was reduced, there was no overall benefit in terms of mortality. There were more deaths in the vaccinated group.

But RSV vaccine trials concentrate on the effect on RSV rather than overall outcomes and an analysis published in JAMA showed vaccine efficiency of 9.9% for reducing all-cause cardiorespiratory hospitalisations.

Unfortunately, however, RSV hospitalisation rates during the 2024/2025 season weren’t going to have people racing out to get the vaccine – 21 admissions in over 131,000 participants.

Scandi Noir

Pfizer took some desperate steps. It altered the protocol. The planned sample size was increased for the next season from 130,000 to 690,000 participants. They did this by reducing the age limit from 60 to 18 – people under 60 rarely get significant RSV. They opened recruitment to participants from Galicia in Spain.  And the end-date for the trial has been postponed to August 2028 – pushing a definitive publication into the long grass.

Federico Martinón-Torres – a pediatrician? – was pulled in to coordinate the Spanish end. He is from Santiago de Compostela and has multiple close links to Pharma – especially Sanofi the manufacturer of nirsevimab, an RSV monoclonal antibody for immunising babies.

DAN-RSV 2026

Two sets of results were presented at the recent Munich ESC congress, and simultaneously published in a new paywalled journal called NEJM-Evidence.

The first was another interim analysis which included data from the extra (Spanish and younger) participants. The second was a report on the “durability” of the vaccine in the original smaller cohort of Danes.

Pfizer will have been overjoyed with their decision to include participants from Galicia as, remarkably, last winter there were no cases of RSV in the 24,599 vaccinated Spanish participants, compared with 8 in the 24,686 unvaccinated controls. In Denmark a quarter of the RSV cases were in the vaccinated group.

The take-home message for ESC delegates was that the vaccine reduced the incidence of RSV-related respiratory hospitalisations from 0.55 to 0.16 events per 1000 person-years. This corresponds to a vaccine effectiveness of 70.3%. Must be good.

The use of “events per 1000 person-years” is misleading. The numbers of events in the two groups were 19/255,574 and 64/255,961 which gives a conventional Absolute Rate Reduction (ARR) of 0.018%. By comparison Pfizer’s BNT162b2 covid vaccine claimed an ARR of 0.7%. With Abrysvo, 5691 people would need to be vaccinated to prevent one RSV-related hospitalisation. The only people likely to profit from this are Pfizer.

Flatliner

This image from NEJM Evidence demonstrates the cumulative incidence of hospitalisation for RSV-related respiratory tract disease in the two groups.

In the case of all-cause respiratory hospitalisations, there were 11.16 events per 1000 person-years in the RSVpreF vaccine group and 12.01 events in the no-vaccine group, corresponding to a vaccine effectiveness of just 7.1%

Five vaccine recipients developed Guillain–Barré syndrome, a serious rapid-onset neurological problem, in the first six weeks after vaccination.

Six of the 57 “authors” of the paper are Pfizer employees who “made substantial contributions to the conceptualization and design of the study”.

The second report was a follow-up of the original Danish cohort, vaccinated in winter 2024-25. The results below show vaccine efficacy has decreased by a third (from 83.3% to 56.2%). More vaccinated Danes died than their unvaccinated compatriots.

To Jab or not to Jab

Two highly respected Drug Information Bulletins Prescrire (France} and MedCheck (Japan) have recommended against RSV vaccination of older folk.

But RSV vaccines are being incorporated into vaccination schedules in many countries. In the UK Abrysvo is recommended for everyone over 75, plus all adult residents in care homes for older adults and people aged 65 to 74 years who are immunosuppressed or who have chronic respiratory disease.

Pfizer are bound to suggest that the solution for declining vaccine efficiency from one RSV season to the next will be annual Abrysvo shots – as with flu shots.

Despite the evidence, it is probably just a matter of time before patients with or at risk of heart disease will be conscripted.  A recent high powered British Journal of General Practice article entitled Missingness cited all the saints of sensible medicine like Julian Tudor Hart and his inverse care law – that the people least in need to monitoring are those who turn up regularly to the medical clinic and those most in need are those doctors never get to see – as it made the case for an ABCV of cardiac prevention.

An ABC of cardiac prevention has been around for decades and is easily guessed – B is for blood pressure, C for cholesterol.  A might be slightly harder – Atrial Fibrillation. But what on earth is V?  It’s mentioned in the paper as though it too is as obvious as the A, B and C.  It will need a reach out to men and to deprived communities. V is RSV vaccination, which the authors of the paper portray as now accepted cardiological wisdom.

To be or not to be jabbed: that’s the question:
Whether ’tis nobler in the mind to suffer
The jabs of Pfizer’s outrageous fortune,
Or to take arms against a sea of troubles,
And by opposing end them?