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- Arexvy® maternal – withdrawn because of consequences in mothers and babies but licensed for older folk.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- mRESVIA® infants (mRNA) – withdrawn as linked to severe respiratory illness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.
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