An illustration of the respiratory syncytial virus (RSV) in cross-section landing on a respiratory endothelial cell in humans. A nuclear protein core capped by large L proteins is depicted with single-stranded RNA (colored purple). The virion exterior is populated by F and G proteins, while its interior is lined by M2-1 and M proteins. G proteins are shown as tangled tubular structures, and F proteins are represented as structures resembling drumsticks.
Credit: NIAID CC BY 2.0 Human Respiratory Syncytial Virus (RSV) (52501736052).jpg
What Have We Here
Over the last 3 years RxISK.org and DavidHealy.org have run a series of RSV (Respiratory Syncytial Virus) posts, listed below. We (Peter Selley and David Healy) got into this thanks to some marvellous and continuing sleuthing by Peter Selley.
Yellow and Other Virus and Vaccine Perils — August 8, 2022
A Shot in the Dark for Pregnant People — May 7, 2023
Women, Pregnancy, and Clinical Trials — June 2, 2023
Another Brick in the Wall — September 11, 2023
Women and Children First: The RSV Iceberg — November 16, 2023
Coming Clean on Neonatal Deaths — December 12, 2023
For Every Matter under Heaven, there is a Season — March 18, 2024
The Once and Future Immunity — April 14, 2024
It is Hard for Thee to Kick Against the Pricks — October 21, 2024
The Respiratory Syncytial Virus Challenge — February 16, 2025
The Miracle of Artificial Intelligence — August 10, 2025
From Just Say NO to Getting to YES — September 1, 2025
The Miracle of Articial Intelligence brings RSV in by the back door. Just Say develops the role A.I. is increasingly likely to play in the RSV story.
The State of Play
The licenced or en route to being products licensed by FDA for preventing respiratory syncytial virus (RSV) associated disease in infants, or the elderly. These are approves as Just Say No will illustrate on a specific effect on the RSV virus rather than on the basis of overall benefits to mothers, fetuses, infants or the elderly.
- Abrysvo® maternal – unsettled concerns the consequences for mothers and babies
- Arexvy® maternal – withdrawn because of consequences in mothers and babies but licensed for older folk.
- mRESVIA® maternal (mRNA) – trials in progress
- mRESVIA® infants (mRNA) – withdrawn as linked to severe respiratory illness
- Beyfortus® infants – uncertainty about safety
- Enflonsia® infants – uncertainty about safety
- Synagis® (palivizumab) infants – the first monoclonal for RSV, sidelined because no longer a money-maker.
Known Unknowns
Neither we nor anyone else seems to know:
- If these immunisations reduce illnesses, and deaths from all conditions?
- If massive levels of antibodies in babies interfere with RSV testing from nasal swabs?
- How many immunised babies are hospitalized for chest infections in their second RSV season?
- Whether 105 mg of clesrovimab is a dangerously big dose for a preterm baby?
- What causes Vaccine Associated Enhance Respiratory Disease (VAERD) in RSV-naïve babies?
- Whether we should worry about antidrug antibodies to these monoclonals?
- Whether we should worry about the development of resistant viruses?
- Whether the RSV campaign has interfered with uptake of more important maternal and child vaccines?
- Whether immunisation is as safe or effective as immunity from a natural infection allied to maternally derived immunity?
- Why these immunisation programs were introduced globally so rapidly?
- How rapid “Fast Track” assessments by regulators were justified?
RSVP
We are interested to hear from anyone who can shed any light on any of the above.
That is a load of very interesting questions.
Why these immunisation programs were introduced globally so rapidly?
CDC – RSV
https://www.cdc.gov/rsv/index.html
As Robert Kennedy Jr. is pulling apart the CDC, by ousting new director, Susan Moneraz, and appointing a new CDC Acting Director, Jim O’Neill.
As Robert Malone ,has said previously, he is blaming the CDC for withholding information, which only gave them a day to consider the information before the vote. He voted in favour. He wrote on his Malone news that he would never trust the CDC again.
Retsef Levi knew better, he voted against.
There are literally reams of media, advocating RSV:
https://www.gov.uk/government/publications/respiratory-syncytial-virus-rsv-symptoms-transmission-prevention-treatment/respiratory-syncytial-virus-rsv-symptoms-transmission-prevention-treatment
Let’s choose Ireland:
https://her.ie/health/hse-extends-rsv-winter-programme-644898
‘Not only will the RSV programme help protect infants, but it also lifts immense pressure from the healthcare service during the already busy winter months.’
‘a jab into the baby’s leg.’
RSV getting a ‘leg-up’ from all and sundry.
Ground Control to Major Tom
Your circuit’s dead, there’s something wrong
If Major Tom had made it back to Earth he would probably been eligible for RSV vaccination. Previously in this blog we haven’t discussed the use of RSV vaccines (Abrysvo, Arexvy and mRESVIA) in the elderly.
By happy coincidence two papers were simultaneously published about this – one in NEJM the other in JAMA. They used the same data and were written by the same team. The DAN-RSV Trial, comparing vaccine to no vaccine, was sponsored by Pfizer although no Ghost Authors are acknowledged. The trial was conducted by the European LifeCare Group: motto – “Nothing saves lives like vaccinations” which is probably true.
These papers claim that RSV vaccines prevent cardiovascular hospitalizations and reduce the incidence of hospitalization for RSV-related respiratory tract disease in older adults.
The only problem is that more vaccinated participants err… died.
Whilst all-cause hospitalisations were reduced by 2%, all-cause deaths increased by 21.7%.
For those with preexisting cardiovascular disease 74/14377 vaccinated participants died, compared to 47/14285 in the group that were left alone – an increase of 56.5% (133.5 – 8.5).
These data can be found in the on-line supplements.
Can you hear me, Major Tom?
It’s quite possible there isn’t a note re ghostwriters in small print at the end because A.I. has drafted the manuscript – as Albert Bourla said in his autobiography back in 2021 would be happening very soon.
The Supplement is well worth looking at in addition to reading. Its full of bold print positive results for hospitalizations linked to confirmed RSV lower tract respiratory infections – all of which convincingly make the case for the vaccine. Then on the last page, in much smaller print and right down at the bottom of a set of small print mostly positive findings are the findings on all cause hospitalizations – no benefit – and all cause deaths – meet God sooner rather than later.
It’s too late for Jorge Mario Bergoglio (Pope Francis) but perhaps Major Tom should remain a Doubting Thomas?
David
The JAMA advertorial is “open access” but the NEJM one is behind a paywall (although you can sign up to have access to 2 articles a month for free).
https://jamanetwork.com/journals/jama/fullarticle/2838491
https://www.nejm.org/doi/full/10.1056/NEJMoa2509810
The small print at the end of the JAMA article does not list ghosts. In this case, there may be no ghosts or medical writers although there is a long list of Pfizer employees linked to the study. The small print says Pfizer Inc made no contribution to the running or analyses or interpretation of the data but Pfizer Inc is legally a person distinct from the Pfizer people listed below.
What is interesting is there was A.I. input into the cardiac assessments from US2.AI – a company that specialises in this to which one of the authors Dr Solomon has links.
Author Affiliations:
Department of Cardiology, Copenhagen University Hospital–Herlev andGentofte, Copenhagen, Denmark (Lassen, Johansen, Christensen, Skaarup, Modin, A. M. R. Jensen, Dons, Bernholm, Davidovski, Duus, Ottosen, Nielsen, Borchsenius, Espersen, Köse,Fussing, Pareek, Biering-Sørensen);
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark (Lassen, Johansen, Christensen, Skaarup, Modin, A. M. R. Jensen, Dons, Bernholm, Davidovski, Duus,Ottosen, Nielsen, Borchsenius, Espersen, Köse, Fussing, Pareek, Biering-Sørensen);
Pfizer Inc, New York, New York (Aliabadi, Gessner, Schwarz, Gonzalez, Skovdal, Zhang, Begier);
Cardiovascular Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts (Claggett, Solomon);
Department of Clinical Medicine–Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark (C. S. Larsen);
European LifeCare Group, Søborg, Denmark (C. S. Larsen);
Research Unit for Infectious Diseases, Odense University Hospital, Odense, Denmark (L. Larsen);
Department of Infectious Diseases, Zealand University Hospital, Roskilde, Denmark (Wiese);
Department of Infectious Diseases, Aalborg University Hospital, Aalborg, Denmark (Dalager-Pedersen);
Department of Clinical Medicine, Aalborg University Hospital, Aalborg, Denmark (Dalager-Pedersen);
Department of Cardiology, Zealand University Hospital Roskilde, Roskilde, Denmark (Lindholm);
Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark (Køber, J. U. S. Jensen);
Department of Cardiology, Copenhagen University Hospital–Rigshospitalet, Copenhagen, Denmark (Køber, Biering-Sørensen);
Respiratory Medicine Section, Department of Medicine, Copenhagen University
Hospital–Herlev and Gentofte, Copenhagen, Denmark (J. U. S. Jensen);
Statens Serum Institut, Copenhagen, Denmark (Martel);
Pfizer Canada, Kirkland, Quebec, Canada (Moulton);
Steno Diabetes Center Copenhagen, Copenhagen, Denmark (Biering-Sørensen).
Author Contributions: Drs Lassen and Biering-Sørensen had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Lassen, Johansen, Christensen, Aliabadi, Skaarup, Davidovski, Köse, Solomon, Martel, Gessner, Schwarz, Gonzalez, Skovdal, Zhang, Begier, Biering-Sørensen.
Acquisition, analysis, or interpretation of data: Lassen, Johansen, Aliabadi, Skaarup, Modin, Claggett, C. Larsen, L. Larsen, Wiese, Dalager-Pedersen, Lindholm, A. Jensen, Dons, Bernholm, Davidovski, Duus, Ottosen, Nielsen, Borchsenius, Espersen, Köse, Fussing, Pareek, Køber, J. Jensen, Gessner, Moulton, Begier, Biering-Sørensen.
Drafting of the manuscript: Lassen, Moulton, Biering-Sørensen.
Critical review of the manuscript for important intellectual content: Johansen, Christensen, Aliabadi, Skaarup, Modin, Claggett, C. Larsen, L. Larsen, Wiese, Dalager-Pedersen, Lindholm, A. Jensen, Dons, Bernholm, Davidovski, Duus, Ottosen, Nielsen, Borchsenius, Espersen, Köse, Fussing, Pareek, Køber, Solomon, J. Jensen, Martel, Gessner, Schwarz, Gonzalez, Skovdal, Moulton, Zhang, Begier, Biering-Sørensen.
Statistical analysis: Lassen, Modin, Moulton, Zhang, Biering-Sørensen.
Obtained funding: Christensen, Gessner, Begier, Biering-Sørensen.
Administrative, technical, or material support: Christensen, L. Larsen, Dalager-Pedersen, A. Jensen, Dons, Bernholm, Davidovski, Duus, Nielsen, Borchsenius, Fussing, Martel, Schwarz, Begier, Biering-Sørensen.
Supervision: Johansen, Aliabadi, Claggett, C. Larsen, Dalager-Pedersen, Lindholm, Pareek, Køber, Solomon, J. Jensen, Gessner, Schwarz, Gonzalez, Skovdal, Biering-Sørensen.
Conflict of Interest Disclosures: Dr Aliabadi reported being an employee of Pfizer Inc and owning Pfizer stock.
Dr Skaarup reported receipt of personal fees for advisory board membership from Sanofi and travel support for congress participation from AstraZeneca.
Dr Claggett reported receipt of personal fees for consulting from Alnylam, Cardior, Cardurion, Cytokinetics, CVRx, Intellia, Rocket, Lilly, and Alexion.
Dr Pareek reported receipt of personal fees for advisory board membership and/or speakerfees from AstraZeneca, Bayer, Boehringer Ingelheim, Janssen-Cilag, and Novo Nordisk and grants from the Danish Cardiovascular Academy and the Danish Heart Foundation.
Dr Køber reported receipt of speaker honoraria from Novo Nordisk, Novartis, AstraZeneca, and Boehringer Ingelheim.
Dr Solomon reported receipt of grants to his institution from Alexion, Alnylam, Applied Therapeutics, AstraZeneca, Bellerophon, Bayer, BMS, Boston Scientific, Cytokinetics, Edgewise, Eidos/BridgeBio, Gossamer, GSK, Ionis, Lilly, the National Institutes of Health/National Heart, Lung, and Blood Institute, Novartis, Novo Nordisk, Respicardia, Sanofi Pasteur, Tenaya, Theracos, and US2.AI and personal fees from Abbott, Action, Akros, Alexion, Alnylam, Amgen, Arena, AskBio, AstraZeneca, Bayer, BMS, BridgeBio, Cardior, Cardurion, Corvia, Cytokinetics, GSK, Intellia, Lilly, Novartis, Roche, Theracos, Quantum Genomics, Tenaya, Sanofi Pasteur, Dinaqor, Tremeau, CellProThera, Moderna, American Regent, Sarepta, Lexicon, Anacardio, Akros, Valo, Synhale, and Recordati.
Dr Gessner, Dr Schwarz, Ms Gonzalez, Ms Skovdal, Dr Moulton, Ms Zhang, and Dr Begier reported being employees of Pfizer Inc and owning Pfizer stock.
Dr Biering-Sørensen reported receipt of personal fees for consulting and/or lectures from Sanofi Pasteur, GSK, Novo Nordisk, IQVIA, Parexel, Amgen, CSL Seqirus, Bayer, Novartis, and GE Healthcare and grants from Sanofi Pasteur, Pfizer, AstraZeneca, Boston Scientific, GE Healthcare, Novartis, Novo Nordisk, Bayer, and AstraZeneca.
No other disclosures were reported.
Funding/Support: DAN-RSV was funded by Pfizer Inc.
Role of the Funder/Sponsor: In this collaboration between the Center for Translational Cardiology and Pragmatic Randomized Trials (CTCPR) at the Department of Cardiology, Copenhagen University Hospital–Herlev and Gentofte, University of Copenhagen, Denmark, and the private vaccine provider Danske Lægers Vaccinations Service/ European LifeCare Group, the CTCPR acted as trial sponsor and the central trial coordination site and was responsible for the overall study design, conduct, registry-based recruitment and data collection, and safety monitoring.
Pfizer Inc participated in the design of the study and in the development of the protocol and statistical analysis plan. Pfizer Inc had no role in the conduct of the study; collection, management, analysis, or interpretation of the data; preparation of the manuscript; or decision to submit the manuscript for publication. Pfizer Inc was involved in reviewing and approving the final version of the manuscript.
Meeting Presentation: Presented at ESC Congress 2025; August 30, 2025; Madrid, Spain.
Data Sharing Statement: See Supplement 4.
Additional Contributions: We thank all personnel at European LifeCare Group for collaborating and assisting with study procedures.
I now realise that articles using data from this paper-mill were simultaneously published in two other journals, also on 30 August.
Commencing countdown:
We’re now up to four.
Is this a record? (Geddit?)
https://www.jacc.org/doi/10.1016/j.jacc.2025.08.023
https://academic.oup.com/eurheartj/advance-article/doi/10.1093/eurheartj/ehaf679/8244098?searchresult=1
Engines on
(Four, three, two) Check ignition
(One) And may God’s love
(Lift-off) Be with you
For some strange reason the name Abrysvo® is nowhere to be seen in any of these papers, which instead refer to RSVpreF vaccine.
Why would Pfizer not want the publicity?
Could it be anything to do with the higher all-cause death rate in the over 60’s?
It is not strange that Abrysvo is not mentioned. As a video in tomorrow’s post will show, the big deal for Pfizer is to occupy the only RSV vaccine ground. You want a vaccine for RSV – you almost have no option now that even Astra-Zeneca are calling Beyfortus a drug. This war is only starting.
D
Single Dose of RSV Vaccine Demonstrates Long-Term Effectiveness in Older Adults
https://themunicheye.com/single-dose-rsv-vaccine-effectiveness-older-adults-26014
‘While the study affirms the effectiveness of the vaccine, it also notes a gradual decline in its protective benefits over time. Self remarked that the diminishing efficacy suggests the possibility of needing booster doses to sustain protection against RSV in the long term. Monitoring the durability of vaccine effectiveness will be crucial for informing future vaccination strategies.’
Here we go, ‘the ‘Booster’ strategy..
You mean the make money approach?
D