#Clesrovimab
🧵RFKJ and one of his ACIP picks, Robert Malone, appear to be getting ready to restrict the Respiratory Syncytial Virus (RSV) immunizations (nirsevimab and clesrovimab) saying there is a vast cover up of vaccine safety data.

As a pediatrician and CDC worker I have two questions for RFKJ about that:
September 5, 2025 at 9:40 PM
A study finding clesrovimab comparable to palivizumab in protecting at-risk infants in their first #RSV season was extended to demonstrate clesrovimab effective and well-tolerated when administered in their second season. #IDsky #Medsky
www.contagionlive.com/view/clesrov...
Clesrovimab Given in 1st and 2nd RSV Seasons for At-Risk Infants | Contagion Live
A study finding clesrovimab comparable to palivizumab in protecting at-risk infants in their first RSV season was extended to demonstrate clesrovimab effective and well-tolerated when administered in ...
www.contagionlive.com
October 3, 2026 at 12:01 PM
💉🧵PSA 🚨 We don’t know for sure but are very worried RFKJ’s ACIP is about to restrict access to RSV monoclonal immunization for babies (nirsevimab and clesrovimab). If your baby is eligible, get them vaccinated asap. RSV season starts late Oct-early Nov. See below for immunization recommendation info
September 12, 2025 at 10:07 PM
#DragiWebdo n°496 : Prescriptions de placebos, thromboses veineuses superficielles, clesrovimab/VRS, analogues du GLP-1, THM, acide tranexamique

www.medicalement-geek.com/2025/09/drag...
Dragi Webdo n°496 : Prescriptions de placebos, thromboses veineuses superficielles, clesrovimab/VRS, analogues du GLP-1, THM, acide tranexamique
Prescriptions de placebos, thromboses veineuses superficielles, clesrovimab/VRS, analogues du GLP-1, THM, acide tranexamique
www.medicalement-geek.com
September 22, 2025 at 7:51 PM
Because they couldn't adhere to the timetable, the vaccine panel will now pose questions about clesrovimab and the RSV vaccine/antibody presentations.
June 26, 2025 at 12:43 PM
Trial finds clesrovimab 60% effective in preventing RSV in infants

The efficacy for preventing medically attended RSV infections was 60.4%

www.cidrap.umn.edu/r...
September 22, 2025 at 9:20 PM
To clarify - nirsvimab and clesrovimab are passive monoclonal antibodies to prevent infection (usually in infants), while true RSV vaccines are subunit or mRNA vaccines that incite in vivo antibody production, usually in older people or during pregnancy. "Immunizations" can encompass both.
September 5, 2025 at 9:57 PM
Levi wants to know about the risks for clesrovimab. There is also an imbalance of deaths in absolute number in the phase 3 trials for clesrovimab (7 vs 3 for clesrovimab vs placebo). This is meaningless, however, given that it is... 2:1 randomized clesrovimab:placebo.
June 26, 2025 at 12:43 PM
clesrovimab
June 25, 2025 at 9:42 AM
Thanks for clarifying. Malone is going after nirsevimab and clesrovimab specifically which is why the thread focuses on babies. We’re not sure what they think of the RSV vaccine approved for pregnant women and older adults.
September 5, 2025 at 10:25 PM
New monoclonal antibody clesrovimab for RSV looks to be effective in preventing hospitalisation

Good news for infants and for paediatricians!

Looking forward to the full publication
Merck’s Clesrovimab (MK-1654), an Investigational Respiratory Syncytial Virus (RSV) Preventative Monoclonal Antibody, Significantly Reduced Incidence of RSV Disease and Hospitalization in Healthy Pret...
In the Phase 2b/3 trial, clesrovimab reduced RSV-associated hospitalizations (secondary endpoint) and RSV-associated lower respiratory infection hospitalizations (tertiary endpoint) by more than 84% a...
www.merck.com
October 18, 2024 at 3:19 PM
“Resistance was rare. Fewer than 1% of RSV sequences contained mutations that make them resistant to nirsevimab or a second monoclonal antibody called clesrovimab, sold as Enflonsia” www.cidrap.umn.edu/respiratory-...
No evidence RSV is mutating in response to infant immunizations, study finds
www.cidrap.umn.edu
October 1, 2026 at 10:18 PM
CLEVER phase 2b–3 trial: The burden of severe RSV disease is highest in the first 6 months of life, when prevention is needed. Research findings on clesrovimab ― a long-acting investigational monoclonal antibody against RSV fusion protein ― are summarized in a new Quick Take video. nej.md/42FOKzd
October 5, 2025 at 7:01 PM
ACIP and its work groups have previously examined clesrovimab at 3 prior meetings.

If you've heard that ACIP never votes "no," well, firstly, that's not true. Secondly, the reason that they basically always recommend a vaccine for someone is because vaccines are coming to them FDA-approved and...
June 25, 2025 at 6:36 PM
There is a vote today as well to include clesrovimab as a covered product under the Vaccines for Children Program. It passes.

The committee members also don't seem to know Robert's Rules and that's really icing on the cake.

Retsef Levi voted "yes" on this one.
June 26, 2025 at 1:00 PM
6/ RSV (infants): Monoclonal antibodies are not a vaccine. Nirsevimab or clesrovimab provide direct protection, cutting severe RSV by ~90%. Recommended for all infants under 8 months (unless mom got the RSV vaccine) and high-risk 8–19 month-olds. Get it between Oct–Mar for 5+ months protection.
September 2, 2026 at 7:44 PM
Kennedy's vaccine advisory group has voted to recommend the use of clesrovimab for use in children aged 8 months or younger (as an alternative to nirsevimab or maternal RSV vaccination).

Levi voted no because he thinks it is premature to roll out to the general population and should be...
June 26, 2025 at 12:55 PM
Newer injection of ready-made antibodies against RSV is safe in infants, a new study shows.
jamanetwork.com/journals/jam...
Clesrovimab in Infants at Increased Risk for Severe Disease During 2 RSV Seasons
This randomized clinical trial evaluates the safety and tolerability of single-dose clesrovimab across 2 respiratory syncytial virus (RSV) seasons in infants at high risk for severe RSV.
jamanetwork.com
September 9, 2026 at 5:25 PM
Clesrovimab Given in 1st and 2nd RSV Seasons for At-Risk Infants
After a comparative trial confirmed a single, long-acting dose of clesrovimab provides similar protection to monthly palivizumab injections for neonates and infants at risk of serious respiratory synctial virus (RSV) disease in their first season, an open label extension demonstrated clesrovimab effective and well-tolerated when repeated in their 2nd season.1 Heather Zar, MD, PhD, Department of Pediatrics & Child Health, Univeristy of Cape Town, Cape Town South Africa, and colleagues explain that while clesrovimab is approved for the prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season, "data concerning clesrovimab from a second RSV season among children who remain at risk for severe disease are needed." They point out that all infants are at risk for RSV disease in the first 6 months of life, but those born preterm and with comorbidities such as chronic lung disease of prematurity or congenital heart disease remain at increased risk in their second year of life. The investigators enrolled and randomized 1,003 infants for their first RSV season; of whom 997 were dosed, with 498 receiving a single 105mg injection of clesrovimab and 499 receiving up to 5 monthly injections of palivizumab 15mg/kg...
www.contagionlive.com
October 3, 2026 at 1:20 PM
#Medsky🧪 #IDsky #pedsky #pharmsky #publichealth In this phase III study, a single 105-mg dose of #clesrovimab was well tolerated in infants at increased risk for severe RSV disease in their first RSV season, with a safety profile vs to #palivizumab.

jamanetwork.com/journals/jam...
Clesrovimab in Infants at Increased Risk for Severe Disease During 2 RSV Seasons
This randomized clinical trial evaluates the safety and tolerability of single-dose clesrovimab across 2 respiratory syncytial virus (RSV) seasons in infants at high risk for severe RSV.
jamanetwork.com
July 21, 2026 at 4:47 AM
6/ RSV (infants): Monoclonal antibodies are not a vaccine. Nirsevimab or clesrovimab provide direct protection, cutting severe RSV by ~90%. Recommended for all infants under 8 months (unless mom got the RSV vaccine) and high-risk 8–19 month-olds. Get it between Oct–Mar for 5+ months protection.
September 8, 2025 at 9:44 PM
Could clesrovimab, a human RSV monoclonal antibody, reduce the incidence of RSV infection in preterm and full-term infants? Find out in the latest video in our partnership with @glaucomflecken.bsky.social. Read the full results of the CLEVER trial for free: nej.md/DrG30
November 18, 2025 at 8:03 PM
RSV remains a severe infection in infants and children. In this report, data on the activity of clesrovimab, a long-lasting RSV monoclonal antibody, are described as compared with palivizumab. Full interim results for the SMART phase 3 trial: nej.md/4poVkDE

#MedSky #IDSky #PedSky
September 17, 2025 at 9:45 PM