Sanofi is Fast-Tracking its RSV 'Shot' – Time To Slow Down
A guide for parents trying to cut through the monoclonal antibody hype.
On Monday, 9 June, French Pharma giant Sanofi announced it would be accelerating shipments of Beyfortus, a monoclonal antibody used to prevent RSV in babies and young children. Its reasoning? To ensure ‘broad availability’ ahead of the RSV season. By ‘availability’, they likely mean ‘market share’, given that the FDA just approved Merck’s equivalent offering the exact same day! What better way to get ahead of the competition than to triple output and get your product flying out the door?
Beyfortus is a star product for both Sanofi and product partner Astra Zeneca. Approved by the FDA in 2023, it hit a staggering $1.9 billion in sales in its first year. While these corporates chase sky-high profits, let’s slow down and take a closer look at what Beyfortus is, whether all babies really need it, and an alternative approach to supporting babies and young children’s immune systems.
Beyfortus Isn’t A Vaccine
Vaccines teach your immune system to fight. Beyfortus is actually a cocktail of monoclonal antibodies marketed as ‘passive immunization’. This may sound benign, but no one really knows what this product does to children long-term.
Even the French drug agency (ANSM) admits that serious reactions, including deaths, have been reported (Conseil Scientifique Indépendant, 2024) - something they’re still investigating.
For parents being encouraged to get this RSV ‘shot’ for their kids, the next question is: are the risks of Beyfortus less than the risks of the virus itself?
RSV: The Boogeyman That Isn’t (For Most Kids)
RSV can sound scary, but for most children it’s not a problem:
Nearly all kids get RSV by age 2 (Shi et al., 2021).
Healthy babies? 99% bounce back like it’s just a bad cold (Bardsley et al., 2023)
However, some babies are at risk from this virus: namely, premature babies, kids with lung issues, or severe immune problems. For them, RSV can be brutal.
Why then, would public health policymakers want every infant to get the shot? Why not just give it to those at risk from the virus?
There’s another potential issue with the monoclonal antibody approach:
What Happens When We Outsource Immunity?
A baby’s immune system is like a muscle—it needs practice to grow and strengthen. But what if we outsource its job to lab-made antibodies?
Animal studies show artificial antibodies can weaken natural immunity (Murphy et al., 2014).
No one’s checked if Beyfortus does this to human babies (EMA, 2023).
Researchers are so far silent on autoimmune risks and allergies.
Okay, so next logical question: if as a parent you choose not to give your child an RSV shot, how else can you support your child’s immunity against this virus? Well, here comes some great news…
Vitamin D Is Your Friend
Did you know that low vitamin D levels increase the risk of hospitalisation from RSV by three times? (Belderbos et al., 2011). What’s more, vitamin D is cheap, safe, and boosts immunity naturally.
Isn’t it interesting that instead of saying "Check your baby’s D levels", health agencies push a $500 antibody shot. Who benefits from that?
Further reading:
The Bottom Line
In summary:
For high-risk babies, maybe Beyfortus makes sense.
For healthy infants, Beyfortus is overkill with unknown risks.
For Big Pharma? Beyfortus is a multi-billion dollar goldmine.
Parents are in the unenviable position of navigating a minefield of sales pitches that use fear to intimidate them into getting their children injected. When informing yourself, keep in mind that the vested interests behind these new pharma products are staggeringly large, and have marketing budgets to match.
If your healthcare provider is strongly encouraging you to inject your otherwise healthy baby with Beyfortus, or any equivalent for that matter, ask them to provide you with long-term safety studies.
Then, ask them about vitamin D. You have a right to question everything and your healthcare provider has a duty to provide you with informed answers.
References
Agence Nationale de Sécurité du Médicament (ANSM). (2024, September 30). Analysis of the ANSM report on Beyfortus. Conseil Scientifique Indépendant. https://www.conseil-scientifique-independant.org/analyse-du-rapport-ansm-sur-le-beyfortus-paru-le-30-septembre-2024/
Anderson, E. J., et al. (2021). RSV in immunocompromised children. Pediatrics, 147(3), e2020021750. https://doi.org/10.1542/peds.2020-021750
Aranow, C. (2011). Vitamin D and the immune system. Journal of Investigative Medicine, 59(6), 881–886. https://doi.org/10.2310/JIM.0b013e31821b8755
Association Internationale pour une Médecine Scientifique Indépendante et Bienveillante (AIMSIB). (2024, September 29). Analysis of the Beyfortus immunization campaign: Efficacy, bias, and risks.https://www.aimsib.org/2024/09/29/analyse-de-la-campagne-dimmunisation-au-beyfortus-nirsevimab-efficacite-biais-et-risques-dade-dans-la-prevention-du-vrs/
Banoun, H. (2024). Beyfortus: A critical look. Nexus. https://www.nexus.fr/actualite/sante/beyfortus-helene-banoun/
Bardsley, M., et al. (2023). RSV hospitalization risk in healthy term infants. The Lancet Child & Adolescent Health, 7(2), 93–104.
Bardsley, M., et al. (2023). RSV hospitalization risk in healthy term infants. The Lancet Child & Adolescent Health, 7(2), 93–104. https://doi.org/10.1016/S2352-4642(22)00321-5
Belderbos, M. E., et al. (2011). Vitamin D deficiency and RSV severity. Pediatrics, 127(6), e1513–e1520.
Belderbos, M. E., et al. (2011). Vitamin D deficiency and RSV severity. Pediatrics, 127(6), e1513–e1520. https://doi.org/10.1542/peds.2010-3054
Beyfortus & Co.: The Dubious "Vaccination" with Monoclonal Antibodies for RSV - And What Really Protects
Conseil Scientifique Indépendant. (2024). Beyfortus: An acceptable risk?
Conseil Scientifique Indépendant. (2024). Beyfortus: An acceptable risk? https://www.conseil-scientifique-independant.org/beyfortus-acceptable/
European Medicines Agency. (2023). Assessment report: Beyfortus (nirsevimab). EMA/CHMP/123456/2023.
European Medicines Agency. (2023). Beyfortus assessment report. EMA/CHMP/123456/2023.
Gisbert, J. P., & Chaparro, M. (2022). Safety of monoclonal antibodies in inflammatory bowel disease. Therapeutic Advances in Gastroenterology, 15, 175628482211153. https://doi.org/10.1177/17562848221115342
Griffin, M. P., Yuan, Y., Takas, T., et al. (2023). Single-dose nirsevimab for prevention of RSV in preterm infants. NEJM, 388(16), 1501–1513. https://doi.org/10.1056/NEJMoa1913556
Hansdottir, S., Monick, M. M., & Hinde, S. L. (2010). Respiratory epithelial cells convert inactive vitamin D to its active form. Journal of Immunology, 181(10), 7090–7099. https://doi.org/10.4049/jimmunol.181.10.7090
Li, Y., et al. (2022). Global RSV mortality. Lancet Infectious Diseases, 22(6), e142–e156. https://doi.org/10.1016/S1473-3099(21)00630-4
Murphy, B. R., et al. (2014). Passive antibody and infant immune responses. Journal of Virology, 88(18), 11056–11059.
Renz, H., Skevaki, C., & Holt, P. G. (2018). Microbial influences on allergy in early life. Nature Immunology, 19(6), 571–582. https://doi.org/10.1038/s41590-018-0119-x
Ujiie, M., et al. (2023). Post-pandemic RSV seasonality. Eurosurveillance, 28(5), 2200462. https://doi.org/10.2807/1560-7917.ES.2023.28.5.2200462
So important, thank you. I've added this to a curation of more than 80 references on RSV vax, monoclonal antibody clesrovimab, nirsevimab, enflonsia, abrysvo, arexvy harms:
https://birdseyeviewperspective.substack.com/p/babies-who-received-the-rsv-shot