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UK-based Emergex Vaccines Holding Limited announced today that Swiss regulatory authorities, including the Swiss Agency for Therapeutic Products (Swissmedic), have granted approval for a Phase I clinical trial of the company's dengue vaccine candidate PepGNP-Dengue.

Emergex uses 100% synthetic vaccines to ‘prime’ naive CD8+ T-Cells to generate virus-specific CD8+ Cytotoxic T Lymphocyte cells to kill infected cells before productive viral infection, thus preventing viral replication and disease in the vaccinated person. 

The Phase I trial, named naNO-DENGUE, will evaluate Emergex’s novel T-Cell priming vaccine, designed to deliver broad and long-lasting immunity by priming the body’s T-Cell response to provide rapid clearance of infected cells in the event of an infection.

This double-blind, randomized, and comparator-controlled study will evaluate the safety of the investigational vaccine, PepGNP-Dengue. In addition, evidence of a T-cell mediated immune response as a surrogate of protection against severe Dengue disease will also be evaluated.

Athan Papadopoulos, Emergex Vaccines Chief Medical Officer, stated in a press release, “Emergex’s approach to vaccine development may offer significant potential benefits over existing approaches in terms of disease prevention and applicability to a range of serious diseases."

"T-Cells, as also seen lately, are one of the most important parts of the immune system. Without T-Cells, we could not survive. We are proud to be working on this program and welcome the opportunity to gather data to support the development of this novel technology.”

Emergex is a privately held biotechnology company headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania, USA.

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A study published by the JAMA Pediatrics on June 28, 2021, suggests that safety concerns or adverse effects as the main reason for refusing HPV vaccination increased over the years.

This finding has several important implications. First, given that concerns about vaccine safety are critical for vaccine confidence, rising safety concerns could negatively affect HPV vaccine uptake at the population level. Considering recent evidence of slowing routine HPV vaccination uptake, addressing safety concerns about vaccines should be of utmost public health importance.

Second, the findings of this study suggest that disinformation campaigns aimed at hampering vaccine trust are thriving. There has been a substantial rise of vaccine misinformation in the US that has culminated in public mistrust of vaccines.

The advent of social media and its exponential growth in popularity has spread misinformation to a wider audience within the general public. In some instances, misinformation has also been supported by influential public and political figures.

While these findings point to a need for widespread dissemination of educational programs within the general population, it is also crucial that public health agencies work with social media companies to develop campaigns to combat misinformation online.

Lastly, physicians have a crucial frontline role to play in addressing vaccine hesitancy during parent-physician encounters.

Despite several strengths of our study, including using a rigorously designed nationally representative sample, our study is not without limitations, including low response rate and potential nonresponse bias. However, statistical adjustments, including standard weighting procedures, have been applied to account for such potential biases.

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InnoCare Pharma announced that the U.S. Food and Drug Administration (FDA) had granted Breakthrough Therapy Designation (BTD) to its Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib for the treatment of relapsed or refractory mantle cell lymphoma (R/R MCL).

Orelabrutinib is a highly selective BTK inhibitor targeting both B-cell malignancy and autoimmune diseases.

Dr. Jasmine Cui, the co-founder, chairwoman, and CEO of InnoCare, said in a press release issued on June 28, 2021, “We are very proud that orelabrutinib was granted BTD after obtaining FDA Orphan Drug Designation."

"We will continue to uphold the concept of ‘Science drives innovation for the benefit of patients’ and accelerate clinical trials for multiple indications of orelabrutinib in China and the rest of the world to benefit patients worldwide.”

On December 25, 2020, orelabrutinib was approved by the China National Medical Products Administration in two indications: the treatment of patients with R/R CLL / small lymphocytic lymphoma and the treatment of patients with R/R MCL.

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Paris-based Sanofi announced today it would invest approximately €400 million (US$470 million) annually in a first-of-its-kind vaccine mRNA Center of Excellence. The Center of Excellence will enable acceleration of the vaccines mRNA portfolio developed through the Translate Bio collaboration established in 2018 and expanded in 2020.

Sanofi and Translate Bio have developed and will evaluate two formulations of the vaccine (MRT5400 and MRT5401) in the Phase 1 influenza mRNA vaccine clinical trial. The two formulations differ in the lipid nanoparticle that contains the mRNA.

The Center will accelerate the development and delivery of next-generation vaccines by bringing together approximately 400 dedicated employees integrating end-to-end mRNA vaccine capabilities with R&D, digital, and chemistry, manufacturing, and controls teams across sites at Cambridge, MA, and Marcy l’Etoile, Lyon, France.

“This massive new investment clearly puts us in the race to develop next-generation vaccines where mRNA technologies can have the greatest impact,” said Thomas Triomphe, EVP, Global Head of Sanofi Pasteur, in a press release.

“While mRNA won’t be the solution for every infectious disease, its translation into routine prevention could have an immense impact for many unmet public health needs. It now becomes a critical new technology in our comprehensive vaccines toolbox, one which could help reinvent health protection in the future.”

Sanofi is committed to rapidly establishing an industry-competitive mRNA platform and is working with our partners and all relevant stakeholders, internally and externally, to achieve this objective.

Sanofi and GSK are currently developing a COVID-19 vaccine candidate that combines innovative technologies to produce an adjuvanted recombinant protein-based vaccine. On May 27, 2021, Sanofi and GSK announced they started their Phase 3 clinical study enrollment.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

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Massachusetts-based Cerevel Therapeutics announced today positive results from its Phase 1b clinical trial of CVL-231, a novel muscarinic M4-selective Positive Allosteric Modulator (PAM), in adult patients with schizophrenia.

CVL-231 was found generally well-tolerated, and discontinuation rates were similar between CVL-231 and placebo in the six weeks of dosing, at 22% each.

Importantly, both the 30 mg once-daily and the 20 mg twice-daily doses demonstrated clinically meaningful antipsychotic activity with an overall well-tolerated profile compared with placebo.

The CVL-231 30 mg once-daily dose resulted in a statistically significant and clinically meaningful mean reduction from baseline of 19.5 points in the Positive and Negative Syndrome Scale (PANSS) total score and a mean reduction of 12.7 points in PANSS versus the placebo group (p=0.023).

The CVL-231 20 mg twice-daily dose resulted in a statistically significant and clinically meaningful mean reduction from baseline of 17.9 points in PANSS total score and a mean reduction of 11.1 points in PANSS total score compared with the placebo group (p=0.047).

“We believe these results are impressive and provide important evidence for the specific activation of the M4 receptor as a potential treatment approach for schizophrenia,” stated John M. Kane, M.D., professor and chairman, Department of Psychiatry at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell.

“By selectively targeting the M4 receptor, CVL-231 appears to have yielded a robust and clinically meaningful antipsychotic effect while avoiding both the debilitating extrapyramidal side effects commonly seen with dopamine antagonists, as well as the serious gastrointestinal side effects that have limited non-selective muscarinic compounds in the past.”

CVL-231 is designed as a once-daily medication that selectively targets activation of the M4 receptor in the brain to reduce dopaminergic activity without direct dopamine receptor antagonist activity. And, CVL-231 has the potential to be a first-in-class once-daily, M4-selective PAM that may provide antipsychotic activity without the need for titration while minimizing gastrointestinal, extrapyramidal, and metabolic side effects seen with other antipsychotic medications.

By selectively targeting the M4 receptor, CVL-231 has the potential to avoid the serious gastrointestinal side effects that have commonly been associated with, and have hindered clinical development of, non-selective muscarinic agents.

John Renger, Ph.D., chief scientific officer at Cerevel, added in the press statement, “By developing a molecule that is several hundred times more selective for M4 receptors over M1, M2, M3, and M5 receptors, we are expanding our understanding of how to best leverage the potential of the muscarinic pathway to effectively treat individuals with schizophrenia, with fewer of the dose-limiting side effects that occur with currently available therapies.”

The results of this trial support the advancement of CVL-231 into a Phase 2 program in schizophrenia. Cerevel also plans to explore additional related indications including dementia-related psychosis.

 Cerevel Therapeutics (Nasdaq: CERE), a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases.

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The AC Journals published an Original Article on June 29, 2021, focused on prostate cancer (CaP) treatment. The study authors aimed to assess the role of race-related treatment benefit in access to CaP treatment in a single-payer population.

The study used the Veterans Health Administration (VHA) Corporate Data Warehouse identified 35,427 men to perform a retrospective cohort study of veterans diagnosed with low- or intermediate-risk CaP between 2011 and 2017.

When they controlled for covariates, Black men at a VA facility had 1.05 times the odds of receiving treatment compared to non-Black men, and high-treatment-benefit men had 1.4 times the odds of receiving treatment compared to those in the low-treatment-benefit group.

And the interaction of race and treatment benefit was significant. Black men in the high-treatment-benefit category were less likely to receive treatment than non-Black men in the same treatment category (odds ratio, 0.89; P < .001).

The study author's conclusion was: Although race does appear to influence the receipt of definitive treatment in the VHA, this relationship varies in the context of the patient's treatment benefit, with Black men receiving less definitive treatment in high-benefit situations.

And, the influence of patient race at high treatment benefit levels invites further investigation into the driving forces behind this persistent disparity in this consequential group.

'Prostate cancer is the second most common cancer among men (skin cancer), but it can often be treated successfully. If you have prostate cancer or are close to someone who does, knowing what to expect can help you cope. Here you can find out all about prostate cancer, including risk factors, symptoms, how it is found, and how it is treated,' says Cancer.org.

The U.S. National Cancer Institute estimates that 248,000 men will be diagnosed with prostate cancer in 2021, most in its earliest stages.

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The JAMA Pediatrics published on June 28, 2021, a new article regarding the human papillomavirus (HPV) vaccine uptake in the USA. The HPV vaccine has been found effective at preventing several squamous cell carcinomas, yet the population-level uptake of HPV vaccines remains low.

Several factors contribute to HPV vaccine hesitancy and refusal; of note, safety concerns rank consistently high as a reason for HPV non-vaccination for adolescents by their parent or guardian.

Considering recent evidence of slowing routine HPV vaccination uptake, addressing safety concerns about vaccines should be of utmost public health importance.

Second, the findings of this study suggest that disinformation campaigns aimed at hampering vaccine trust. There has been a substantial rise of vaccine misinformation in the USA, culminating in public mistrust in vaccines during the COVID-19 pandemic.

'While our findings point to a need for widespread dissemination of educational programs within the general population, it is also crucial that public health agencies work with social media companies to develop campaigns to combat misinformation online.'

'Lastly, physicians have a crucial frontline role to play in addressing vaccine hesitancy during parent-physician encounters,' stated these researchers.

 

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Veru Inc. announced updated clinical results from the ongoing Phase 1b/2 clinical study of sabizabulin (VERU-111), an oral cytoskeleton disruptor being evaluated to treat metastatic castration-resistant prostate cancer in men who progressed on an androgen receptor targeting agent.

Sabizabulin, an oral, first-in-class alpha and beta-tubulin inhibitor/cytoskeleton disruptor small molecule for the treatment of metastatic castration-resistant and androgen receptor targeting agent resistant prostate cancer.

“The data from our Phase 1b/2 trial show that oral, daily sabizabulin is well tolerated and based upon its efficacy has the potential to fill the largest and growing unmet clinical need in men who have metastatic castration-resistant prostate cancer and who have developed progression of prostate cancer while being treated with an androgen receptor targeting agent, but before using IV chemotherapy,” said Dr. Mitchell S. Steiner, Chairman, President, and CEO of Veru Inc, in a press statement.

“We are excited to be initiating the Phase 3 VERACITY trial in this patient population.”

Dr. Robert H. Getzenberg, Veru, EVP for Medical Affairs, will lead a poster presentation at the European Association of Urology 36th Annual Congress being held virtually on July 11, 2021.

Miami-based Veru Inc. is an oncology biopharmaceutical company focusing on developing novel medicines for the management of prostate cancer and breast cancer.

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At the recent 2021 Annual Scientific Sessions of the American Diabetes Association, researchers from Massachusetts General Hospital (MGH) presented positive updates on their trials of the bacillus Calmette-Guérin (BCG) vaccine to safely and significantly lower blood sugars.

Currently, 143 type 1 diabetics have received at least two doses of the BCG vaccine, including 25 patients enrolled in a recently launched trial of adults who had pediatric onset. Pending FDA approval, MGH aims to launch a multi-center pediatric trial later this year.

In type 1 diabetes, an autoimmune disease that currently has no cure, says the U.S. CDC. T cells attack the pancreas and destroy its ability to create insulin, a hormone vital in allowing glucose to enter cells to produce energy.

In prior work, Denise Faustman, M.D., Ph.D., director of the MGH Immunobiology Laboratory, and colleagues have found that BCG boosts a substance called TNF, eliminating the harmful T cells and aids the development of beneficial ones called regulatory T cells, or Tregs.

Key findings include a new understanding of how the response to BCG vaccination differs depending on a patient's age of onset and additional support for the role of BCG vaccination to alter glucose transport and change Tregs.

"More data from randomized double-blinded clinical trials will be reported as we move towards additional readout of the Phase II trial," stated Dr. Faustman, principal investigator of BCG clinical trials at MGH, in a press release issued on June 25, 2021.

"We have continued evidence of BCG's ability to reset and restore the immune system."

In June 2018, MGH announced results of the follow-up of Phase I trial of BCG-treated long-term diabetic participants, showing lasting clinically and statistically significant drops in HbA1c values that persisted with eight years of follow-up.

"BCG is an old vaccine, but it seems to be presenting new gifts," says Nigel Curtis, M.D., Ph.D., of the Murdoch Children's Research Institute in Melbourne, Australia. He directs global clinical trials on the beneficial and off-target effects of the BCG vaccine but was not involved in the current study.

Merck's Bacille Calmette-Guerin vaccine is an attenuated, live culture preparation of the BCG strain of Mycobacterium Bovis. The TICE® strain used in the Merck BCG vaccine preparation was developed at the University of Illinois from a Pasteur Institute strain. The WHO recommends neonatal BCG vaccination in countries or settings with a high incidence of tuberculosis. 

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Beyfortus (Nirsevimab) RSV Antibody

Beyfortus™ (Nirsevimab) RSV Monoclonal Antibody Clinical Trials, Dosage, Efficacy, Side Effects

Beyfortus™ (Nirsevimab-alip) (MEDI8897) is the first approved single-dose, extended half-life monoclonal antibody (mAb) offering passive immunization to prevent lower respiratory tract infections (LRTI) caused by the respiratory syncytial virus (RSV) in newborns and infants experiencing their first or second RSV season and those with congenital heart disease or chronic lung disease. Beyfortus binds to the prefusion conformation of the RSV fusion protein and was developed in partnership with AstraZeneca and Sanofi using AstraZeneca's technology. In clinical trials, Beyfortus was approximately 90% (95% CI, 75%-96%) protective against RSV-associated hospitalization in infants during their first RSV season.

The concept of using passive immunization strategies to prevent severe RSV illness during infancy is not new. The first proof-of-principle results were obtained from studies conducted in the mid-1980s using animal models of RSV infection. Palivizumab, a humanized RSV-F mouse monoclonal IgG1, was first approved by the U.S. Food and Drug Administration (FDA) in 1998. On July 17, 2023, the FDA Approved Beyfortus. As of May 2025, RSVVaxView reported that nirsevimab coverage among infants <8 months (born since April 1) ranged from 20.5% to 48.2%. Among U.S. territorial and affiliated island jurisdictions, coverage ranged from 0% to 47.8%.

The World Health Organization (WHO) published the preferred product characteristics of monoclonal antibodies for passive immunization against RSV  disease. In September 2024, the WHO SAGE recommended that all countries introduce passive vaccination to prevent severe RSV disease in young infants. In 2025, more than 25 countries are expected to offer Beyfortus. Beyfortus was approved by the European Union (EU) on November 4, 2022. Beyfortus was recommended in AustraliaCanada, China, Europe  (EMEA/H/C/005304), Japan, and France. On July 25, 2024, the Ontario Ministry of Health announced a universal public program with Beyfortus. On May 29, 2025, data show that infant RSV hospitalizations in Spain decreased by 69% following immunization with BEYFORTUS, which targets infants only.

On May 8, 2025, the U.S. CDC MMWR reported a comparison of RSV-associated hospitalization rates among infants aged 0–7 months during 2024–25 with those during pre–pandemic RSV seasons, which were lower by an estimated 28% and 43%, respectively. On June 25, 2025, the CDC's ACIP reviewed a presentation titled "Effectiveness and Impact of RSV Prevention Products in Infants during the 2024–2025 RSV Season." On July 22, 2025, a study, published in PEDIATRICS®, an official journal of the American Academy of Pediatrics, met both of its co-primary endpoints, demonstrating that BEYFORTUS provides 87% reduction in cases of RSV disease across all sites of care among healthy, term babies, born ahead of or during the RSV season, and 98% reduction in hospitalizations of babies with RSV compared to those who did not get BEYFORTUS, per new post-hoc analysis.

Protein Chemical Formula: C6494H10060N1708O2050S46; Protein Average Weight: 146300.0 Da (approximate),  PubChem SID: 384585358, ChEMBL: ChEMBL4297575. CPT codes: 96380, 96381

In March 2017, Sanofi and AstraZeneca announced an agreement to develop and commercialize Beyfortus, with both companies sharing all costs and profits. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company. BEYFORTUS - Trademark Details: 90557485

Beyfortus (Nirsevimab) Effectiveness

In November 2025, a study reported that the preventive effect of nirsevimab against RSV infection was observed not only for the first 6 months, but also potentially for up to 12 months after the last dose in children younger than 24 months. On May 29, 2025, Sanofi presented BEYFORTUS® public health advantage of BEYFORTUS®, bolstered by the first real-world comparison of infant vs maternal RSV immunization programs. It's the first real-world findings from the REACH public health impact study, along with updated findings from the HARMONIE Phase 3b clinical trial. REACH Public Health Impact Data: Late-breaking data from REACH show infant RSV hospitalizations were reduced by 69.0% in Spain following Beyfortus-only immunization targeted to all infants and 26.7% in the UK following RSVpreF-only maternal vaccination. The real-world results suggest substantial differences in the public health impact of the respective campaigns. HARMONIE Durability Data: New durability data from HARMONIE show Beyfortus sustained efficacy of 83% through six months, exceeding the typical length of the five-month RSV season. Half of infant RSV hospitalizations occur in babies born before the RSV season begins. These six-month results suggest that older babies can have season-long protection even if they are born and immunized with Beyfortus before the season starts.

In April 2025, a study concluded that the prophylactic administration of Nirsevimab after delivery significantly affects (reduces) the burden of severe acute viral bronchiolitis in pediatric intensive care, while substantially reducing the cost of care. In October 2024, The Lancet published a study (Volume 8, Issue 10) estimating effectiveness against RSV-associated hospitalizations for bronchiolitis at 73% (61–84), corresponding to one hospitalization averted for every 39 (26–54) doses administered. On July 10, 2024, the New England Journal of Medicine reported that in a real-world setting, Beyfortus reduced the risk of infant hospitalization for RSV-associated bronchiolitis by 83%. The effectiveness of therapy against RSV-associated bronchiolitis resulting in critical care was 69.6% (95% CI, 42.9 to 83.8) (27 of 193 case-patients [14.0%] vs. 47 of 146 matched control patients [32.2%]) and against RSV-associated bronchiolitis resulting in ventilatory support was 67.2% (95% CI, 38.6 to 82.5) (27 of 189 case-patients [14.3%] vs. 46 of 151 matched control patients [30.5%]).

On September 11, 2024, a study published by the American Academy of Pediatrics (AAP) concluded that Beyfortus (Nirsevimab) could effectively protect a broad infant population against RSV infection: 63.1% reduction in acute bronchiolitis-related hospital admissions (95% confidence interval [CI], 60.9% to 65.2%), and a 63.1% reduction in pediatric intensive care unit admissions (95% CI, 58.1% to 67.9%). As of September 28, 2024, the AAP recommends Beyfortus for all infants who are not otherwise protected through vaccination during pregnancy. On November 14, 2024, the CDC reported that in Alaska, nirsevimab was 89% effective in preventing RSV-associated hospitalization for infants in their first RSV season and 76% and 88% effective against medically attended illness for children in their first and second seasons, respectively. On November 26, 2024, a study published in The Pediatric Infectious Disease Journal concluded that in immunized infants, RSV-positive bronchiolitis was less frequent and less severe, with a significant reduction in hospitalization length compared to nonimmunized infants, resulting in substantial healthcare cost savings.

On April 29, 2025, a study concluded that the introduction of Nirsevimab was significantly associated with a reduction in hospitalizations and a decrease in the severity of RSV and other respiratory infections. Its use was associated with fewer admissions and a reduced need for intensive care, especially in infants infected with RSV, as well as in those infected with HMPV and adenovirus.

On June 28, 2024, the U.S. CDC vaccine committee reviewed presentations confirming the effectiveness of Beyfortus. On June 5, 2024, the journal Influenza and Other Respiratory Diseases published a Short Communication that estimated nirsevimab's effectiveness at 75.9% (48.5–88.7) in the primary analysis and 80.6% (61.6–90.3) and 80.4% (61.7–89.9) in two sensitivity analyses. During that 2023-2024 RSV season in the U.S., Beyfortus reduced RSV  hospitalizations by 82% (95% CI: 65.6 to 90.2) in infants under six months of age, compared to infants who received no RSV intervention, according to the interim results of an ongoing study published in The Lancet on April 30, 2024. 

Beyfortus (Nirsevimab) Availability

As of 2025, Beyfortus has protected infants in over 20 countries. Beyfortus will be available in the U.S. for the 2025-2026 RSV season in 50 and 100-mg injection doses. The CDC is releasing VFC Beyfortus throughout the RSV season, which is typically first detected in Florida.

In 2023-2024, 40.9% of infants received nirsevimab at a median age of 4 days, according to a study published in JAMA Network Open. Among 42 state and city IIS jurisdictions, the geographic coverage of nirsevimab among infants under 8 months ranged from 2.4% to 22.8% in 2024. Among eight U.S. territorial and affiliated island jurisdictions, coverage ranged from 0.0% to 14.9%.

Beyfortus (Nirsevimab) U.S. FDA

The U.S. FDA Approved Beyfortus in July 2023. The Vaccines and Related Biological Products Advisory Committee (VBPVAC) meeting on December 12, 2024, reviewed presentations on RSV immunization. The FDA's Antimicrobial Drugs Advisory Committee met on June 8, 2023, to discuss the Briefing Document and presentations (2) for the biologics license application (BLA) 761328 submitted by AstraZeneca AB for use with certain neonates, infants, and children. The Committee voted 21-0 in favor of approval. If approved by the FDA, nirsevimab could be available in the U.S. for the 2023/2024 RSV season. On February 5, 2019, the FDA granted Breakthrough Therapy Designation for MEDI8897, an extended half-life RSV F mAb, for the prevention of lower respiratory tract infections (LRTIs) caused by RSV.

Beyfortus (Nirsevimab) U.S. CDC

As of July 2024, the U.S. Centers for Disease Control and Prevention (CDC) recommends passive immunization to protect all infants under 8 months of age and some older babies at increased risk of severe RSV illness. The CDC Advisory Committee on Immunization Practices (ACIP) meeting on June 28, 2024, reviewed various presentations. On August 3, 2023, the ACIP reviewed recommendations, updated nirsevimab EtR, feasibility and implementation plans for monitoring safety and effectiveness in the second season, and Clinical considerations. The ACIP voted unanimously to include Beyfortus in the Vaccines for Children program and to use it in all infants under 8 months.

The CDC Morbidity and Mortality Weekly Report confirmed in March 2024 that the effectiveness was approximately 90% against RSV-associated hospitalizations in infants during their first RSV season. On January 4, 2024, the CDC advised healthcare providers to return to the recommendations (CDCHAN-00499) from the CDC and the Advisory Committee on Immunization Practices (ACIP) regarding the use of nirsevimab in young children. Infants and children who are recommended for nirsevimab should be immunized as soon as possible.

The ACIP previously met on June 22, 2023, and reviewed Clinical Considerations for RSVpreF maternal vaccine and nirsevimab, presented by Jefferson Jones, MD, MPH, FAAP. On February 23, 2023, the ACIP reviewed presentations on the following topics: Introduction, Cost-effectiveness analysis for nirsevimab – CDC model; Cost-effectiveness analysis for nirsevimab – Comparison to manufacturer model; Evidence to Recommendations framework for nirsevimab; Clinical considerations for nirsevimab; Safety and Efficacy of RSV Bivalent PreF Maternal Vaccine; and Workgroup considerations. On October 20, 2022, Dr. C. Felter presented the updated safety and efficacy of Nirsevimab to the ACIP. Previously, the ACIP meeting on June 23, 2022, reviewed Nirsavimab for The Prevention of RSV Disease in All Infants.

Beyfortus (Nirsevimab) Indication

In June 2021, the World Health Organization (WHO) published its preferred product characteristics for long-acting monoclonal antibodies (mAbs) for passive immunization against respiratory syncytial virus (RSV) disease in infants and children (as of June 2022). Nirsevimab is designed to be administered to infants born below eight months of age during the RSV season or children entering their first or second RSV season. Beyfortus is approved for use in infants who remain vulnerable to severe RSV disease through their second RSV season. RSV is a common, contagious virus that causes seasonal epidemics of LRTI, leading to bronchiolitis and pneumonia in infants. The Lancet published results from a study in February 2024 that concluded preterm infants accounted for about 25% of the RSV hospitalization burden in a meta-analysis. On October 26, 2023, the CDC hosted a COCA webinar, "Protecting Infants from RSV," which discussed the fact that approximately 2–3% of young infants are hospitalized for RSV. In Canada, the National Institute of Excellence in Health and Social Services recommends BEYFORTUS for the prevention of RSV LRTD in all neonates and infants aged 8 months or younger.   

Beyfortus (Nirsevimab) Dosage

Beyfortus is injected into the thigh muscle once. The recommended dose is 50 mg for children weighing less than 5 kg and 100 mg for children weighing 5 kg or more.

Beyfortus (Nirsevimab) Mechanism of Action

Nirsevimab is a recombinant human immunoglobulin G1 kappa (IgG1ĸ) long-acting mAb that binds to the prefusion conformation of the RSV F protein. RSV is coated with two types of glycoproteins: the attachment glycoprotein (G protein) and the fusion glycoprotein (F protein). Of these two, only the F protein is essential for the virus to enter cells lining the respiratory tract, making it a desirable target for drug development. The RSV F protein is initially in a metastable prefusion state and undergoes conformational changes upon triggering by an unknown event. These conformational changes lead to a postfusion conformation, in which both the viral and host-cell membranes are together. Nirsevimab binds to a highly conserved RSV prefusion F protein epitope, inhibiting the membrane fusion step in the viral entry process. This allows nirsevimab to neutralize various RSV A and B strains and block cell-to-cell fusion. Nirsevimab has also been modified with a triple amino acid substitution (M257Y/S259T/T261E [YTE]) in the Fc region to extend serum half-life from the typical 21–28 days to approximately 69 days.

Beyfortus (Nirsevimab) CPT Codes

As of October 6, 2023, the American Academy of Pediatrics (AAP) has approved two new Current Procedural Terminology (CPT) codes related to the administration of nirsevimab. One of these codes accounts for the work associated with providing counseling: 96380 Administration of RSV monoclonal antibody, seasonal dose, by intramuscular injection, with counseling by a physician or other qualified healthcare professional; and 96381 Administration of RSV monoclonal antibody, seasonal dose, by intramuscular injection.

Beyfortus Drug Safety-Related Labeling Changes

The price you pay for Beyfortus may depend on your child's dosage and whether you have health insurance. Severe hypersensitivity reactions (02/23/2024, SUPPL-7) have been reported following administration of BEYFORTUS. These reactions included urticaria, dyspnea, cyanosis, and/or hypotonia. Anaphylaxis has been observed with human immunoglobulin G1 monoclonal antibodies. If signs and symptoms of anaphylaxis or other clinically significant hypersensitivity reactions occur, initiate appropriate treatment.

Beyfortus Adverse Reactions Postmarketing Experience

Adverse reactions have been identified during the post-approval use of BEYFORTUS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or establish a causal relationship to drug exposure.

Sanofi SP0125

The Phase 3 clinical study evaluating the Sanofi SP0125 (VAD00001) live attenuated vaccine to prevent RSV in toddlers is expected to begin in 2024. SP0125 is administered through the nasal route.

Beyfortus (Nirsevimab) Price

Sanofi launched the BEYFORTUS Reservation Program, which provides critical insight into private healthcare provider demand and prioritizes fulfilling requests through the program. In Canada, each dose costs the province $1000.

On November 16, 2023, the CDC announced the release of Beyfortus to physicians and hospitals through the Federal Vaccines for Children Program and commercial channels. The Ordering Vaccines webpage provides additional guidance on ordering vaccines in the United States. On February 23, 2023, the U.S. CDC reviewed presentations: A cost-effectiveness analysis for nirsevimab—CDC model and a cost-effectiveness analysis for nirsevimab—Comparison to manufacturer model.

Beyfortus Sales

In April 2025, Sanofi announced that Beyfortus sales reached €284 million, driven by increased sales in the Northern Hemisphere, particularly in Germany and Japan. On January 30, 2025, Sanofi announced that Beyfortus sales were €841 million, driven by additional sales in Europe, Germany, and the U.S. The company announced on October 25, 2024, that during Q3, 15.7% sales growth was boosted by earlier-than-anticipated vaccine sales. Beyfortus sales totaled €645 million, driven by early delivery in the U.S. and the rollout in approximately 20 countries in 2024. Beyfortus sales totaled €18 million (USD 19.6 million) in the second quarter of 2024.

Beyfortus (Nirsevimab) News

July 22, 2025 - Ayman Chit, Head of North America Medical, Vaccines, Sanofi, stated in a press release, "These results support BEYFORTUS as a groundbreaking advancement in infant RSV disease prevention. With more than 40 real-world evidence studies to date, this latest study further strengthens the well-established body of data that shows that BEYFORTUS protects against RSV disease to help safeguard the health of all babies, regardless of whether they are born before or during the RSV season."

May 29, 2025 - Thomas Triomphe, Executive Vice President, Vaccines, Sanofi, stated: "The six-month data from HARMONIE show BEYFORTUS' protection exceeded the typical five-month RSV season. This is important because half of infant RSV hospitalizations occur in older babies born before the RSV season begins. These data demonstrating high, sustained efficacy, combined with real-world public health impact data, underscore how BEYFORTUS provides proven protection against the number one cause of lower respiratory tract disease in all infants."

December 9, 2024 - An Original Investigation: Respiratory Syncytial Virus Disease Burden and Nirsevimab Effectiveness in Young Children From 2023-2024 - nirsevimab was effective against RSV-associated hospitalization.

July 25, 2024—The Honourable Sylvia Jones, Ontario Deputy Premier and Minister of Health, commented, "Our government is taking steps to ensure Ontarians of all ages have the tools to be prepared and keep their loved ones safe and healthy before respiratory virus season. Our government is working with our partners to significantly expand Ontario's RSV program to make it easier for families to connect to the care they need, improve health outcomes, and reduce the number of hospitalizations and ICU admissions resulting from RSV."

June 28, 2024: The U.S. CDC vaccine committee reviewed various data presented by Amanda Payne, PhD, MPH, which support the continued use of Beyfortus for most infants during the 2024-2025 RSV season.

April 18, 2024—Delphine Lansac, General Manager of Vaccines Canada at Sanofi, said in a press release, "Parents and physicians who experience the impacts of RSV annually have been waiting for a preventative option that can cover the entire infant population and protect our most vulnerable.

January 2, 2024 - Professor Liu Hanmin, President of West China Second University Hospital, Sichuan University, commented in a press release, "There is currently no specific treatment for RSV disease in infants. This approval (Beyfortus) is crucial to preventing and controlling RSV disease in China."

December 14, 2023: The companies wrote, "We plan to provide approximately 230,000 additional doses—made up of 50mg and 100mg doses—for the U.S. in January. This would bring the first season's immunization rate to nearly 40 percent, significantly surpassing the prior pediatric immunization launch rates. A total of 1.4 million babies will be offered protection against RSV, a 27 percent increase over the initial supply forecast for the season.

August 3, 2023 - Thomas Triomphe, Executive Vice President of Vaccines, Sanofi, commented, "Today, we have turned the corner on the threat of RSV to our youngest, most vulnerable population. The ACIP's unanimous recommendations for the routine use of Beyfortus and its inclusion in the Vaccines for Children program are critical steps toward providing millions of parents in the U.S. with the ability to protect their babies through their first RSV season, when they are most susceptible to severe RSV disease. We appreciate the leadership of the FDA and CDC, as well as the ACIP public health experts, for recognizing and quickly acting on the threat that RSV poses to all infants. "May 12, 23—Thomas Triomphe, Executive Vice President of vaccine lines at Sanofi, stated, 'the HARMONIE data demonstrate the real-world impact  nirsevimab has on pediatric hospitalizations and illustrate its importance for infants, their families, and public health." November 4, 2022 - AstraZeneca and Sanofi announced that the European Commission had approved Beyfortus in the EU to prevent RSV lower respiratory tract disease in newborns and infants during their first RSV season.

May 11, 2022 - AstraZeneca announced results from a prespecified pooled analysis of the pivotal MELODY Phase III and Phase IIb trials showed AstraZeneca and SSanofi'snirsevimab demonstrated an efficacy (relative risk reduction versus placebo) of 79.5% (95% Confidence Interval [CI] 65.9 to 87.7; P<0.0001) against medically attended lower respiratory tract infections (LRTI), such as bronchiolitis or pneumonia, caused by RSV in infants born at term or preterm entering their first RSV season.

March 3, 2022 - Sanofi announced the New England Journal of Medicine published detailed results from a Phase 3 trial evaluating nirsevimab involving healthy infants born at term or late preterm (35 weeks gestational age or more significant) entering their first RSV season and met the primary endpoint, reducing the incidence of medically attended lower respiratory tract infections, such as bronchiolitis or pneumonia, caused by RSV by 74.5% (95% CI 49.6 to 87.1; P<0.001) compared to placebo.

August 11, 2021 - A peer-reviewed study concludes that, based on the mechanism of action of the new generation of antiviral mAbs, such as nirsevimab, which is highly specific in targeting viral antigenic sites, it is unlikely that it could interfere with the immune response to other vaccines.

March 3, 17—Sanofi Pasteur announced Today an agreement with the global biologics research and development arm of AstraZeneca to develop and commercialize MEDI8897, a monoclonal antibody 897, for the prevention of RSV-associated illness in newborns and infants. 

Beyfortus (Nirsevimab) Clinical Trials

Nirsevimab has been tested in several clinical trials. The primary endpoint (prevention of MA RSV was met in both trials: TI—Trial 03 RRR 70.1%, 95% CI (52.3%, 8, and 2%); TI—Trial 04 Primary Cohort RRR 74.9%, 95% CI (50.6%, 87.3%).

The JAMA Network published an Original Investigation on February 17, 2023, suggesting Beyfortus is associated with substantial benefits in preventing RSV infection in children. The peer-reviewed New England Journal of Medicine (NEJM) published a Correspondence on April 5, 2023, Nirsevimab for Prevention of RSV in Term and Late-Preterm Infants, and published a different Correspondence on March 3, 2022: Safety of Nirsevimab for RSV in Infants with Heart or Lung Disease or Prematurity. Found that at day 151, serum levels of nirsevimab were similar in the two cohorts and identical to those reported in the MELODY phase 2/3 clinical trial. The Phase 3 clinical study, Understanding Pre-Exposure Prophylaxis of NOVel Antibodies (SUPERNOVA), was last updated on April 3, 2023.

On May 12, 2023, Sanofi announced new data from the HARMONIE Phase 3b clinical trial show an 83.21% (95% CI 67.77 to 92.04; P<0.001) reduction in hospitalizations due to RSV-related LRTD in infants under 12 months of age who received a single dose of Beyfortus, compared to infants who received no RSV intervention. In addition, the data from HARMONIE also show that nirsevimab reduced the incidence of hospitalizations due to severe RSV-related LRTD (patients whose oxygen level is under 90% and require oxygen supplementation) by 75.71% (95% CI 32.75 to 92.91; P<0.001), and demonstrated a reduction of 58.04% in the incidence of all-cause LRTD hospitalization compared to infants who received no RSV intervention. On December 28, 2023, results (0.3% of those who received nirsevimab were hospitalized for RSV-associated lower respiratory tract infection compared with 1.5% of those who received standard care) from the HARMONIE clinical study indicated that Beyfortus protected infants against hospitalization for RSV-associated LRTD and against very severe RSV-associated lower respiratory tract infection in conditions that approximated real-world settings.

 In the MELODY and Phase 2b trials, the post-dose endpoint for Beyfortus was to reduce the incidence of medically attended lower respiratory tract infections (LRTIs) caused by RSV during the RSV season compared to placebo, achieved with a single dose. The Phase IIb study was a randomized, placebo-controlled trial designed to assess the efficacy of Beyfortus against medically attended lower respiratory tract infections (LRTIs) through post-dose. Healthy preterm infants of 29–35 weeks gestation were randomized (2:1) to receive a 50mg intramuscular injection of Beyfortus or a placebo. The dosing regimen was recommended following further analysis of the Phase IIb data. In the subsequent Phase III study, MELODY applied the recommended dosing regimen.

The MELODY Phase III study was a randomized, placebo-controlled trial conducted in 21 countries. Its purpose was to determine the efficacy of Beyfortus against medically attended lower respiratory tract infections (LRTIs) due to respiratory syncytial virus (RSV), as confirmed by reverse transcriptase polymerase chain reaction testing 150 days after dosing, versus placebo in healthy late preterm and term infants (35 weeks' gestational age or more) entering their first RSV season.

MEDLEY was a Phase II/III, randomized, double-blind, Synagis-controlled trial to assess safety and tolerability for Beyfortus in preterm infants and infants with congenital heart disease and/or chronic lung disease of prematurity (CLD) eligible to receive Synpost-dose9 Between July 2019 and May 2021, approximately 918 infants entering their first RSV season were randomized to receive a single 50mg (in infants weighing <5kg) or 100mg (in infants weighing ≥5kg) intramuscular injection of Beyfortus or Synagis. Safety was assessed by monitoring the occurrence of TEAEs and TESAEs through post-dose. Serum levels of Beyfortus following dosing (on day 151) in this trial were comparable to those observed in the MELODY Phase III trial, indicating similar protection in this population to that in healthy term and late preterm infants is likely. The data was published in the New England Journal of Medicine in March 2022.

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Availability: 
USA, Europe, U.K., Canada, China, Japan
Generic: 
Nirsevimab
Clinical Trial: 
https://www.sanofi.com/en/science-and-innovation/clinical-trials-and-results
Drug Class: 
Monoclonal Antibody
Last Reviewed: 
Sunday, November 9, 2025 - 02:00
Brand: 
Beyfortus
Abbreviation: 
MEDI8897
Status: 
Manufacturer Country ID: 
FDA First In Class: 
Yes
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